Q3 2021 Zai Lab Ltd Earnings Call

November 10, 2021

Yeah.

Operator: Ladies and gentlemen, today's conference call is due to begin shortly. Until such time, your lines will remain on music hold. Please continue to stand by. We thank you for your patience.

And gentlemen, todays conference call is due to begin chunky.

Unknown Speaker: Unsponsored ADR Unsponsored ADR Unsponsored ADR

Operator: Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's third quarter 2021 Financial Results Conference call. At this time, all participants are in a listen-only mode.

Your lines will remain on music hold he's got to get this done by your thank you for your patients.

Operator: Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Mr. Billy Cho, Chief Financial Officer of Zai Lab, who will make introductory comments. Thank you, Operator. Good morning and welcome, everyone.

[music].

Hello, Ladies and gentlemen, thank you for standing by and welcome to <unk> third quarter 2021 financial results conference call. At this time, all participants are in a listen only mode.

We will conduct a question and answer session and instructions will follow at that time.

Unknown Attendee: Zai Lab recently issued a press release providing the details of the company's financial results for the third quarter ended September 30, 2021, as well as product highlights and corporate updates. The press release is available in the Investor Relations section of the company's corporate website at ir.zailaboratory.com. Today's call will be led by Dr. Samantha Du, Zai Lab's Founder, Chairperson, and Chief Executive Officer. She'll be joined by Jonathan Wang, Head of Business Development, to discuss our recent collaboration for three new potentially transformative Dr. Alan Fandler, President and Head of Global Development Oncology, who will discuss advances with our Oncology Product Candidates. Dr. Harald Reinhart, GMO, autoimmune, and infectious diseases, who will speak about progress made in two therapeutic areas.

Today's call is being recorded.

It is now my pleasure to turn the floor over to Mr. Billy Joel Chief Financial Officer, All beside lab, who will make introductory comments.

Thank you operator.

Good morning, and welcome everyone.

I Love recently issued a press release provided the details of the company's financial results for the third quarter ended September 32000.

'twenty, one as well as product highlights and corporate updates.

Press release is available in the Investor Relations section of the company's corporate website at IR thoughts I laboratories alcohol.

Today's call will be led by both this message.

Its founder chairperson and Chief Executive Officer, she'll be joined by Jonathan Wang head of.

Business development to discuss a week a collaboration with three new potentially transformative medicine Doctor on Sandler President and head of global development of oncology, who will discuss the dances with our oncology product candidates.

Harold Lighthart, CMO autoimmune and infectious diseases, who will speak about progress we've made in two therapeutic areas pulp Hu Chief strategy Officer, who will discuss the performance of our market products and I'll conclude with comments on our financial results in the quarter will all be available to answer questions. During the Q&A portion of the call.

Unknown Attendee: Tao Fu, Chief Strategy Officer, who will discuss the performance of our market products, and I will conclude with comments on our financial results for the quarter, will all be available to answer questions in the Q&A portion of the call. As a reminder, during today's call, Zai Lab will be making certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including our business plans and objectives, and the timing and success of our clinical trials, regulatory applications, and commercial law enforcement.

As a reminder.

Today's call dialog will be making certain forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995, including our business plans and objectives and timing and success of our clinical trials regulatory applications and commercial launches such forward looking statements are not guarantees of future performance and therefore, you should not put undue we like.

Unknown Attendee: This forward-looking statement does not guarantee future performance and therefore should not be relied upon undue reliance. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. I refer you to our SEC filings for a discussion of risk factors that could cause our actual results to differ materially from those discussed today. At this time, it is my pleasure to turn the call over to GILAD's Founder, Chairperson, and Chief Executive Officer, Dr. Samantha Duke.

Upon them.

These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect I refer you to the SEC filings for a discussion of risk factors that could cause our actual results to differ materially from those discussed today.

This time it is my pleasure to turn the call over to Guy, that's founder Chairperson and Chief Executive Officer, Dr. Samantha Du.

Thank you Billy.

Ying Du: Hello everyone, and thank you all for joining us. On this call, I'll discuss highlights from our third quarter, including two exciting new deals we announced yesterday, will give you the latest update on what we expect to accomplish in the fourth quarter and beyond, will continue to deliver strong growth and performance across our entire business, and made important advances across our innovative portfolio, which we continue to differentiate in terms of the steps and breadth.

Hello, everyone and thank you all for joining us.

On this call I will discuss.

Highlights from our third quarter.

<unk> two exciting new tool we have now.

I'll give you the latest update what they expect to accomplish in the fourth quarter and beyond.

Yes.

But continuing to deliver samples and postpone them.

Cross our entire business.

We made important advances across our innovative products.

Total formula.

We continue to differentiate in terms of the depth and breadth.

Ying Du: I'm very pleased to share with you that we expanded our product portfolio both vertically and horizontally by establishing partnerships for three new potentially first-in-class and or best-in-class products. Our agreement with Brooklyn Medicine for two promising lung cancer compounds, BLU945 and BLU701, presents opportunities to further expand our world-class lung cancer franchise. Our deal with Corona Therapeutics allows us to enter a whole new therapeutic area, neuroscience, with an exciting on-premises CAR-XT. Jonathan Wang will provide additional details about this product in the third quarter of 2021. Zai Lab made significant progress across all fronts, including R&D, BD, regulatory, and commercial.

Very pleased to share with you separately.

Our product portfolio.

So I'm pretty I established partnerships for three new potentially first in class.

Oh best in class product.

Our agreement with Buchu medicine.

Two promising long types of compounds.

Slide five includes several one cause.

Is that an opportunity to further expand dollar walkoff lung cancer franchise.

Our deal with Komal Therapeutics allows us to enter a whole new therapeutic area.

Sun isn't exciting I'm correct that car T jumping Wong who will provide additional details about this product.

In the third quarter of kidney to pier one.

Satellite Mi music and progress across all fronts, R&D BP regulatory and commercial.

Ying Du: We continue to generate strong revenue growth from Zazula, Upchung, and Kimlab. We had a positive meeting with the MMTA on Oscar Tigma, which suggests the potential for an accelerated pathway for regulatory approval for GMG in China. Subject to FDA approval and further discussion with the MMPA, we expect to file the MDA in China by the first half of 2022. We announced exciting data from the ATT&CK clinical trials for sebectum and gerbectum, and we will now proceed to prepare regulatory silence. We achieved clinical proof of concept for CL1102, our L17A novel VH antibody fragment for topical treatment.

We continue to generate strong revenue growth.

All of tone.

Locke.

We had a positive meeting with and then P. A of course pick them up.

Suggests the potential accelerated pathway from SATA to cool the GMT in China.

Subject to FDA approval and further discussion with an NPA.

Expect to file the NDA in China, but the first half of 2022.

Yeah no.

Data from the clinical trials post backed home drove back to them and we will now proceed to prepare regulatory filings.

We achieved clinical proof of concept.

I'll elaborate more tool.

Our IL 17, a novel antibody fragment well topical treatment.

Well small too small to mid Pike Plaza.

Ying Du: Unsponsored ADR, Demonstrating proof of concept for GL-1102 is an important milestone for Zai Lab in our effort to discover and develop a pipeline of internally developed Products with Global Rights and to expand to as many locations as possible worldwide. Innovation, several of our innovative product candidates have exciting data updates at recent medical meetings. Alan, Harold, and Paul will elaborate on those policy developments in a few minutes.

Penetrating proof of concept for T O.

True with many important milestones since I left another effort to discover and develop a pipeline of internally developed.

With global rights.

Spun too many indications as possible worldwide.

In addition, several of our innovative products.

At least I didn't papers update at recent medical meetings.

Island hurdles and Paul will elaborate on both parts of the development.

A few minutes.

Jonathan J. Wang: We continue to expect approval of Muzera for community-acquired bacterial pneumonia and acute bacterial skin structure infection by the MMPA in the fourth quarter. We are making progress in preparing a record refining for tumor treating fields in Ethiopia, Oman, and marked on the map in the branch country. And we expect to enroll patients in China for numerous global clinical trials over the next several quarters. We now have 28 globally innovative assets in our pipeline, and the quality, depth, and breadth of our pipeline continue to grow from strength to strength.

We continue to expect approval of Missoula for community acquired bacterial pneumonia and acute bacterial skin and skin structure infection by the and then P. In the fourth quarter.

We are making progress in preparing our regulatory filing for tumor treating fields, they need to see the old mall mark to some that breast cancer.

And we expect to enroll patients in China, numerous global clinical trials over the next several quarters.

We now have 28 globally.

It's not a platform.

The quality depth and breadth of our pipeline continues to go from since Kristen.

Jonathan J. Wang: 13 products are in late phase development, of which five have already been approved in the U.S., and four have received FDA breakthrough therapy designation. In addition, our Green Pipeline includes 11 early stage programs with worldwide rights, including three in global clinical trials, and one that achieves PRO concept and is advancing into full development. We have had a very productive year so far. For 2021, we expect our fourth quarter of 2022 to be reaching milestones to unlock significant value in our business. With that, I'll now ask Jonathan to speak about our two collaborations. Jonathan.

13 product safety.

Sales development.

Reach five have already been approved but anyway.

Toll has received FDA breakthrough therapy designation.

In addition, our current pipeline includes 11 early stage programs worldwide rights, including three in global clinical trials and one that's achieved pool concept.

Hum.

All right.

We have had a very productive year so far.

'twenty one we expect.

Our fourth quarter, and <unk> 22 to be reaching milestones.

Lost significant value in our business.

With that I'll now ask something to speak about our true collaboration Jonathan.

Jonathan J. Wang: Thank you, Samantha. As Matthew mentioned, Yesterday, we announced two strategic collaborations that further strengthen and broaden our pipeline. Agreement with Blueprint, planning for the two next-generation EGFI inhibitors. Blue 945 and Blue 701 would significantly strengthen our established lung cancer franchise and precision medicine portfolio, one of our most important focus areas where we have multiple late-stage assets that are complementary to each other. You may know that lung cancer is the most commonly diagnosed cancer type and is the leading cause of cancer death in China. The annual incidence of lung cancer in China is more than 800,000 cases, of which non-small cell lung cancer accounts for approximately 85%.

Thank you Samantha.

And as I mentioned, yes.

Yesterday, we announced two strategic collaborations that further strengthen and broaden our pipeline.

Our agreement with blueprint Henri on the two next generation Egfr inhibitors.

945, and Blu 701 would significantly strengthen now established lung cancer franchise and precision medicine portfolio one of our most important focus areas, where we have multiple late stage assets.

Complementary with each other.

You'll recall that lung cancer is the most commonly diagnosed cancer type one of the leading cause of cancer death due to China.

Yeah.

Of lung cancer in China is more than 800000 places.

Of which non small cell lung cancer accounts for approximately 85%.

Egfr mutations are more common in China that you would be United States.

Jonathan J. Wang: EGFR mutations are more common in China than in the United States, occurring in 40-50% of non-smart cell lung cancer patients, and these two compounds target the largest subpopulation in lung cancer in China. Third-generation EGFR TTIs, such as Ozymedonib, are commonly prescribed and have emerged as a standard of care for the first-line setting. However, resistance inevitably emerges, leading to disease progression.

Occurring 40% to 50% of non small cell lung cancer patients.

And these two compounds private the largest population in lung cancer a chart.

We have generated.

<unk> Egfr PKI okay.

Internet company.

Commonly prescribed and have emerged as the standard of care for the first line setting.

However, resistance inevitably emerges leading to disease progression.

Jonathan J. Wang: There are no approved therapies for patients with disease progression following third-generation EGFR treatment. These two compounds from Blueprint are potentially first and or best-in-class fourth-generation EGFR inhibitors, and together with our other lung cancer products, will enable Zai to cover nearly all the different patient populations for this deadly disease. Blue 945 is a potential first-in-class inhibitor of simple mutant EGFR covering either the activating LA58R or exon 19 deletion mutations, combined with the acquired C790N and C797F mutations.

There are no approved therapies for patients with disease progression following third generation Egfr treatment.

These two compounds from blueprint, our potentially first and go best in class fourth generation Egfr inhibitors.

And together with our other lung cancer product.

I would like to cover nearly all of the different patient population for this deadly disease.

<unk> is a potential first in class inhibitor of Triple mutant Egfr harboring either be activating L. A R.

Oh, exon 19 deletion mutation.

Combined with the acquired 790 and seven.

97 <unk> mutation.

Jonathan J. Wang: It is potent and has demonstrated high wild-type EGFR selectivity to enable its use in combination, and it has shown anti-tumor activity both alone and in combination with RTD in preclinical studies. They entered a Phase 1-2 clinical trial earlier this year. B701 is a selective EGFR double neutrino, providing potential best-in-class coverage of activating EGFR mutations, plus coverage of the major on-target resistance mutation for autism, which is the C797S mutation. It is also highly potent and crosses the blood-brain barrier, which is important because in EGFR-nutrient non-small cell lung cancer patients with baseline brain metastasis, up to 40% of disease progression involves CNS metastasis.

Is potent and has demonstrated high wild type Egfr selectivity.

It's used in combination.

And it has shown antitumor activity both alone and in combination with all the pre clinically.

They entered a phase one two clinical trial earlier this year.

Blu 701 is a selective egfr double mutant inhibitor, providing potential best in class coverage of activating Egfr mutation.

Coverage of the major on target resistance mutation for Augie.

797 S mutations.

It is also highly potent and crosses the blood brain barrier.

Because in Egfr mutant non small cell lung cancer patients.

Baseline brain metastasis up to 40% of disease progression.

In both CNS metastases.

Jonathan J. Wang: Blue 701 is expected to begin phase one clinical trials before the end of the year. The development strategy for these two compounds is either as monotherapy or in combination together or with other agents to overcome or prevent on-target resistance across multiple lines of treatment. In addition, this collaboration enables opportunities to combine Blue 945 or Blue 701 with other Zai Lab lung cancer drug candidates to address off-target resistance mutations. Yesterday, we also announced an exciting collaboration with Karuna to exclusively develop and commercialize car XP for Schizophrenia and Dementia-Related Psychosis in Greater China.

Blu 701 is expected to begin phase one clinical trials before the end of the year.

The development strategy you put these two compounds.

Either as monotherapy or in combination together with other agents.

Overcome or prevent on target resistant across multiple lines of treatment.

In addition.

This collaboration enables opportunity the combined blue non call five or Blu 701, with other violent lung cancer drug candidates.

Our cargo resistance mutation.

Yesterday, we also announced an exciting collaboration with Corona exclusively developed and commercialized car T.

Or it's a premia in dementia related psychosis in greater China.

Jonathan J. Wang: We already have several products in urology, including F-carcinomas. So this is an adjacent expansion for Zai, and CAR-XT can leverage our existing infrastructure to create synergy. S. Scott Gates, Zai Lab, and Anchor Asset in Autoimmune Disorders. We believe CARXT will do the same for us in Europe. It is a late-stage asset with first-in-class potential in a disease area with a large patient population and significant market and medical need. There are an estimated 8 million schizophrenia patients in China. The target population for dementia-related psychosis in China is about 2 million patients.

We already have several product neurology, including aircraft demand.

This is an adjacent expansion for di and car T can leverage our existing infrastructure to create synergy.

It's got great dialogue and anchor asset in autoimmune disorders, We believe <unk> will do the same for us of your clients.

It is a late stage assets with best in class potential disease area with a large patient population and significant unmet medical needs.

The estimated 8 million schizophrenia patients in China, and the target population for dementia related psychosis in China is about 2 million patients.

Unknown Attendee: Power XT is a phase 3 asset with strong phase 2 data and significant differentiation from existing treatments. In the Phase 2, Emerging 1 clinical trial, it showed good efficacy in pan-SS scores, particularly in negative symptoms of schizophrenia, such as apathy, lethargy, lack of pleasure, reduced speech, and withdrawal. It also was well tolerated and demonstrated a favorable safety profile compared to existing therapies. Overall, these two collaborations vertically and horizontally extended our pipeline, and we look forward to bringing in more deals for innovative and differentiated products such as these. And now, I'll turn the floor over to Dr. Fangla, Alan. Thank you, Jonathan.

Correct.

A phase III asset with strong phase II data and significant differentiation from existing treatments.

And the phase III emerging one clinical trial showed good efficacy in NSF schools, particularly in negative symptoms of schizophrenia, such as apathy.

<unk> lack of pleasure reduced speech and withdrawal.

It also was well tolerated and demonstrated a favorable safety profile compared to existing therapies.

Overall, these two collaborations vertically and horizontally extended our pipeline.

And we look forward to bringing in more deals for innovative and differentiated products such as these.

And now I will turn the floor over to Dr. Sandra Alan.

Alan.

Thank you Jonathan.

Unknown Attendee: We and our partners had several encouraging data updates for our oncology product candidates in the third quarter, and we anticipate further progress in the fourth quarter. Our partner, Maradi, presented exciting data on etagrassib for colorectal cancer and non-small cell lung cancer at... In the Phase 2 CRSTL1 trial, in patients harboring the KRAS G12C mutation for adagrassive monotherapy, Moradi reported a response rate of 22% and a disease control rate of 87% in 45 colorectal cancer patients treated with single agent adagrassive who received at least two prior lines of systemic anti-cancer therapy.

We and our partners had several encouraging data updates for our oncology product candidates in the third quarter.

And we anticipate further progress in the fourth quarter.

Our partner Marathi presented exciting data on <unk> in colorectal cancer, and non small cell lung cancer at ESMO.

The phase III Crystal one trial in patients harboring the K Ras <unk> mutations for the autographs that monotherapy arm Marathi reported a response rate of 22%.

The disease control rate of 87% and 45 colorectal cancer patients treated with single agent <unk>, who received at least two prior lines of systemic anti cancer therapy.

In 2008, colorectal cancer patients treated with at least two prior lines of systemic anticancer therapies, who received the combination of <unk> and Cetuximab.

Unknown Attendee: In 28 colorectal cancer patients treated with at least two prior lines of systemic anti-cancer therapies who received the combination of adagrassib and situximab, they reported a response rate of 43% and a disease control rate of 100%. In the lung cancer portion of CRISPR-1, which is potentially registration-enabling, Mirati reported an objective response rate of 43% and a disease control rate of 80% for adigrassive monotherapy while demonstrating a safety and tolerability profile consistent with previously reported findings for adigrassive in non-small cell lung cancer patients. Importantly, 98.3% of patients receiving Adegrazib followed treatment with immunotherapy and chemotherapy.

They reported a response rate of 43%.

And the disease control rate of 100%.

In the lung cancer portion of Crystal, one which is potentially registration enabling.

Marathi reported an objective response rate of 43%.

And a disease control rate of 80% for allografts with monotherapy, while demonstrating a safety and tolerability profile consistent with previously reported findings for <unk> in non small cell lung cancer patients.

Importantly, 98, 3% of patients we're sitting at a grassroots following treatment with immunotherapy and chemotherapy.

Allografts it has the potential to be a first in class and best in class K Ras <unk> inhibitor in China.

We plan to join global Phase III studies in second line, plus non small cell lung cancer and second line colorectal cancer in the first half of 2022.

Moving to margin Hudson Ma'am.

His eyes bridging study of the compound in combination with chemotherapy and advanced previously treated her two positive breast cancer met its primary endpoint of median progression free survival.

Find by achievement of at least 50%.

Unknown Attendee: Adagraftiv has the potential to be a first-in-class and best-in-class KRAS G12C inhibitor in China. We plan to join global phase three studies in second line plus non small cell lung cancer and second line colorectal in the first half of 2022. Moving to Margie Tutson, ma'am.

Because the margin effects of map plus chemotherapy in the Sophia study.

The safety profile of <unk>, plus chemotherapy was acceptable and consistent with that seen in the Sophia trial.

Based on these positive results XI lab expects to file a BLA in China for this indication around year end.

Our partner turning point provided positive data updates, but we protect them and advancing them at the ACR NCI RTC Triple meeting.

Unknown Attendee: Zai's bridging study of the compound in combination with chemotherapy in advanced previously treated HER2-positive breast cancer met its primary endpoint of median progression-free survival as defined by achievement of at least 50% of the efficacy of margituximab plus chemotherapy in the SOFIA study. The safety profile of margitoximab plus chemotherapy was acceptable and consistent with that seen in the SOFIA trial. Based on these positive results, Zai Lab expects to file a BLA in China for this syndication around year end.

In addition, <unk> received breakthrough therapy designation by the FDA in the quarter for the treatment of patients with advanced solid tumors that have an <unk> gene fusion.

Which is the second breakthrough therapy designation and seven overall regulatory designation or be protecting it.

We plan to join the global Phase III portion of the shield one study for <unk> in 2022.

For tumor treating fields, we completed enrollment of our pilot phase two clinical trial of tumor treating fields in gastric cancer in China during this quarter.

We plan to joining global phase III pivotal trials in pancreatic cancer, and ovarian cancer and to submit a regulatory filing in malignant pleural mesothelioma.

Beverages map was granted breakthrough therapy designation for first line treatment for patients with FGF or <unk> over expressing and her two negative metastatic and locally advanced gastric and GE J cancers in combination with modified ballpark.

Unknown Attendee: Our partner, Turning Point, provided positive data on unsponsored ADR at the AACR-NCI-EORTC triple meeting. In addition, ricotrexanib received breakthrough therapy designation by the FDA in the quarter for the treatment of patients with advanced solid tumors that have an N-trex gene fusion, which is the second breakthrough therapy designation and seventh overall regulatory designation for reprotectinib. We plan to join the global phase two portion of the SHIELD-1 study for ELSA Vantanib in 2022.

Right.

Amgen initiated a global phase III trial of Derma in gastric cancer in the fourth quarter.

I'm sure you're aware that last Friday, the Cyprus announced that cannot failed to meet its primary endpoint and the intrigue trial.

We were surprised and disappointed with this result and are waiting for further analysis.

We will collaborate with our partner decipher to determine next steps going forward, including a possible combination strategy.

Note that can lock is still the standard of care for fourth line gist patients and addresses major unmet medical needs.

Unknown Attendee: For tumor treating fields, we completed enrollment in our pilot phase two clinical trial of tumor treating fields in gastric cancer in China during this quarter. We plan to join Global Phase III Pimple Trials in pancreatic cancer and ovarian cancer and to submit a regulatory filing in malignant pleural mesothelioma. Bemarituzumab was granted breakthrough therapy designation for first-line treatment for patients with FGFR2B overexpressing and HER2 negative metastatic and locally advanced gastric and GEJ cancers when used in combination with modified Folfax 6.

It remains the only product that has demonstrated significant benefits, including a survival benefit in this setting.

We continue to have a world class Gi cancer portfolio and multiple products in development.

GI cancer as a key area of strength for XI and we are fully committed to working with the gastric cancer medical community in China and globally.

In hematology, we recently announced that we had enrolled the first patient in China in our partner Regeneron global potentially Registrational phase two trial of <unk>.

Next the mab in non Hodgkin's lymphoma.

So many potentially best in class in person class product on schedule. We are very excited about our oncology pipeline of di lab.

Unknown Attendee: Amgen initiated a global phase 3 trial of BEMA in gastric cancer in the fourth quarter. I'm sure you're aware that last Friday, CIFRA announced that Kinloch failed to meet its primary endpoint in the intrigue trial. We were surprised and disappointed by this result and are waiting for further analysis. We will collaborate with our partner, Decipher, to determine next steps going forward, including a possible combination strategy. Note that Kinloch is still the standard of care for fourth-line GIST patients and addresses major unmet medical needs.

And now I will turn the floor over to Harold.

Thank you Alan.

Third quarter brought several very encouraging new development clinical and regulatory in our autoimmune and infectious diseases franchise fees tend to truly advanced our pipeline to the next stage.

Recently, our partner Paces announced topline results from the attack trial. This is a global phase III Registrational trial evaluating the safety and efficacy of <unk> comparing it to colistin in patients with serious infections caused by Acinetobacter <unk>.

Unknown Attendee: It remains the only product that has demonstrated significant benefits, including a survival benefit, in this setting. We continue to have a world-class GI cancer portfolio and multiple products in development. ZI Cancer is a key area of strength for ZI, and we are fully committed to working with the gastric cancer medical community in China and globally. In hematology, we recently announced that we had enrolled the first patient in China in our partner Regeneron's global, potentially registrational, phase two trial, Vodranectomab, for non-Hodgkin's lymphoma.

So back to them doing it back then were so we'll do it for short met the primary endpoint of statistical non inferiority in 28 day all cause mortality.

The patients have mainly pulmonary infections with kind of a pin him resistant acinetobacter by mine no.

Thats crap.

At test of cure there was a statistically higher clinical response with <unk>.

In addition, <unk> met the primary safety objective of this study achieving a statistically significant reduction in deferred tax CCT versus colistin.

Sundar first investigational drug to demonstrate efficacy against crap in a prospective well controlled clinical trial.

Unknown Attendee: Adrenal Hodgkin's lymphoma

Crap infections are amongst the were respectively fixes known to man.

Unknown Attendee: So many potentially best-in-class and first-in-class products on schedule. We're very excited about our oncology pipeline at Zai Lab. Now, I will turn the floor over to Harold.

Safe and effective treatment options are almost nonexistent.

And as a narrow spectrum antibiotics soil door targets crap, Activision preferentially, that's potentially avoiding the collateral damage associated with broad spectrum antibiotics.

Harald Reinhart: Thank you, Alan. The third quarter brought several very encouraging new developments, clinical and regulatory, in our autoimmune and infectious diseases franchise. They stand to truly advance our pipeline to the next stage. Recently, our partner in TASIS announced top-line results from the ATT&CK trial. This is a global phase three registrational trial evaluating the safety and efficacy of sulbactam dulubactam, comparing it to colistin in patients with serious infections caused by hastinidobacter baumannii. Sulbactam dulubactam, or SULDUO for short, met the primary endpoint of statistical non-inferiority in 28-day all-cause mortality.

Look forward to bringing this drug to China.

CBA crab infections are frequently seen in ICU.

And result in high mortality and that Samantha noted we are actively preparing to file suit door with regulators in China.

Moving onto CL 11, two.

This is our internally developed anti IL 17, a novel human <unk> antibody fragment.

We are developing it for topical treatment of plaque psoriasis.

Recently achieved proof of concept with this novel compound and formulation in the first in human Phase one B study.

In this study in Psoriatic target lesions treated for four weeks with $11 two versus placebo in a double blind fashion.

11 O two showed a 45% relative improvement compared to placebo in the local psoriasis area and severity index or <unk>.

Harald Reinhart: The patients had mainly pulmonary infections with carbapenem-resistant acinetobacter baumannii, known as CRAB. At the test of cure, there was a statistically higher clinical response with SULDUR. In addition, SULDUR met the primary safety objective of the study, achieving a statistically significant reduction in nephrotoxicity versus colistin. Sodor is the first investigational drug to demonstrate efficacy against CRAB in a prospective, well-controlled clinical trial.

This clinical benefit was maintained after the end of treatment for a prolonged time observed for up to six weeks.

Two key policy components erythema and scaling showed clear improvement. There was also a reduction in target lesion size with 11, two in contrast to an increase in decent size in the placebo arm.

In a responder analysis 11 O two has higher responder rates compared to placebo at all time points after week one.

And these patients had a full 50% to a greater reduction in local policy score.

Qualify as responders.

The safety and Tolerability profile of $11 two was indistinguishable from placebo pharmacokinetics studies confirmed and lack of systemic absorption, which explains it's benign safety profile.

Harald Reinhart: Crab infections are amongst the worst bacterial infections known to man, and safe and effective treatment options are almost non-existent.

Harald Reinhart: And as a narrow-spectrum antibiotic, Suldur targets crab bacteria preferentially, thus potentially avoiding the collateral damage associated with broad-spectrum antibiotics.

About 125 million cases of psoriasis worldwide and 80% to 90% of these have plaque psoriasis.

70%, 80% of plaque psoriasis patients have mild to moderate disease.

Harald Reinhart: We look forward to bringing this drug to China.

We are developing <unk> two has to first IL 17, directed top two treatments for chronic plaque psoriasis concentrating on those with mild to moderate disease.

Harald Reinhart: Where severe crab infections are frequently seen in ICUs and result in high mortality, we are actively preparing to file a complaint with regulators in China. Moving on to CL1102. This is our internally developed anti-IL-17A novel human VH antibody fragment. We are developing it for the topical treatment of plaque psoriasis. We recently achieved proof-of-concept with this novel compound and formulation in a first-in-human Phase 1b study. In the study, a psoriatic target lesion was treated for four weeks with 1102 versus placebo in a double-blind fashion. 1102 showed a 45% relative improvement compared to placebo in the local psoriasis area severity index, or PASI.

Currently approved IL 17 inhibitor for psoriasis are effective but they are administered subcutaneously and absorbed systemically.

Because they are immune suppressive they carry various warnings and precautions in the labels and are therefore approved for my end sorry for moderate to severe psoriasis only.

On the other hand existing topical treatment for psoriasis and are lacking any efficacy will create safety concerns with long term use.

11 O two has a unique IL 17 inhibitor.

Can be applied topically to the psoriatic plaques without being absorbed systemically.

We look forward to advancing this compound into full development, including Registrational studies.

We also achieved important making inventory progress for TD mode, We see partnered with entertaining.

Our part and the expected decision by the FDA on the regulatory filing of its going to take them on for generalized myasthenia gravis during the fourth quarter of 2021.

And Samantha mentioned, we had a positive meeting with the NPA on F. T demand, which suggests the potential for an accelerated pathway for regulatory approval of Gmg in China.

Harald Reinhart: This clinical benefit was maintained after the end of treatment for a prolonged time, observed for up to...

Harald Reinhart: reserved for up to six weeks. Two key policy components, erythema, and scaling, showed clear improvement. There was also a reduction in target lesion size with 1102 in contrast to an increase in lesion size in the placebo arm. In a responder analysis, 1102 had higher responder rates compared to placebo at all time points after week one, and these patients had a 50% or greater reduction in local policy score. Qualify as a

Subject to U S FDA approval and further discussion.

Do you expect to file the NDA in China.

First half of 2022.

Lastly, we expect approval of Omadacycline as IRA for community acquired bacterial pneumonia and acute active skin and skin structure infections in China by the end of this year.

And now my colleague Tao Fu will speak about progress with our commercial products.

Thank you Harold.

The third quarter marks our continuing progress in ramping up our fleet commercial products all launched within a period of 16 months.

Despite the COVID-19 flare up in certain regions in China, which presented the actress difficulties our commercial team did a great job overcoming these challenges and delivering a strong sales performance.

Harald Reinhart: The safety and tolerability profile of 1102 was indistinguishable from placebo. Pharmacokinetic studies confirmed a lack of systemic absorption, which explains its benign safety profile. There are about 125 million cases of psoriasis worldwide, and 80 to 90% of these have plaque psoriasis. Additionally, 70 to 80% of plaque psoriasis patients have mild to moderate disease. We are developing 1102 as the first IL-17-directed topical treatment for chronic black psoriasis, concentrating on those with mild to moderate disease. Currently, approved IL-17 inhibitors for psoriasis are effective, but they are administered subcutaneously and absorbed systemically.

So July continued to perform well building on our momentum from the last quarter. When the second line ovarian cancer indication was included in the in our deal.

Our team executed two key strategies to grow through jewelry brand.

<unk>.

Our team has been laser focused on increasing hospital listings.

Result of RTL lending.

As of September 30th 2021.

So July was listen in nearly 1100 hospitals in China.

Second our commercial team focused on market penetration to drive pull through by leveraging the jewel of differentiated label as the only PARP inhibitor monotherapy.

All comers in first line ovarian cancer.

By executing these two strategies.

We were able to growth that you lost market share in both revenue and the number of new patients treated.

Harald Reinhart: They carry various warnings and precautions on their labels and are therefore approved for moderate to severe psoriasis only. On the other hand, it seems...

And we plan to carry the momentum into the fourth quarter, when we expect to enter into anarchy at negotiations for first line ovarian cancer.

We're confident that over time.

Unknown Speaker: Unsponsored ADR

Harald Reinhart: 1102 is a unique IL-17 inhibitor that can be applied topically to the psoriatic plaque without being absorbed systemically. We look forward to advancing this compound into full development, including registrational studies. We also achieved important regulatory progress for Efkart-Tigimod, which we partner with Iogenic. As you know, our partner expects a decision by the FDA on the regulatory filing of Efkart-Tigimod for generalized myasthenia gravis during the fourth quarter of 2021. As Amasa mentioned, we had a positive meeting with the NMPA on Efkart-Tige-Maat, which suggests the potential for an accelerated pathway for regulatory approval of GMG in China.

<unk> will be the market leading.

PARP inhibitor in China for ovarian cancer.

Similarly, the launch of <unk> is going well.

During the third quarter, our team focused on continuing to improve market access.

Standing commercial insurance and supplemental insurance coverage for Optum.

Educating targets positions about its significant clinical benefit.

<unk> survival benefits.

Currently <unk> is covered by 'twenty, five municipal or provincial supplemental insurance claims.

The implementation of some of the newly added plans in the fourth quarter presents a good opportunity for us to grow option.

We have also kicked off several important physician education campaigns and.

And plan to establish a GBM patient journey management platform to increase the number of patients treated.

As we noted last quarter, we successfully launched the team law for fourth line Gist in China last may.

Harald Reinhart: Unsponsored ADR Subject to U.S. FDA approval.

And we're still very early in our launch process.

Harald Reinhart: Subject to U.S. FDA approval and further discussion with the NMPA, we expect to file the NDA in China by the first half of 2022. Lastly, we expect approval of Omadacyclin and Osira for community-acquired bacterial pneumonia and acute bacterial skin structure infections in China by the end of this year. And now, my colleague, Tao Fu, will speak about progress with our commercial product. Thank you, Harald.

The key focus of our launch.

Creasing physician awareness and the number of patients treated by leveraging the Invictus trial data.

And shouldn't lock status as the only later line gist treatment, regardless of the mutation status.

Well as the guideline recommendation by the Chinese society of clinical oncology.

In the third quarter. We also received approval for and launch can lock in Taiwan.

The first ever product that is available to all parts of the greater China region. During the first year of launch.

As Alan mentioned earlier.

We're still assessing the impact of it.

In treat result.

Tao Fu: The third quarter marks our continuing progress in ramping up our three commercial products, all launched within a period of 16 months. Despite the COVID-19 flare-up in certain regions in China, which presented access difficulties, our commercial team did a great job overcoming these challenges and delivering a strong sales performance. Xiaojula continued to perform well, building on the momentum from the last quarter when the second line ovarian cancer indication was included in the NRDL.

We're committed to establish kinlaw Alco standard treatment for fourth line Gist based on its compelling product profile extending patient survival.

We will make appropriate adjustments to our commercial strategy.

And now Billy Joel will discuss our third quarter financial results.

Thank you Tal.

We saw continued significant growth a strong performance across our business.

I'll briefly summarize our financial results for the third quarter as well as year to date 2021.

Revenues for the third quarter and year to date installed in 'twenty, one were $43 $1 million and $100 $1 million respectively.

Over the same period last year revenues were $14 $7 million and $33 $9 million respectively.

We're still early commercialization phase, but we're very pleased with the successful launches and sales trajectory of our first three oncology products.

With many more product launches anticipated our commercial platform over time is expected to generate strong growth and considerable operating leverage.

Did you lose sales for third quarter, 2021 were $28 $2 million of $54 $2 million respectively.

Over the same period last year sales were $8 $5 million at $22 $3 million respectively.

Auto sales for the third quarter newspaper publicly one with $10 7 million and $27 $3 million, respectively. Over the same period last year up to sales was $6 million and $11 $4 million respectively.

<unk> sales for third quarter and year to date start 'twenty, one were $4 3 million and $8 $7 million respectively.

Research and development expenses were $55 1 million for the three months ended September 32021.

<unk> to $58 $1 million for the same period in 2020.

The decrease in R&D expenses was primarily attributable to lower upfront payments for new licensing agreements, partially offset by the increase in expenses related to ongoing and newly initiated late stage clinical trials and payroll and payroll related expenses from increased R&D headcount.

Selling general and administrative expenses were $59 million for the three months ended September 32021, compared to $27 $9 million for the same period 2020. The increase was primarily due to payroll and payroll related expenses from increased commercial headcount and expanded commercial activities a dialogue continued to expand it.

Tao Fu: Second, our commercial team focused on market penetration to drive pull-through by leveraging JULA's differentiated label as the only PARP inhibitor monotherapy approved for all comers in first-line ovarian cancer. By executing these two strategies, we were able to grow the Juulus market share in both revenue and the number of new patients treated. And we plan to carry the momentum into the fourth quarter when we expect to enter into RDO negotiations for first-line ovarian cancer. We're confident that over time, Jula will be the market-leading PARP inhibitor in China for ovarian cancer.

Operations throughout greater China.

For the three months ended September 32021 valid reported a net loss of $96 $4 million or a loss per share attributable to common stockholders of $1 <unk>.

Compared to a net loss of $63 7 million or a loss per share attributable to common stockholders was <unk> 84 for the same period in 2020.

As of September 32021, cash and cash equivalents short term investments and restricted cash totaled $1.57 billion compared to $1 $9 billion as of December 31, 2020.

We would now like to turn the call back over to the operator to open up the line for questions.

Operator.

Certainly ladies and gentlemen, we will now begin the question and answer session. If you wish to ask a question. Please press star one on your telephone keypad and wait for you need to be announced if you wish to cancel your request you can press the pound key.

Can you remind me asking questions both Apis to allow everyone a chance.

Tao Fu: Similarly, the launch of Optum is going well. During the third quarter, our team focused on continuing to improve market access by expanding commercial insurance and supplemental insurance coverage for opt-in patients and educating target physicians about its significant clinical benefits, including survival benefits. Currently, Optum is covered by 25 municipal or provincial supplemental insurance plans.

We have the first question is coming from the line of Mike <unk> from Jefferies. Please go ahead.

Hi, Thank you very much and congrats on a great quarter, we had.

Two questions. The first was obviously on the announcement of the Corona transaction. This brings you into a pretty.

Big market opportunity and neurology, but also a complex one can you just comment on how you're thinking about.

Energy and being opportunistic in neurology now going forward.

Tao Fu: The implementation of some of the newly added plans in the fourth quarter presents a good opportunity for us to grow. We have also kicked off several important physician education campaigns and plan to establish a GBM patient journey management platform to increase the number of patients treated. As we noted last quarter, we successfully launched the Kin-Log for 4th Line JIST in China last May, and we're still very early in our launch process.

What that means for business development for U.

And the second question is you.

You had made some nice comments about it.

<unk>.

The <unk> compound can you just remind us about your confidence level in regulatory discussions and the potential faster filing in 2022, and if you could do that that would be that would be huge so would just love to know if you actually think thats possible. Thank you.

Thanks, Mike.

Quite a bit.

Billy.

Several members of our mat.

Tao Fu: The key focus of our launch is increasing physician awareness and the number of patients treated by leveraging the INVICTUS trial data and chin lock status as the only later-line GIST treatment regardless of the new patient status, as well as the guideline recommendation by the Chinese Society of Clinical Oncology. In the third quarter, we also received approval for and launched Kinloch in Taiwan, making it the first ever product that is available to all parts of the greater China region during the first year of law.

Matthew came on sorry about the background noise, we have several of them.

Members of our management team Oswald helped the rest of the traffic for your first question. Okay. Go ahead, our entry into neuroscience.

So I wanted to take this and I'm sure other colleagues to chime in as needed.

Okay.

Sure. Thanks for the question.

I think.

There's actually a similarity.

And Adjacencies for this expansion to neuroscience.

And I like what we have done in the past.

<unk> into sort of severe autoimmune diseases with <unk> going into <unk>.

Hematology.

Tao Fu: As Alan mentioned earlier, we're still assessing the impact of the intrigue results. We're committed to establishing Kinloch as the standard treatment for 4-slime GIST based on its compelling product profile, extending patient survival, and we will make appropriate adjustments to our commercial strategy. Billy Cho will discuss our third quarter financial results. Billy.

With our regeneron collaboration.

There's been a lot of obviously thought and strategizing.

As we go into new areas, but wherever it goes to new areas, there's always similarity.

In this case.

The similarity first of all is that.

Especially with this drug.

Where patients go seek very tiny it's very concentrated.

So there's a very limited number of.

You know in fact, gastric hospitals, where patients get care, there's about a thousand of them.

Unknown Attendee: Thank you, Tao. We saw continued significant growth and strong performance across our business. Today, I'll briefly summarize our financial results for the third quarter as well as year-to-date 2021. Revenues for the third quarter and year to date in 2021 were $43.1 million and $100.1 million, respectively. Over the same period last year, revenues were $14.7 million and $33.9 million.

In addition, the large class three hospitals.

Only a very limited number of them have these psychiatric department within them.

So therefore.

A sales team that's required to.

Commercialized, there's very limited I mean, if you look at.

Some of the currently leading companies in China focus in this area that Salesforce is somewhere between 100 to 300 FTE.

And I think that brings to my second point is that there's adjacency to our current business because.

If you look at.

The first indication.

Unknown Attendee: We're still early in our commercialization phase, but we're very pleased with the successful launches and sales trajectory of our first three oncology products. With many more product launches anticipated, our commercial platform is expected to generate strong growth and considerable operating leverage over time. Digital sales for the third quarter in New York State 2021 were $28.2 million and $64.2 million, respectively. And over the same period last year, digital sales were $8.5 million and $22.3 million, respectively.

Within urology.

D M D.

So before we launch correct see hopefully we already have a commercial team underground.

<unk> <unk>.

And building up retail network in this area.

So you know it's been a very slow process as we go into New York Times, It's a very big market.

Right behind oncology immunology, one of the largest in China and in fact, a very hydraulics here you know double digit card, even though theres very lack of innovative products.

This product being very differentiated.

The offering both on the efficacy side adverse safety side create a differentiation compared to the stand up here today.

Unknown Attendee: Option sales for the third quarter and year-to-date 2021 were $10.7 million and $27.3 million, respectively. And over the same period last year, option sales were $6 million and $11.4 million, respectively. Kinloch sales for the third quarter and year-to-date 2021 were $4.3 million and $8.7 million.

We are very confident about the commercial viability given our presence already in urology.

Given the adjacency of different kind of product and in terms of the future BD effort.

Look when we get into a new area, we would bring an anchor product lifestyle product.

So this is our first product here, we obviously are going to continue to look for assets.

That may be synergistic with this.

Expand our CNS pipeline.

With similar.

They got that.

But certainly it will be on the lock up with us.

And Mike for your second question on that product line.

Yes.

Yeah, Mike for your second question on that part to demand Youre right, we did make announcement.

Unknown Attendee: Research and development expenses were $55.1 million for the three months ended September 30, 2021, compared to $58.1 million for the same period in 2020. The decrease in R&D expenses was primarily attributable to lower upfront payments for new licensing agreements, partially offset by the increase in expenses related to ongoing and newly initiated late-stage clinical trials and payroll and payroll-related expenses from increased R&D. Selling general and administrative expenses were $59 million for the three-month-ended September 30, 2021, compared to $27.9 million for the same period in 2020.

On our third quarter earnings.

We have the potential to submit for approval of diversification by first half of this year and that your question was are pumped this level of debt.

Michael would you like to provide some commentary on this.

Sure thing.

So Michael for the question.

That's where they are we are very optimistic about <unk> potential salary.

Carsten.

For me personally in the first half of <unk> can be two based on our discussion with them.

Okay.

Good.

Thank you.

Yeah. Thanks, Greg.

Sure.

Do you have the next question is coming from the line of Mitchell Moss from Citigroup. Please go ahead.

Uh huh.

Hi, Brian.

Thank you very much for taking the questions I have three.

First I was just wondering about the jaws current market share in second line ovarian in China, and how that market share has been trending since the June we'll watch.

Second I'm curious about the distribution of sales across the 1100 tier one two and three hospitals, whereas it Joe is available.

Unknown Attendee: The increase was primarily due to payroll and payroll-related expenses from increased commercial headcount and expanded commercial activities, as Zai Lab continued to expand its commercial operations throughout Greater China. For the three months ended September 30, 2021, Zai Lab reported a net loss of $96.4 million, or a loss per share attributable to common stockholders of $1.10. Compared to a net loss of $63.7 million, or a loss per share attributable to common stockholders of $0.84, for the same period on the stock market.

Is there a certain tier where youre seeing most sales are the sales evenly distributed across cross hospital tears and finally.

Just curious what are the gating factors for when you will begin to introduce revenue guidance for the June.

So for Optima.

Alright. Thank you for your question.

So.

I'll kick it off on all three and invite other colleagues who joined it needed so that you're the second line market share.

We.

We are not providing specific guidance at this point you can access information like you do in the U S.

Throughout Q D et cetera to get to get views on it what I can share with you. You go is that with the introduction of jewelry in the marketplace.

Unknown Attendee: As of September 30, 2021, cash and cash equivalents, short-term investments, and restricted cash totaled $1.57 billion, compared to $1.19 billion as of December 31, 2021. We would now like to turn the call back over to the operators to open up the line for questions. Operator. Certainly. Ladies and gentlemen, we will now begin the question and answer session. If you wish to ask a question, please press star 1 on your telephone keypad and wait for your name to be announced. If you wish to cancel your request, you can press the pound or hash.

In second line, which is a <unk> product and then of course with first line as the only all comer labeled PARP inhibitor in ovarian cancer clearly, we've seen not only the increasing of the pie of the part penetration, but also our market share within it and that's both within second line.

And also increasingly so in the first line. So we're very optimistic that this trend will continue.

And and and so hopefully that helps you.

And if you could provide additional color as we make further progress and we're very confident that we're really set up here to have a commanding market share position for us that you're willing to bring in your space.

He did not too distant future.

Your second question on the distribution of sales between tier one two or three sort of hospitals.

Hospitals or geographies clearly our initial focus was to really make sure that we penetrate the class three hospitals in the top tier one two cities.

Operator: We would request you to kindly ask two questions of the participants to allow everyone... We have the first question, which is coming from the line of Michael Yee from Jefferies. Please go ahead. Hi. Thank you very much and congratulations on a great quarter. We had two questions. The first was obviously on the announcement of the Karuna transaction.

And you have the benefit that we have the benefit of that legacy with strong execution now with the second one in NRT L. A you know we have nationwide coverage, but the first line is still private pay.

So we're optimistic that we're well positioned.

For for NR deal negotiation on first line as well and that's when you're also going to see not only a chaotic impact of the volume going up but also a broader distribution as well.

And then in terms of any.

Gating factors for revenue guidance.

I guess the.

We're still very much early in our lifecycle.

In terms of commercialization as we noted on the on the call.

But every month that goes by clearly we're getting more momentum.

Michael Jonathan Yee: Can you just remind us about your confidence level in regulatory discussions and the potential faster filing in 2022? And if you could do that, that would be huge. So I'd just love to know if you actually think that's possible.

Sure.

Hard real data.

Insights and our commercial platform continues to.

To execute with strong growth and productivity. So there will be appointed time, but that point in time, it's not at this moment.

Unknown Attendee: Thank you. Thanks, Mike, for the question. This is Billy. We have several members of our management team on. Sorry about the background noise. We have several members of our management team on, so I'll help direct some of the traffic.

Gotcha. Thank you very much.

Thanks Hugo.

The next question comes from the line of Uninstalled Rama from J P. M. Please go ahead.

Hey, guys. Thanks, so much for taking the question.

I've got two quick ones, maybe following up on Mike <unk> question on Neurology, you talked about business development, but will there also be an interim build out of an internal kind of research effort on the neuro side and then second question.

Jonathan J. Wang: For your first question on Carina and our entry into neuroscience, John, why don't you take this, and I'm sure other colleagues can chime in as needed.

Jonathan J. Wang: So thanks for the question, Mike. I think, you know, first of all, there's actually a similarity. Adjacencies for this Expansion to Neuroscience, you know, like what we have done in the past, you know, going into sort of severe autoimmune diseases with EFGAR, going to, you know, hematology, you know, with our Regeneron collaboration, there's been a lot of, obviously, thought and strategizing as we go into new areas. So when we go into new areas, there's always similarities.

I think there was a mention of NR Dl for first line would you have wanted to confirm that 10 locked is also going to be.

And our D L a submission and when those pricing effects could take place in 2022 thanks, so much.

Hey, Paul I'll address your second question and then.

<unk>.

T O for the team on your first question.

So yeah, you heard it right.

First line, so for energen negotiation to Julian first line.

It will be happening, we're well prepared and we're optimistic.

Jonathan J. Wang: In this case, the similarity, first of all, is that, you know, especially with this drug, where patients go to seek care in China, it's very concentrated. So there's a very limited number of psychiatric hospitals where patients go get care. There are about 1,000 of them. And in addition, the large Class 3A hospitals, you know, only a very limited number of them have these psychiatric departments within them.

But we're well prepared for a good outcome, but that's to be determined what you will hear in the public domain will be very similar to last year and previous years, where the drug that made it the puppies and drugs who've made it on the <unk> and accepted will be made public by the NR D. L. A few weeks after.

The negotiation finalized, which you know is happening in the near term and then the most of the companies will be signed an NDA. So you will not hear about the price here.

Jonathan J. Wang: So therefore, you know, the amount of sales team that's required to commercialize this is very limited. I mean, if you look at some of the currently leading companies in China that are focused on this area, their sales force is somewhere between 100 to 300 FTEs. And I think that brings me to my second point, which is that there's adjacency to our current business because, you know, if you look at FCAR, the first indication is within neurology; it's in D&D.

Until until the implementation date, which will be likely January next year early next year this year not like March.

Like you'd start in 'twenty, one where implementation date was March next year is expected to be happening to usual January cycle. So that's the cadence and so there'll be more to come but again, we're optimistic that there.

There will be.

Oh very important drug for many more patients.

And then we will have a dominating our commanding market share positioning the PARP class of ovarian cancer patients now for 10 look we were eligible.

Jonathan J. Wang: So, you know, before we launch CAR-XC, hopefully, we will already have a commercial team on the ground, selling FCAR, and building up the care network in this area. So, you know, it's been a very slow process as we go into neuroscience. It's a very big market. You know, it's right behind oncology and immunology, one of the largest TAs in China, in fact, a very high-growing TA, double-digit growth, even though there's a very lack of innovative products.

We launched the event shift a label in October 20th each year.

Which means we were eligible to be included in the NRT L. A negotiation.

Now too.

Because we have an ability to drive adoption.

And as the only really established itself as a standard of care as Alan mentioned.

In advanced yet and so we have another opportunity next year to do so and so we have good optionality there.

Your first question on neurology, where we're going to build out our internal research capabilities. There as you know and Palm Beach.

Jonathan J. Wang: So, you know, this product being very differentiated, offering both on the efficacy side as well as the safety side, clear differentiation compared to the standard pair today, we are very confident about the commercial viability, given our presence already in New Orleans. Unsponsored ADR

We've been really dedicated energy towards oncology.

Our immunity.

In terms of neurology, we just signed this deal with.

It was hot off the press yesterday, but in terms of building that out I don't know if other cement, though you know Alan Harold if you have additional comments on that or Samantha Harold.

Unknown Speaker: And, Mike, for your second question on FCLAR... Yeah, Mike, for your second question on that partition mod, you're right. We did make an announcement just on our third quarter earnings that, you know, we have the potential to submit for approval in the first location by the first half of next year. And then your question was our confidence level in that. Samantha, would you like to provide some commentary on this? Sure. Thank you, Michael, for the question.

Yes.

Thanks Go ahead go ahead of demand.

Oh go ahead.

Yeah, Hi, Thank you for the question will there be a buildout in neurosciences and the.

<unk>.

This is a big New addition to our current franchise.

Thats require extra work.

Requiring an extended vacation.

It has huge potential.

The big new market for us, but it's not an unknown market because we have had already experienced in the neuroscience world.

As mentioned before we have on the <unk> side at least two programs that are in neurology and that is TMT, obviously in CMP.

Ying Du: Sure. Thank you, Michael, for the question. Definitely, we are very optimistic about the potential to accelerate the approval process and submit the application in the first half of 2022, based on our discussion with the CDC.

So yes, there will be built out in clinical and also in the sales team it will be.

For commercialization in those hospitals in China that has <unk> units.

Yigal Dov Nochomovitz: We have the next question. This is coming from the line of Yigal Nochomovitz from Citigroup. Please go ahead. Hi, Billy and team. Thank you very much for taking the questions. I had three.

Actually is not too much but it does not require large team.

So we think it's worthwhile and.

Mm one point maybe in addition to your question why do we go into this area because we understand the mechanism.

Yigal Dov Nochomovitz: First, I was just wondering about Zajula's current market share in second-line ovarian cancer in China and how that market share has been trending since the Zajula launch. Second, I'm curious about the distribution of sales for Zajula across the 1,100 Tier 1, 2, and 3 hospitals where Zajula is available. Is there a certain tier where you're seeing most sales, or are sales evenly distributed across hospital tiers? And finally, just curious, what are the gating factors for when you will begin to introduce revenue guidance for Zajula and also for Optune?

Well thought out making this an open antagonist in an agonist working on the <unk>.

One in four muscarinic receptor.

And that's a very well established.

Approach is.

It hasn't been really tried it because everybody else is cooked in the areas within the antagonist.

And dopamine and serotonin.

So there's also a lot of data in support of this so with all of this gives us confidence together with the emergent one trial data that this is something we can really sprint flu footprint and fluid.

Thank you.

Yeah, I think Oh, I'm, a palm pilot I think Erika proud of putting those accounts about.

Print out into the area.

That a lot of information.

Unknown Speaker: Alright, Yigal. Thank you for your questions.

In terms of discovery and the palms will not be approved.

Putting our own interests, we still focus on oncology.

Unknown Speaker: I'll kick it off on all three and invite other colleagues to join if needed.

Sure.

Thanks for taking my question.

They've got a problem.

Thank you we have the next question is coming from the line of Jonathan Chang. Please go ahead.

Unknown Speaker: Second-line market share. We are not providing specific guidance at this point.

Hi, guys. Thanks for taking my questions first.

First question can you discuss your trick hence our strategy following the recent.

Unknown Speaker: and access information like you do in the U.S., you know, through IQVIA, et cetera, to get views on it. What I can share with you, Yigal, is that, you know, with the introduction of Zijula in the marketplace, in second line, which is a NRBL reimbursed product, and then, of course, with first line as the only all-comer labeled PARP inhibitor in ovarian cancer, clearly, we've seen not only the growth of the pie of PARP penetration but also our market share within it, and that's both So we're very optimistic that this trend will continue, and so hopefully, that helps you.

Intrigue study results I can provide any color around how youre thinking about potential next steps.

Yes.

Oh, well past that too early.

Great. Thanks, Thanks, very much for the question I think for <unk>.

Next steps at this at this particular point.

We believe very strongly in our world class Gi cancer portfolio and specifically.

For too long.

<unk> in the fourth line setting, which again has been noted in a randomized study showed a significant overall survival benefit. So we'll continue to look.

And worked in that particular area continuing to build upon that in addition of course, we're looking forward to working with the <unk>.

Unknown Speaker: Unsponsored ADR

Unknown Speaker: Based on the distribution of sales in Zijula between Tier 1, 2, and 3 hospitals or geographies, clearly, our initial focus was to really make sure that we penetrated Class 3 hospitals in the top Tier 1, 2 cities, and we have the benefit of that legacy with strong execution. Now with the second line in NRDL, we have nationwide coverage, but the first line is still private pay, and so we're optimistic that we're well positioned for NRDL.

To evaluate the data from the original study and see what sort of opportunities we have moving forward, which potentially could be include combinatoria approaches as well. So that's the that's the approach we'll be taking at this point. Thank you so much for the question.

Got it. Thank you and second question can you provide any color around how the opportune lunar study is progressing are you able to provide any more granular color when the study could readout.

Yeah.

Alan would you like to comment on this one as well.

Unknown Speaker: Unsponsored ADR

Yes I'm good. Thanks for the question. This is something that of course is a study that's been accruing in this round of course by our.

Anupam Rama: Thank you very much. The next question comes from the line of Anupam Rama from JPM. Please go ahead. Hey guys.

Our partner Novocure and we're still.

Anupam Rama: Thanks so much for taking the question. I've got two quick ones. Maybe following up on Mike Yee's question on neurology, you talked about business development, but will there also be an internal build out of some kind of internal research effort on the neuro side? And then there was another question. I think there was a mention of NRDL for Firstline, so I wanted to confirm that Kinloch is also going to be an NRDL submission and when those pricing effects could take place in 2022. Thanks so much.

We're working with them on this and participating in that study and waiting.

Again for the accrual to finish and as you know are.

Given.

The recommendations by the T M a C and.

The follow up for the study has been reduced from 18 months to 12 months. So.

In terms of the minimal follow up so that might provide you with a little bit of guidance as to when we will start to see that potentially after completion of accrual.

Thank you again.

Yes.

Novocure also they say no it's not.

Dave Dave Oni.

The 2022 milestone.

The funnel that has to be that out.

So that'll be decided to go whether it's in the first half second half.

It's going to be.

Unknown Speaker: Hey Anupam, I'll address your second question and then key it up for the team on your first question. So, yeah, you heard it right, you know, first line negotiation, so for energy negotiation, particularly in the first line.

We anticipate modest growth for next year.

Got it thanks for taking the questions.

Thanks Austin.

Yes.

We have the next question is coming from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead.

Oh, thanks, guys.

Just a couple of quick questions first astrazeneca in it.

Our filing documents.

Has noted a patent exploration for one part of that in 2024.

Unknown Speaker: Unsponsored ADR Unsponsored ADR Unsponsored ADR Unsponsored ADR Unsponsored ADR Unsponsored ADR Unsponsored ADR

Just wanted to get a little bit more color on how you guys are assessing the patent landscape.

In China.

Unknown Speaker: Your first question on neurology, where we're going to build out, you know, our internal, you know, research capabilities there. As you know, Anupam, we

Should are you anticipating the entry of when parts of generics in 2024 shortly thereafter.

And if not why.

Why not is there.

Unknown Speaker: As you know, Anupam, we... Unsponsored ADR, and autoimmunity, but in terms of neurology, I mean, we just signed this deal, so it's hot with the press, you know, yesterday, but in terms of building that out, I don't know if other people, you know, Samantha, you know, Al and Harald, if you have additional comments on that, or Samantha or Harald, Go ahead.

Have you assessed the patent landscape and feel that.

When cars is likely to be protracted longer.

If there are generic that are introduced in 2024.

What's your expectation for the evolution of the market.

From that point in time.

And my second question.

It really relates to.

The <unk>.

Expansion in earlier stage opportunity.

Opportune what are you guys doing at this point to prepare for a potential expansion should be that the phase two trial.

Unknown Speaker: Hi, thank you for the question. Will there be a build-out in neurosciences? The answer is yes.

The lunar trial read out positively.

Unknown Speaker: This is a big new addition to our current franchise, so it does require extra work. It will require extra dedication, and it has huge potential. This is a big new market for us, but it's not an unknown market because we have had our experience in the neuroscience world and, as mentioned before, we have on the FKR-TIGEMOD side at least two programs that are in neurology, and that is GMG, obviously, and CIDP. So, yes, there will be a built-out in clinical and also in the sales team.

Basically.

Prepare for uptake in demand.

Okay. Thank you for your questions.

The first one John would you like to take it and then I'll take the second one.

Sure. Thanks for the question Seamus let.

Let me first say that we have a very strong patent position.

Great.

We have a strong composition of matter patent that lost almost to the end of this decade.

And we have a very different set of product. So even if there is generic that comes to the market. After the pause of patent expiry exploration, we have very differentiated assets in particular, where the only asset that has the all comer monotherapy label impress ly.

Unknown Speaker: It will be for commercialization in those hospitals in China that have psychiatric units, which actually is not too much, but it will not require a large team. So we think it's worthwhile. One point, maybe in addition to your question, why do we go into this area? Because we understand the mechanism. This is a well-thought-out mechanism of an antagonist and an agonist working on the M1 and M4 muscarinic receptors. And that's a very well-established mechanism and approach.

And we are rapidly gaining market share as we're being the second line in <unk> as we have.

Is that a product now as we have an idea on negotiations that's currently ongoing.

Successful to get onto the frontline and IDL, we will have even stronger market position, we will solidify.

Our broader label.

Therefore, I think with a different set of product with a strong patent position, we can dominate the market for a very long time with that.

Unknown Speaker: It's one that hasn't really been tried yet because everybody else has looked in other areas with other antagonists that look at dopamine and serotonin. So there's also a lot of data in support of this. So with all this, it gives us confidence, together with the eMERGENT-1 trial data, that this is something we can really sprint for, you know, full presence.

And as Jamie for your second question on syndicated deals.

So off to and obviously, we have it in the market. The second half of last year. Our dedicated commercial team is doing great job covering the top hospitals in option for GBM.

It is about top 250 hospitals and in fact, they covered to neurology two radiotherapy department, we have a dedicated DSS team who.

Continuing to provide patient care and education.

Unknown Speaker: So, yeah, full press forward. Thank you. Yeah, I think, thanks, Anupam. Thanks, Harald. I think Harald brought up a very good point about us branching out into this area with a lot of information. But in terms of discovery, Anupam, we're not interested in building our own research. We still really focus on oncology and opening.

And and and.

He's also been a great job with the supplemental insurance you saw from our earnings release that we have up to about 25, Oh, you know something that insurance plan signed up. So this is going to bode well.

For not only up to really positioning and building awareness for tumor treating fields in the future across indications now next year obviously.

The immuno readout is going to be an important milestone, but ahead of that there's a lot of things we'll be doing. So in addition to other indications and global phase three trials.

Operator: Thank you. We have the next question. This is coming from the line of Jonathan Chang. Please go ahead.

And we just wrapped up a ton of only phase II trial, and we'll have data out for that.

Bye Boston first half of next year.

Jonathan J. Wang: Hi guys, thanks for taking the questions. First question, can you discuss your cancer strategy following the recent intrigue study results? Can you provide any color around how you're thinking about potential?

We're also been preparing to submit a second indication in mesothelioma and as you know it just gives us a strategic opportunity to engage with the lung cancer community head of a possible positive outcome for the lunar trial. So we can really optimize.

Unknown Attendee: We'll pass that to Alan. Great. Thanks. Thanks very much for the question. I think for next steps at this particular point, you know, we believe very strongly in our world-class GI cancer portfolio and specifically for Kinloch in the fourth-line setting, which, again, as has been noted in a randomized study, showed significant overall survival benefits. So we'll continue to look and work in that particular area, and continue to build upon that. In addition, of course, we're looking forward to working with Decipher to evaluate the data from the original study and see what sort of opportunities we have moving forward, which could potentially include combinatorial approaches as well. So that's the approach we'll be taking at this point. Thank you so much for the question. Got it, thanks.

That did that event if it was positive so we remain optimistic on all those fronts and continue to be big believers.

The potential tumor treating fields to serve many many more patients than.

So what we're doing right now.

So thanks for your questions.

I think we can move on to the.

The next question operator.

The next question comes from <unk> Chen from Goldman Sachs. Please go ahead.

Thanks for taking my questions.

Couple of questions on the recent deals number one is on the Bluebird two egfr assets.

Trying to understand a bit more about the two molecules preclinical tox how's the therapeutic window look like and also for their clinical strategy in China.

The third generation Egfr in clothing tech ratio and if some of the domestic.

Unknown Speaker: And second question, can you provide any color around how the Pop-Tune Lunar Study is progressing? Are you able to provide any more granular color when the study is read out? Thank you. Alan, would you like to comment on this one as well?

<unk> is going to potentially becoming the standard of care in China in a circle first line second line setting and some of them also showed a decent.

The framework.

<unk> penetration so well done.

Unknown Attendee: Yes, again, thanks for the question. This is something that, of course, is a study that's been going on and is run, of course, by our partner, Novacure, and we're still working with them on this and participating in that study and waiting, again, for the accrual to finish. And as you know, given the recommendations by the DMFC, the follow-up for the study has been reduced from 18 months to 12 months in terms of the minimal follow-up. So, that might provide you with a little bit of guidance as to when we'll start to see data, potentially after completion of accrual.

B L U $9 45, and a 701, mainly targeting the patient failed the third generation Egfr or if we're trying to move it into earlier life.

I guess, how task study will be inevitable any chance out of the combo could potentially beat that surgery nursing, Jeff right and the survival benefits to patients.

Trying to understand a bit more about your thoughts here and also for.

For car X P. While we understand there is a large population of schizophrenia.

Our ski a little friendly a patient in China.

Six minute plus however, a lot of them actually any of the poor financial condition. So if volatility might be a big challenge.

Unknown Speaker: Yeah, Jonathan, uh, you know, I know that you're also retained now, and I'm not, I don't think that they've only said that that's true.

Unknown Speaker: Unsponsored ADR Got it. Thanks for taking the questions. We have the next question. This is coming from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead. Oh, thanks, guys.

Particularly given available standard of care now are super cheap so.

What could potentially be the pricing strategy here in China, and how we should look at the commercial potential. Thank you.

Thank you for your questions Albert would you like to take this questions around the Egfr.

Seamus Christopher Fernandez: Just a couple of quick questions. First, AstraZeneca, in its filing documents, has noted a patent expiration for LIMPARSA in 2024. Just wanted to get a little bit more color on how you guys are assessing the patent landscape in China. Are you anticipating the entry of generic LIMPARSA in 2024 or shortly thereafter? And if not, why not?

Sure. Thanks Seth.

Thanks, Doug and thanks for the question. So couple as much I think I can probably lump those together. The initial one was more of a sort of the toxicity.

For these two agents, there's wonderful preclinical data that shows exceptional wild type sparing effects and so that's.

Seamus Christopher Fernandez: Have you assessed the patent landscape and feel that LIMPARSA is likely to be protected longer? If there are generics that are introduced in 2024, what's your expectation for the evolution of the market from that point in time? And my second question really relates to the expansion and earlier stage opportunity for Optune. What are you guys doing at this point to prepare for a potential expansion, should the lunar trial read out positively, to basically prepare for uptake and demand?

That is the main cause for toxicity with these types of agents are limited by limiting the effect on the wild type there should be fewer toxic.

Toxicities, such as Dermatologic and diarrhea, So that's one potential advantage and it also what it does is it allows for the potential for combination of these two agents and that's a very key element for this because by combining these two agents based on preclinical data you not only have.

Seamus Christopher Fernandez: Hey Seamus, thank you for your questions. I think the first one is, John. Would you like to take it? And then I'll take the second one.

Limited Wild type, you'll also impact those original.

And mutations.

Jonathan J. Wang: Thanks for the question, Seamus. Let me first say that we have a very strong pattern. Unsponsored ADR, And we have a very differentiated product. So even if there is a generic that comes to the market after Linposit's patent expiration, we have very differentiated assets. In particular, we're the only asset that has the all-comer monotherapy label in first line. And we're rapidly gaining market share, you know, as we're on the second line, NRDL, as we have, you know, a better product.

In Egfr and then also are there.

Distance such as again, the T 790, and the <unk> 797 asked so that allows for coverage that is actually in some way similar to that at time to agree. So and then superior because it also can potentially overcome the escape mechanism of resistance mechanisms. So although the initial.

Study of these agents will be in resistance, because that's a faster path to approval.

Ultimately moving and looking at this combination in the frontline setting is certainly a logical approach and we're confident that along with our partners at blueprint that there is an opportunity there.

Jonathan J. Wang: Now, as we have NRDL negotiations that are currently ongoing, you know, if we're successful in getting on the front line for NRDL, we will have an even stronger market position. We will solidify, you know, our broader label. Therefore, I think with a differentiated product with a strong patent position, we can dominate the market for a very long time with that.

<unk> two.

The superior to progress that we're in this area.

Thank you so much for the question.

Yeah.

In the second quarter.

I'm sorry, there was one last question and they also have.

Excellent blood brain barrier penetration as well so resistance that occurs in the CNS will be overcome by these agents as well.

Thank you sorry.

Thanks Ali.

Do you have for your second question on the car T. Clearly we've done a lot of work around this as we always do for all of our programs, but all of them by the Doe.

Unknown Speaker: And Seamus, for your second question on tumor-treating fields.

Unknown Speaker: So Optune, obviously, we have it in the market since, you know, the second half of last year. Our dedicated, you know, commercial team has been doing a great job covering the top hospitals, you know, in Optune for GBM, there's about 250 hospitals and great coverage for neurology, to radiotherapy departments. We have a dedicated DSS team that, you know, who continue to provide patient care and education. And they've also done a great job with the supplemental insurance each sophomore earns release that we have up to about 25, you know, supplemental insurance plans signed up.

To provide additional color.

Yeah. Thanks for the question Larry.

Look I think first of all.

Cheaper prices due to its pretty much most of the generics.

However, all of the product.

Neil Underwood and in fact, when there is recently a more recent launch product.

In advance of an idea of the price cut was very limited for example in Vega.

5% to 10% price cut to get onto the <unk>.

And its annual treatment cost is about four to 5000 U S dollars, but it's still very largely undifferentiated asset and that doesn't mean, you're not age five.

T category.

So with this product a totally new MLA.

First and best in class attributes.

That addresses not only the positive symptoms of schizophrenia, but more importantly, addressing the negative symptoms, which colony nothing out there does.

With a much better tolerability profile.

Unknown Speaker: So this is going to bode well for not only Optune but also for positioning and building awareness for tumor-treating fields in the future across indications. Now next year, obviously, you know, the lunar readout is going to be an important milestone, but ahead of that, there's a lot of things we'll be doing. So, in addition to other indications and global phase 3 trials, and we just wrapped up a China-only phase 2 trial, and we'll have data out for that, you know, by about the first half of next year, we're also preparing to...

For example, weight gains Qt elongation.

Kind of.

Bad side effect correct T seem to do very well as we believe it is definitely with premium pricing and then you couple that with you know there is about 8 million schizophrenia patients in China. These are chronic usage.

And because of the better Tolerability you can have a much longer potentially.

And then beyond schizophrenia, obviously its potential in dementia related psychosis.

There is nothing currently is approved on the market.

That is a very large market potential or something we should consider as well.

So hopefully this answers your question.

Thank you just a quick follow up here a oh, what is the patent status in China for a car T.

Unknown Speaker: So

Yeah look it's undergoing the prosecution.

Unknown Speaker: Unsponsored ADR So thanks, Jim, for your question. I think we can move on to the... What's the next question, operator? Sure. The next question comes from Ziyi Chen from Goldman Sachs. Please go ahead.

Globally. Its pattern is a pretty broad family of patents two probably major family.

The patents are strong.

No. It includes two API is one of the eight does not approved anywhere in the world. So there's no potential for any off label usage.

Ziyi Chen: Number one is on the Blooper II eGFR assets. I'm trying to understand a bit more about the two molecules' preclinical tox, you know, how the therapeutic window looks like, and also for their clinical strategy in China, because, you know, the third generation eGFR, including TechRacial, and some of the domestic brands are going to potentially become the standard of care in China in the first line, second line setting. And some of them also show decent brain blood barrier penetration.

But overall in the U S. We're looking at the pattern up to 2039.

And we believe we have a good opportunity to get in China as well.

Thank you.

Thank you do you have the next question is coming from Yang Huang from Credit Suisse. Please go ahead.

Thanks.

So I'll have to cross chance first of all why is all of the July so.

Can you quickly comment on kind of what's a rough split.

For the Chula prescription in turmoil.

Around cancer first line maintenance therapy, and the second line maintenance therapy in China, right now just to give us.

Just give us a rough idea of what the grid and are there things.

Ziyi Chen: So, will the BLU 945 and the 701, mainly targeting the patient, fail the third-generation EGFR? Or if we're trying to move it into earlier lines, I guess, how to have the study will be inevitable. Any chance that the combo could potentially beat the third-generation EGFR in terms of survival benefits to patients? You know, trying to understand a bit more about your thoughts here. Unsponsored ADR Unsponsored ADR, Thank you for your questions. Alan, would you like to take the questions around the EGFR? Sure. Thanks, John. Thanks, William.

Our July zing deal negotiation.

It has.

Lots of chassis can be included a full first loss and LAE for first line, including Les ideal, but any of the kind of longer term, what's kind of a rough split between first of all in the second line.

Post Katrina, because its youre no longer in term.

That's my first question and my second question is about our card all PD one strategy since we see.

Our portfolio, we don't have a PD one approved yet.

That's you all were trucks actually our partner doing a combo starting for Suncor, K, Ras and much tucks them out, but they are all dream combo started the combo studies with PD one have seen.

Unknown Attendee: Thanks for the question. So, there are a couple aspects. I think I can probably lump those together.

Great efficacy and safety.

Unknown Attendee: The initial one was more sort of the toxicity. And, you know, for these two agents, there's wonderful preclinical data that shows exceptional wild-type sparing effects. And so, that is the main cause for toxicity with these types of agents. So, by limiting the effects on the wild-type, there should be fewer side effects such as dermalogic and diarrhea. So, that's one potential advantage.

Can you clarify your PD, one or PD L. One come out in support of our strategy in China. Thanks.

Hey, you all and thank you for your questions. So for the digital related question, you'll first of all as you've heard on this call where first lines into law.

We have been selected by negotiation for NR deal inclusion, which would be going into effect early next year.

So that's the secret to that and also like to remind you. We will we are and will be the only all comer first line monotherapy product in the market and it's a very differentiated product profiles. So the inclusion into the inner deal will significantly.

Unknown Attendee: And also, what it does is it allows for the potential for combination of these two agents. And that's a very key element for this because by combining these two agents based on preclinical data, you not only have limited wild-type, but you also impact those original mutations in EGFR and then also resistance, such as, again, T790 and C797F. So, that allows for coverage that is, in some ways, similar to that of Targaryso and then superior because it can also potentially overcome the escape mechanism, and the resistance mechanisms.

Five of our market position and again, we are optimistic on the negotiation and the potential that you would have to be a market share leader in ovarian cancer. So with you know with that.

First line, we've always been saying that the first line.

The indications where really the battle is going to be one and so we continue to have very much caucus around that.

At this time, we're not still getting split between first line second line, you know kind of market share.

And revenue split as well, but just want to remind you young.

We recently launched first line and its the private pay product.

Unknown Attendee: So, although the initial study of these agents will be in resistance because that's a faster path to approval, ultimately moving and looking at this combination in the frontline setting is certainly a logical approach. And we're confident, along with our partners at Blueprint, that there is an opportunity to be superior to Targaryso in this area. Thank you so much for the questions. And Ziyi, for your second question, I'm sorry; there was one last question. They also have excellent blood brain barrier penetration as well, so resistance that occurs in the CNF will be overcome by these agents as well.

And it was up against a reimbursed product, although there was quite a different label so.

We'll try to provide additional color as we go into as we wrap up our first it's really 2021 was our first full.

The year of commercialization. So we're still very much ramping up so I hope you understand in terms of your second question on PD one strategy.

Right in that Oh, we buy it.

Ellen to also comment here.

We have several combos.

And in the future we will have additional what we call. It we're talking to synergies that we expect to realize and that'll be quite proprietary but you're already listed a few that are ongoing K rack. They just had an update take a day or two ago.

Unknown Attendee: Thanks, Alan. And Ziyi, for your second question, of course, clearly.

Unknown Speaker: Unsponsored ADR Thanks for the question. First of all, the cheaper prices are due to it being pretty much mostly generic. However, all the products are on the NRDL, and in fact, when there's a newer launch product, an Unsponsored ADR, that addresses not only the positive symptoms of schizophrenia but, more importantly, addresses the negative symptoms, which currently nothing out there does. And with a much better tolerability profile, you know, for example, weight gain, QT elongation, you know, these kind of bad side effects, CHRT seems to do very well at, we believe it is definitely worth premium pricing. And then you couple that with, you know, there are about 8 million schizophrenia patients in China due to chronic usage. And because of better tolerability, you can have a much longer DOT, potentially.

Any incremental update on the combo for long thought was quite interesting.

March and even into July right PD, one late stage public trials in.

Two very large indication.

Frontline lung and breast.

Breast cancer as well.

And so it's great and it'll be strategic for us to have.

You know not only PD, one, but they have a unencumbered portfolio within immuno oncology to really.

You don't go out there and fully realized.

And synergy opportunities, but Alan do you want to.

Provide any additional color.

Actually I believe you did a great job and I don't have too much more to add other than well continue with the studies that we're doing to establish a.

PD, one rich patent law bad debts as an opportunity for us such that we can then go onto those combinatorial approaches as you mentioned and again.

Jonathan J. Wang: And then beyond schizophrenia, obviously, it has potential for dementia-related psychosis. I mean, when there's currently nothing approved on the market, that is a very large market potential. So I think we should consider this as well. So hopefully, this answers your question. Thank you. Just a quick follow up here. What is the patent status in China for Karakay? Yeah, look, it's undergoing prosecution. You know, globally, its pattern has a pretty broad family pattern. There are two primary major families. The patterns are strong. You know, as you know, it includes two APIs. One of the APIs is not approved anywhere in the world. So there's no potential for any off-label usage.

Hey, Ross, it's certainly an exciting one there'll be other opportunities of course as well along with that in a second generation I O combinations as well so yeah.

Yeah. Thanks, Thanks, very much for the question.

Okay. Thanks.

Thanks, Joe.

Thank you I'm showing no further questions at this time I will now turn the call back over to <unk> CEO, Samantha Du for closing remarks.

Thank you operator.

I want to thank everyone for taking the time to joining us on the call today.

Appreciate your support and look forward to updating you again after the fourth quarter at all.

Later, we will now disconnect the call.

[music].

Jonathan J. Wang: But overall, in the US, you know, we're looking at the pattern up to 2039. And we believe we have a good opportunity here in China as well. Thank you. Thank you. Thank you. We have the next question. This is coming from Yang Huang from Kirk's Music School.

Okay.

[music].

Yes.

[music].

Yes.

Yeah.

Okay.

Yang Huang: Thanks. So I have two questions. First of all, can you quickly comment on kind of what's a rough split for the ZULA prescription in terms of ovarian cancer? First of all, I'm maintaining therapy. And the second line, maintaining therapy in China right now. Just give us some rough ideas would be great.

Uh huh.

Yes.

Okay.

Yes.

[music].

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Tom.

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Yes.

[music].

Yang Huang: And since our ZULA is in the NIDL negotiation, I think it has a larger chance of being included for first line. And if the first line is included in the NIDL, then in the kind of longer term, what's kind of a rough split between first line and second line prescription for the ZULA in the longer term. So that's my first question.

Okay.

Yes.

Okay.

[music].

Yang Huang: And my second question is about our kind of PD-1 strategy. Since, as we see in our portfolio, we don't have PD-1 approved yet, but quite a few of our drugs. Actually, our partners are doing a combo study for the K-RAS and methotrexamine, but they're all doing combo studies, and the combo studies with PD-1 have seen greater efficacy and safety. So can you clarify your PD-1 or PD-L1 kind of development strategy in China? Thank you.

Yes.

[music].

Unknown Speaker: Hey Yang, thank you for your question. So, for the digital-related question...

Unknown Speaker: For the Zijula-related question, first of all, as you've heard on this call, for first-line Zijula, we have been selected in a negotiation for NRDL inclusion, which will go into effect early next year, so it's a season for that. And I'd also like to remind you that we are and will be the only all-comer first-line monotherapy product in the market, and it's a very differentiated product profile, so the inclusion into the NRDL will significantly solidify our market position, and again, we're optimistic about the negotiation and the potential for Zijula to be a market share leader in ovarian cancer.

Yeah.

[music].

Unknown Speaker: Unsponsored ADR

Unknown Speaker: Unsponsored ADR Unsponsored AD

Unknown Speaker: You know, you're right in that, and I'll invite Alan to also comment here, but we have several combos, and in the future, we'll have additional, what we call orthogonal synergies that we expect to realize, and that'll be quite proprietary, but you already listed a few that are ongoing, KRAC, and they just had an update, I think a day or two ago, an incremental update on the combo for lungs, that was quite interesting. MARD, and even Zidula, right, there's PD-1, late-stage combo trials in two very large indications, frontline lung and breast cancer as well, and so it's great, and it'll be strategic for us to have not only PD-1, but to have an unencumbered portfolio within immuno-oncology to really go after and fully realize those orthogonal synergy opportunities, but Alan, do you want to provide any additional color?

Yeah.

[music].

Yes.

[music].

Unknown Speaker: Actually, Billy, you did a great job, and I don't have too much more to add other than that we will continue with the studies that we're doing to establish our PD-1 retrofanilab as an opportunity for use such that we can then go on to those combinatorial approaches, as you mentioned. And again, you know, the KRAS is certainly an exciting one.

Unknown Attendee: There'll be other opportunities, of course, as well, along with that in second-generation I-O combinations as well. So, yeah, thanks very much for the question. Okay, thanks. Thank you. Thank you. I'm showing no further questions at this time. I will now turn the call back over to Zai Lab's CEO, Samantha Jee, for closing remarks. Thank you, Akutu. I want to thank everyone for taking the time to join us online.

Okay.

Yes.

[music].

Ying Du: I want to thank everyone for taking the time to join us on the call today. We appreciate your support and look forward to updating you again after the fourth quarter. Operator, you may now disconnect the call.

Yeah.

[music].

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[music].

Operator: Hello, ladies and gentlemen. Thank you for standing by, and welcome to Zai Lab's third quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode.

Okay.

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Unknown Attendee: Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Mr. Billy Chou, Chief Financial Officer of Zai Lab, who will make introductory comments. Thank you, Operator. Good morning and welcome, everyone.

Okay.

Unknown Attendee: Zai Lab recently issued a press release providing the details of the company's financial results for the third quarter ended September 30, 2021, as well as product highlights and corporate updates. The press release is available in the Investor Relations section of the company's corporate website at ir.zailaboratory.com. Today's call will be led by Dr. Samantha Du, Zai Lab's founder, chairperson, and chief executive officer. She will be joined by Jonathan Wang, Head of Business Development, to discuss our recent collaborations for three new potentially transformative medicines.

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Unknown Attendee: Dr. Alan Sandler, President and Head of Global Development Oncology, who will discuss advances with our Oncology Products Candidate. Dr. Harald Reinhart, CMO, Autoimmune and Infectious Diseases, who will speak about progress we've made in two therapeutic areas.

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Unknown Attendee: This forward-looking statement does not guarantee future performance, and therefore you should not put undue reliance on it. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. I refer you to our SEC filings for a discussion of risk factors that could cause our actual results to differ materially from those discussed today. At this time, it is my pleasure to turn the call over to ZAIDA's Founder, Chairperson, and Chief Executive Officer, Dr. Samantha Duke.

Okay.

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[music].

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Ying Du: Thank you, Billy. Hello, everyone, and thank you all for joining us. On this call, I'll discuss highlights from our third quarter, including two exciting new deals we announced yesterday, and give you the latest update on what we expect to accomplish in the fourth quarter and beyond. We will continue to deliver strong growth and performance across our entire business, making important advances across our innovative portfolio, which we continue to differentiate in terms of the steps and breadth.

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Ying Du: I'm very pleased to share with you that we expanded our product portfolio both vertically and horizontally by establishing partnerships for three new potentially first-in-class or second-in-class products. Our agreement with Brooklyn Medicine for two promising lung cancer compounds, Blue 945 and Blue 701, provides opportunities to further expand our world-class lung cancer franchise. Our deal with Corona Therapeutics allows us to enter a whole new therapeutic area, neuroscience, with an exciting oncoasset CAR-XT. Jonathan Wang will provide additional details about this product in the third quarter of 2021. Zai Lab made significant progress across all fronts, including R&D, BD, regulatory, and commercial.

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Ying Du: We continue to generate strong revenue growth from Zazula, Alp Chung, and Kim Lab. We had a positive meeting with the NNPA on Oscar Tigma, which suggests the potential for an accelerated pathway for regulatory approval for GMG in China. Subject to FDA approval and further discussion with the MMPA, we expect to file the MDA in China by the first half of 2022. We announced exciting data from the ATT&CK clinical trial for sebectum and durabectum, and we will now proceed to prepare regulatory silence. We achieved clinical proof of concept for CL1102, our L17A novel VH antibody fragment for topical treatment.

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Hello, Ladies and gentlemen, thank you for standing by and welcome to <unk> third quarter 2021 financial results Conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer.

Unknown Speaker: [inaudible] Demonstrating proof of concept for GL-1102 is an important milestone for Zai Lab in our effort to discover and develop a pipeline of internally developed Products with Global Rights and to expand to as many locations as possible worldwide. In addition, several of our innovative product candidates have exciting data updates at recent medical meetings. Alan, Harold, and Paul will elaborate on those parts of development in a few minutes. Meanwhile, we continue to expect approval of Muzera for community-acquired bacterial pneumonia, an acute bacterial skin structure infection, by the MMPA in the fourth quarter. We are making progress in preparing a record refining for tumor treating fields in emesophilioma and marked TSMF in breast cancer.

And session and instructions will follow at that time as a reminder, today's call is being recorded.

It is now my pleasure to turn the floor over to Mr. Billy Cho Chief Financial Officer upside lab, who will make introductory comments.

Thank you operator.

Good morning, and welcome everyone.

Dialogue recently issued a press release provided the details of the company's financial results for the third quarter ended September 32021, as well as product highlights and corporate update the.

The press release is available in the Investor Relations section of the company's corporate website at IR Dot by laboratories Dot com.

Today's call will be led by both this method do Dallas founder Chairperson and Chief Executive Officer, She will be joined by Jonathan Wang head of business development to discuss our recent collaboration with three new potentially transformative medicine.

Sandler President and head of global development pathology, who will discuss the dances with our oncology product candidates like apparel, Reinhart CMO autoimmune and infectious diseases, who will speak about progress. We've made in two therapeutic areas pulp Hu Chief strategy Officer, who will discuss the performance of our market products and I will conclude with comments.

Ying Du: And we expect to enroll patients in China for numerous global clinical trials over the next several quarters. We now have 28 globally innovative assets in our pipeline, and the quality, depth, and breadth of our pipeline continue to grow from strength to strength. 13 products are in late stage development, of which five have already been approved in the U.S., and four have received FDA breakthrough therapy designation. In addition, our Green Pipeline includes 11 early stage programs with worldwide rights, including three in global clinical trials and one that achieves poor concept and is advancing into full development.

On our financial results in the quarter will all be available to answer questions. During the Q&A portion of the call.

As a reminder.

Forward looking statements are not guarantees of future performance and therefore, you should not put undue reliance upon them.

These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect I refer you to our SEC filings for a discussion of risk factors that could cause our actual results to differ materially from those discussed today at this time. It is my pleasure to turn the call over to Guy, that's founder Chairperson and Chief Executive Officer to talk to somebody to do it.

Ying Du: We have had a very productive year so far in 2021. We expect our fourth quarter of 2022 to be rich in milestones to unlock significant value in our business. With that, I'll now ask Jonathan to speak about our two collaborations.

Thank you Daniel Hello, everyone and thank you all for joining us.

On this call I'll discuss highlights from our third quarter.

Flipping to exciting new tool we have now.

I'll give you the latest update what they expect to accomplish in the fourth quarter and the P. M.

Jonathan J. Wang: Yesterday, we announced two strategic collaborations that further strengthen and broaden our pipeline. Agreement with Blueprint, planning for the two next-generation EGFI inhibitors. Blue 945 and Blue 701 will significantly strengthen our established lung cancer franchise and precision medicine portfolio, one of our most important focus areas where we have multiple late stage assets that are complementary to each other. You may know that lung cancer is the most commonly diagnosed cancer type and is the leading cause of cancer death in China. The annual incidence of lung cancer in China is more than 800,000 cases, of which non-small cell lung cancer accounts for approximately 85%.

The contingent with the name or somehow and postpone them.

Across our entire business.

We made important advances across our innovative portfolio, which we continue to differentiate in terms of the best in class.

I'm very pleased to share with you that the bundle.

Our product portfolio, both vertically and horizontally.

Publishing partnerships.

The deal potentially first in class.

Our best in class product.

Our Cleveland with breakthrough medicine.

Two promising long types of compounds.

Nine five and closed several one present an opportunity to further expand our walkoff lung cancer franchise.

Our deal with <unk> Therapeutics allows us to enter a whole new therapeutic areas.

Jonathan J. Wang: EGFR mutations are more common in China than in the United States, occurring in 40-50% of non-smart cell lung cancer patients, and these two compounds target the largest subpopulation in lung cancer for children. Third-generation EGFR TTIs, such as Ozymetanib, are commonly prescribed and have emerged as a center of care for the first line setting. However, resistance inevitably emerges, leading to disease progression.

Fun and exciting classic car T jumped from one will provide additional details about this product.

In the third quarter of kidney to pull one.

Satellite meet with significant progress across all fronts.

R&D beaten regulatory and commercial.

We continue to generate strong revenue growth from the rollout of tone on the King lock.

We had a positive meeting with the NPA.

Pick them up.

I guess the potential accelerant possible from that particular role for TNT in China.

Jonathan J. Wang: There are no approved therapies for patients with disease progression following third-generation EGFR treatment. These two compounds from Blueprint are potentially first and or best in class fourth generation EGFR inhibitors. And together with our other lung cancer products, we'll enable Zai to cover nearly all the different patient populations for this deadly disease. GLUTEN945 is a potential first-in-class inhibitor of triple mutant EGFR, covering either the activating LA58R or exon 19 deletion mutations, combined with the acquired C790N and C797F mutations.

Subject to FDA approval and further discussion with an NPA.

To file the NDA in China that first half of 2022.

And now exciting data from the.

Clinical trials.

The bathroom drove back to them.

We will now proceed to prepare regulatory filings.

We achieved clinical proof of concept with C L.

<unk>, our IL 17, a novel G H M with the recycling.

Well topical treatment.

Now to multi well pad.

Demonstrating proof of concept for T. L. A doesn't hold true with many important milestones both by lab another aspect to this.

Cover and develop a pipeline of internally developed.

Jonathan J. Wang: It is potent and has demonstrated high wild-type EGFR selectivity to enable its use in combination, and it has shown anti-tumour activity both alone and in combination with RTD preclinical activity. They entered a Phase 1-2 clinical trial earlier this year. B701 is a selective EGFR double mutant, providing potential best-in-class coverage of activating EGFR mutations, plus coverage of the major on-target resistance mutations for autism, which is the C797S mutation. It is also highly potent and crosses the blood-brain barrier, which is important because in EGFR-mutated non-small cell lung cancer patients with baseline brain metastases, up to 40% of disease progression involves CNS metastases.

Problem with global rights.

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Okay. So is it possible worldwide.

In addition, several of our major products.

I didn't think I was upbeat.

Recent medical meeting.

Island, Harold and Paul.

On both parts of development in a few minutes.

We continue to expect approval after that.

Uh huh, Okay, NPA acquired bacterial pneumonia and acute bacterial skin and skin structure infection, and then pool in the fourth quarter.

We are making progress in preparing our regulatory filing for tumor treating fields.

The CBL mall Mod pizza math breast cancer.

And we expect to roll patients in China.

Numerous global clinical trials over the next several quarters.

We now have 28 globally.

We're not a platform.

Quality depth and breadth of our pipeline continues to come from since the spin.

13 product okay.

Both developments.

Jonathan J. Wang: Blue 701 is expected to begin phase one clinical trials before the end of the year. The development strategy for these two compounds is either as monotherapy or in combination together or with other agents to overcome or prevent on-target resistance across multiple lines of treatment. In addition, this collaboration enables opportunities to combine Blue 945 or Blue 701 with other Zai Lab lung cancer drug candidates to address the octagonal resistance mutation. Yesterday, we also announced an exciting collaboration with Karuna to exclusively develop and commercialize CarXT for Schizophrenia and Dementia-Related Psychosis in Greater China.

Reach five have already been approved in July.

So how can you hear me.

The breakthrough designation.

In addition, our gaming platform.

11 early stage programs, whereby rights, including three in global clinical trials and one of the key port concept.

1941.

Right.

We have had a very productive year, so far for 2021.

Our fourth quarter, and 2022 to be reaching milestones to unlock significant value.

With that I'll now ask something to speak about our true collaboration Jonathan.

Thank you Samantha.

So as I mentioned, yes.

Yesterday, we announced two strategic collaborations that further strengthen and broaden our pipeline.

Our agreement with blueprint honoring the two next generation Egfr inhibitors.

Jonathan J. Wang: We already have several products in urology, including F-carotid demands. So this is an adjacent expansion for Zai, and CAR-XT can leverage our existing infrastructure to create synergy. S. Scott Gates, Zai Lab, and Anchor Asset in Autoimmune Disorders. We believe CAR XP will do the same for us in Europe.

<unk> 945, and Blu 701 will significantly strengthen our established lung cancer franchise and precision medicine portfolio. One of our most important focus area, where we have multiple late stage assets.

Complementary with each other.

You'll recall that lung cancer is the most commonly diagnosed cancer type one of the leading cause of cancer death in China.

Yeah.

Of lung cancer in China is more than 800000 places.

Of which non small cell lung cancer accounts for approximately 85%.

Jonathan J. Wang: It is a late stage asset with first in class potential in a disease area with a large patient population and significant market and medical needs. There are an estimated 8 million schizophrenia patients in China. The target population for dementia-related psychosis in China is about 2 million patients.

Egfr mutations.

More common in China, United States.

40% to 50% of non small cell lung cancer patients.

And these two compounds private the largest subpopulation lung cancer for chart.

First generation Egfr.

Okay.

Jonathan J. Wang: Power XT is a phase 3 asset with strong phase 2 data and significant differentiation from existing treatments. In the Phase 2, Emerging 1 clinical trial, it showed good efficacy in pan-SS scores, particularly in negative symptoms of schizophrenia, such as apathy, lethargy, lack of pleasure, reduced speech, and withdrawal. It also was well tolerated and demonstrated a favorable safety profile compared to existing therapies. Overall, these two collaborations vertically and horizontally extended our pipeline, and we look forward to bringing in more deals for innovative and differentiated products such as these. And now, I'll turn the floor over to Dr. Thangla. Alan.

Ed.

Emily prescribes and have emerged as the standard of care for the first line setting.

However, resistance inevitably emerges leading to disease progression.

There are no approved therapy for patients with disease progression following third generation Egfr treatment.

These two compounds from Blue cranes are potentially first and go best in class fourth generation Egfr inhibitors.

And together with our other lung cancer product will enable desire to cover nearly all of the different patient population for this deadly disease.

<unk> is a potential first in class inhibitor of Triple mutant Egfr operating either be activating L. A five eight.

Or exon 19 deletion mutation.

Bind with the acquired seven nine and 797 patients.

It is potent and has demonstrated high wildfire egfr selectivity to enable its use in combination.

And it has shown antitumor activity both alone and in combination with all the pre clinically.

Unknown Attendee: Thank you, Jonathan. We and our partners had several encouraging data updates for our oncology product candidates in the third quarter, and we anticipate further progress in the fourth quarter. Our partner, Maradi, presented exciting data on etagrassib and colorectal cancer and non-small cell lung cancer at... In the Phase 2, CRYSTAL1 trial, in patients harboring the KRAS G12C mutation who received Adagrassive Monotherapy, Moradi reported a response rate of 22% and a disease control rate of 87% in 45 colorectal cancer patients. Patients treated with single agent etagrassin have received at least two prior lines of systemic anti-cancer therapy.

They entered a phase one two clinical trial earlier this year.

Blu 701 is a selective egfr double mutant inhibitor, providing potential best in class coverage of activating Egfr mutation.

But coverage of the major on target resistance mutation.

Which is the 797 S mutation.

It is also a highly potent and crosses the blood brain barrier.

Because you get part of it is non small cell lung cancer patients with baseline brain metastasis.

40% of disease progression.

Both CNS metastases.

Blu 701 is expected to begin phase one clinical trials before the end of the year.

The development strategy you put these two compounds is either as monotherapy or in combination together with other agents.

Hum or prevent on private resistant across multiple lines of treatment.

Tradition this.

This collaboration enables opportunity the combined blue non call five or Blu 701, with other dry lab lung cancer drug candidate.

Unknown Attendee: In 28 colorectal cancer patients treated with at least two prior lines of systemic anti-cancer therapies who received the combination of adagrassive and cituximab, they reported a response rate of 43% and a disease control rate of 100%. In the lung cancer portion of CRISPR-1, which is potentially registration-enabled, Mirati reported an objective response rate of 43% and a disease control rate of 80% for adigrassive monotherapy while demonstrating a safety and tolerability profile consistent with previously reported findings for adigrassive in non-small cell lung cancer patients. Importantly, 98.3% of patients receiving adegrassib have been treated with immunotherapy and chemotherapy.

Avocado resistance mutation.

Yesterday, we also announced an exciting collaboration with Corona exclusively developed and commercialized car T.

Or it's a premia in dementia related psychosis and go ahead of time.

We already have several product neurology, including aircraft demand.

This is an adjacent expansion per die and car X P can leverage our existing infrastructure to create synergy.

It's got great dialogue and anchor asset in order to meet disorders. We believe correct. He will do the same for us of your clients.

It is a late stage assets with best in class potential disease area with a large patient population and significant unmet medical needs.

There are an estimated 8 million schizophrenia patients in China, and the target population for dementia related psychosis in China is about 2 million patients.

Unknown Attendee: Adagrafted has the potential to be a first-in-class and best-in-class KRAS G12C inhibitor in China. We plan to join global phase 3 studies in second-line plus non-small cell lung cancer and second-line colorectal cancer in the first half of 2022. Moving to Marja Tutsman.

Correct.

A phase III asset with strong phase II data and significant differentiation from existing treatments.

And the phase two emerging one clinical trial showed good efficacy in Penn S. F scores, particularly in negative symptoms of schizophrenia, such as apathy.

Unknown Attendee: Zai's bridging study of the compound in combination with chemotherapy in advanced previously treated HER2-positive breast cancer met its primary endpoint of median progression-free survival as defined by achievement of at least 50% of the efficacy of margituximab plus chemotherapy in the SOFIA study. The safety profile of margituximab plus chemotherapy was acceptable and consistent with that seen in the SOFIA trial. Based on these positive results, Zai Lab expects to file a BLA in China for this syndication around year end.

<unk> lack of pleasure reduced speech and withdrawal.

It also was well tolerated and demonstrated a favorable safety profile compared to existing therapies.

Overall, these two collaborations vertically and horizontally extended our pipeline.

And we look forward to bringing in more deals for innovative and differentiated products such as these.

And now I will turn the floor over to Dr. Sandra Alan.

Alan.

Thank you Jonathan.

We and our partners had several encouraging data updates for our oncology product candidates in the third quarter.

And we anticipate further progress in the fourth quarter.

Unknown Attendee: Our partner Turning Point provided positive data for Rupert Truxtunib and Alvaro Vance at the AACR-NCI-EORTC triple meeting. In addition, ricotrectinib received breakthrough therapy designation by the FDA in the quarter for the treatment of patients with advanced solid tumors that have an N-TREK gene fusion, which is the second breakthrough therapy designation and seventh overall regulatory designation for reprotectinib We plan to join the global phase two portion of the SHIELD-1 study for ELSA Vantanib in 2022.

Our partner Marathi presented exciting data on EDA grass it in colorectal cancer and non small cell lung cancer at ESMO.

The phase III Crystal one trial in patients harboring the K Ras G 12 C mutation for the attic grass mono therapy arm Marathi reported a response rate of 22% and a disease control rate of 87% and 45 colorectal cancer patients treated with single agent <unk>.

Grasser, who received at least two prior lines of systemic anti cancer therapy.

In 2008, colorectal cancer patients treated with at least two prior lines of systemic anticancer therapies, who received the combination of allograft and cetuximab. They.

Unknown Attendee: For tumor treating fields, we completed enrollment in our pilot phase two clinical trial of tumor treating fields in gastric cancer in China during this quarter. We plan to join global phase three pimple trials in pancreatic cancer and ovarian cancer and to submit a regulatory filing in malignant pleural mesothelioma. Vemurituzumab was granted breakthrough therapy designation for first-line treatment for patients with FGFR2B overexpressing and HER2 negative metastatic and locally advanced gastric and GEJ cancers in combination with modified FOLPOX 6.

They reported a response rate of 43%.

And the disease control rate of 100%.

In the lung cancer portion of Crystal, one which is potentially registration enabling.

Marathi reported an objective response rate of 43%.

And a disease control rate of 80% for allografts with monotherapy.

Demonstrating a safety and Tolerability profile consistent with previously reported findings for <unk> in non small cell lung cancer patients.

Importantly, 98, 3% of patients receiving allografts following treatment with immunotherapy.

Unknown Attendee: Amgen initiated a global phase three trial of BEMA in gastric cancer in the fourth quarter. I'm sure you're aware that last Friday the CIFRA announced that Kinloch failed to meet its primary endpoint in the intrigue trial.

<unk> chemotherapy.

Allografts it has the potential to be a first in class and best in class K Ras <unk> inhibitor in China.

We plan to join global Phase III studies in second line non small cell lung cancer and second line colorectal cancer in the first half of 2022.

Unknown Attendee: We were surprised and disappointed by this result and are waiting for further analysis, and will collaborate with our partner, Decipher, to determine next steps going forward, including a possible combination strategy. Note that Kinloch is still the standard of care for fourth-line GIST patients and addresses major unmet medical needs. It remains the only product that has demonstrated significant benefits, including a survival benefit, in this study. They continue to have a world-class GI cancer portfolio and multiple products in development.

Moving to margins Hudson Ma'am.

<unk> bridging study of the compound in combination with chemotherapy and advanced previously treated her two positive breast cancer met its primary endpoint of median progression free survival.

Find by achievement of at least 50% of the App.

Because the margin effects of map plus chemotherapy in the Sophia study.

The safety profile of <unk>, plus chemotherapy was acceptable and consistent with that seen in the Sophia trial.

Unknown Attendee: ZI Cancer is a key area of strength for ZI, and we are fully committed to working with the gastric cancer medical community in China and globally. In hematology, we recently announced that we had enrolled the first patient in China in our partner Regeneron's global, potentially registrational, phase two trial, Vodranectomab, for non-Hodgkin's lymphoma. So many potentially best-in-class and first-in-class products on schedule. We're very excited about our oncology pipeline at Zai Lab. And now, I will turn the floor over to Harold.

Based on these positive results XI lab expects to file a BLA in China for this indication around year end.

Our partner turning point provided positive data update for <unk> and advancing that.

At the ACR NCI.

RTC Triple meeting.

In addition, we've got.

<unk> received breakthrough therapy designation by the FDA in the quarter for the treatment of patients with advanced solid tumors that have an <unk> gene fusion.

Which is the second breakthrough therapy designation and seven overall regulatory designation are we protecting it.

We plan to join the global Phase III portion of the shield one study for <unk> in 2022.

Harald Reinhart: Thank you, Alan. The third quarter brought several very encouraging new developments, clinical and regulatory, in our autoimmune and infectious diseases franchise. They stand to truly advance our pipeline to the next stage. Recently, our partner in TASIS announced top-line results from the ATT&CK trial. This is a global phase three registrational trial evaluating the safety and efficacy of sulbactam dulubactam, comparing it to colistin in patients with serious infections caused by hastenidobacter baumannii. Sulbactam dulubactam, or SULDUO for short, met the primary endpoint of statistical non-inferiority in 28-day all-cause mortality.

For tumor treating fields, we completed enrollment of our pilot phase two clinical trial of tumor treating fields in gastric cancer in China during this quarter.

We plan to join global Phase III pivotal trials in pain.

Riyadh of cancer, and ovarian cancer and to submit a regulatory filing in malignant pleural mesothelioma.

Beverages map was granted breakthrough therapy designation for first line treatment for patients with FGF are to be over expressing and her two negative metastatic and locally advanced gastric and J J cancers.

Combination with modified ballpark six.

And Jen initiated a global phase III trial of Derma in gastric cancer in the fourth quarter.

I'm sure you're aware that last Friday, the Cyprus announced that cannot failed to meet its primary endpoint in the entry trial.

Harald Reinhart: The patients had mainly pulmonary infections with carbapenem-resistant acinetobacter baumannii, known as CRAB. At the test of cure, there was a statistically higher clinical response with Suldur. In addition, Suldur met the primary safety objective of the study, achieving a statistically significant reduction in nephrotoxicity versus colistin. Sodor is the first investigational drug to demonstrate efficacy against CRAB in a prospective, well-controlled clinical trial.

We were surprised and disappointed with this result and are waiting for further analysis.

We will collaborate with our partner decipher to determine next steps going forward, including a possible combination strategy.

Note that can lock is still the standard of care for fourth line gist patients and addresses major unmet medical need.

It remains the only product that has demonstrated significant benefits, including a survival benefit in this setting.

We continue to have a world class Gi cancer portfolio and multiple products in development.

Harald Reinhart: Crab infections are amongst the worst bacterial infections known to man, and safe and effective treatment options are almost non-existent.

Chi I cancer as a key area of strength for XI and we are fully committed to working with the gastric cancer medical community in China and globally.

Harald Reinhart: And as a narrow-spectrum antibiotic, Suldur targets crab bacteria preferentially, thus potentially avoiding the collateral damage associated with broad-spectrum antibiotics. We look forward to bringing this drug to China, where severe crab infections are frequently seen in ICUs and result in high mortality. We are actively preparing to file a request with regulators in China.

In hematology.

We announced that we had enrolled the first patient in China in our partner Regeneron global potentially Registrational phase II trial of <unk> in non Hodgkin's lymphoma.

So many potentially best in class and first in class product on schedule. We are very excited about our oncology pipeline of di lab.

And now I will turn the floor over to Harold.

Thank you Allen third quarter brought several very encouraging new development clinical and regulatory in our autoimmune and infectious diseases franchise, they stand to truly Atlanta pipeline to the next stage.

Harald Reinhart: Moving on to CL1102. This is our internally developed anti-IL-17A novel human VH antibody fragment. We are developing it for topical treatment of plaque psoriasis, and we recently achieved proof of concept with this novel compound and formulation in a first-in-human phase 1b study. In the study, a psoriatic target lesion was treated for four weeks with 1102 versus placebo in a double-blind fashion. 1102 showed a 45% relative improvement compared to placebo in the local psoriasis area severity index, or PASI. This clinical benefit was maintained after the end of treatment for a prolonged time, observed for up to six months.

Recently, our partner paces to announce top line results from the attack trial. This is a global phase III Registrational trial evaluating the safety and efficacy of <unk> comparing it to colistin in patients with serious infections caused by acinetobacter by Miami.

So back to I'm doing a back 10, or so we'll do it for short.

The primary endpoint of statistical non inferiority in 28 day all cause mortality.

The patients have mainly pulmonary infections with kind of a pin him resistant acinetobacter by mine Yanai <unk> crap.

At test of cure there was a statistically higher clinical response with <unk> and.

In addition, <unk> met the primary safety objective of the study achieving a statistically significant reduction in deferred tax CCT versus colistin.

Harald Reinhart: Two key policy components, erythema, and scaling, showed clear improvement. There was also a reduction in target lesion size with 1102 in contrast to an increase in lesion size in the placebo arms. In a responder analysis, 1102 had higher responder rates compared to placebo at all time points after week one, and these patients had a 50% or greater reduction in local policy score. Qualify as responder

Sundar, it's the first investigational drug to demonstrate efficacy against crap in a prospective well controlled clinical trial.

Crap infections are amongst the were respectively fixes known to man.

Safe and effective treatment options are almost nonexistent.

And as a narrow spectrum antibiotics sewell door targets crap activity to preferentially that's potentially avoiding the collateral damage associated with broad spectrum antibiotics.

Look forward to bringing this drug to China, where CBA crab infections are frequently seen in ICU.

Harald Reinhart: The safety and tolerability profile of 11.0.2 was indistinguishable from placebo. Pharmacokinetic studies confirmed a lack of systemic absorption, which explains its benign safety profile.

And result in high mortality and as Samantha noted we are actively preparing to file soon door with regulators in China.

Moving on to see how 11 out too.

<unk> is our internally developed anti IL 17, a novel human <unk> antibody fragment.

We are developing it for topical treatment of plaque psoriasis.

Harald Reinhart: There are about 125 million cases of psoriasis worldwide, and 80 to 90% of these have plaque psoriasis. Additionally, 70 to 80% of plaque psoriasis patients have mild to moderate disease. We are developing 1102 as the first IL-17-directed topical treatment for chronic glaucoma psoriasis, concentrating on those with mild to moderate disease. Currently, approved IL-17 inhibitors for psoriasis are effective, but they are administered subcutaneously and absorbed systemically.

Recently achieved proof of concept with this novel compound and formulation in the first in human Phase one B study.

In this study in Psoriatic target lesions treated for four weeks with $11 two versus placebo in a double blind fashion.

11 O two showed a 45% relative improvement compared to placebo in the local psoriasis area and severity index or policy.

This clinical benefit was maintained after the end of treatment for a prolonged time series for up to six weeks.

Two key policy components erythema and scaling showed clear improvement. There was also a reduction in target lesion size with $11. Two in contrast to an increase in lesion size in the placebo arm.

Harald Reinhart: Because they are immunosuppressive, they carry various warnings.

Harald Reinhart: and are therefore approved for mild, sorry, moderate to severe psoriasis only. On the other hand, existing topical treatments for psoriasis are lacking in efficacy or create safety concerns with long-term use. 1102 is a unique IL-17 inhibitor that can be applied topically to the psoriatic plaque without being absorbed systemically.

In a responder analysis 11 O two had higher responder rates compared to placebo at all time points after week one.

And these patients had a 50% or greater reduction in local policy score.

Quantify as responders.

The safety and Tolerability profile of $11 two was indistinguishable from placebo pharmacokinetic studies confirmed and lack of systemic absorption, which explains it's benign safety profile.

Harald Reinhart: We look forward to advancing this compound into full development, including registrational studies. We have also achieved important regulatory progress for EFCA-TGMOD, which we are developing with Hygienics. As you know, our partner expects a decision by the FDA on the regulatory filing of EFCA-TGMOD for generalized myasthenia gravis during the fourth quarter of 2021. As Samantha mentioned, we had a positive meeting with the NMPA on Efghati Ghamat, which suggests the potential for an accelerated pathway for regulatory approval of GMG in

About 125 million cases of psoriasis worldwide and 80% to 90% of these have plaque psoriasis.

70, <unk> hundred 80% of plaque psoriasis patients have mild to moderate disease.

We are developing <unk> two has to first IL 17, directed topical treatment for chronic plaque psoriasis concentrating on those with mild to moderate disease.

Currently approved IL 17 inhibitor for psoriasis are effective but they are administered subcutaneously and absorbed systemically.

Because the immune suppressive they carry various warnings and precautions in the label rules and has therefore approved for my end sorry for moderate to severe psoriasis only.

On the other hand existing topical treatments for psoriasis are lacking any efficacy will create safety concerns with long term use.

Unknown Speaker: [inaudible] Subject to U.S. FDA approval.

Unknown Speaker: Subject to U.S. FDA approval and further discussion with the NMPA, we expect to file the NDA in China by the first half of 2022. Lastly, we expect approval of Omadacyclin and Osira for community-acquired bacterial pneumonia and acute bacterial skin structure infections in China by the end of this year. And now, my colleague Taufu will speak about progress with our commercial product. Thank you, Harald.

<unk> two has a unique IL 17 inhibitor.

Can be applied topically to the psoriatic plaques without being absorbed systemically.

We look forward to advancing this compound into full development, including Registrational studies.

We also achieved important making inventory progress for if Greg T demand, we see partnered with entertaining.

Our partner <unk> expect a decision by the FDA on the regulatory filing of expected demand for generalized myasthenia gravis during the fourth quarter of 2021.

Tao Fu: The third quarter marks our continuing progress in ramping up our three commercial products, all launched within a period of 16 months. Despite the COVID-19 flare-up in certain regions in China, which presented access difficulties, our commercial team did a great job overcoming these challenges and delivering a strong sales performance. Sergiula continued to perform well, building on the momentum from the last quarter when the second line ovarian cancer indication was included in the NRDL.

As Samantha mentioned, we had a positive meeting with the NPA on F. T demand, which suggests the potential for an accelerated pathway for regulatory approval of Gmg in China.

Subject to U S. FDA approval interesting discussion within an NPA do you expect to file the NDA in China.

First half of 2022.

Lastly, we expect approval of Omadacycline in Syros for community acquired bacterial pneumonia and acute bacterial skin and skin structure infections in China by the end of this year.

And now my colleague Tao Fu would speak about progress with our commercial products.

Thank you Harold.

The third quarter marks our continuing progress in ramping up our fleet commercial products all launched within a period of 16 months.

Tao Fu: Our team executed two key strategies to grow the Dojula brand. First, our team has been laser focused on increasing hospital listings as a result of our NRDL lens. As of September 30th, 2021, the jula was listed in nearly 1,100 hospitals in China. Second, our commercial team focused on market penetration to drive pull-through by leveraging the Juleps differentiated label as the only PARP inhibitor monotherapy approved for all comers in first-line ovarian cancer. By executing these two strategies, we were able to grow the Juulus market share in both revenue and the number of new patients treated We're confident that over time, Jula will be the market-beating PARP inhibitor in China for ovarian cancer.

So July continued to perform well.

Building on our momentum from the last quarter when the second line ovarian cancer indication was included in the <unk> deal.

Our team executed two key strategies to grow through July brand.

First.

Our team has been laser focused on increasing hospital listings.

All of our <unk> lending.

As of September 30th 2021.

So July was lifted in nearly 1100 hospitals in China.

Second our commercial team focused on market penetration to drive pull through by leveraging the jewelry differentiated label as the only PARP inhibitor monotherapy approved for all comers in first line ovarian cancer.

By executing these two strategies.

We were able to grow that you lost market share in both revenue and the number of new patients treated and.

And we plan to carry that momentum into the fourth quarter. When we expect to enter into anarchy at negotiations for first line ovarian cancer.

We're confident that overtime, so July will be the market leading.

PARP inhibitor in China for ovarian cancer.

Tao Fu: Similarly, the launch of Optum is going well. During the third quarter, our team focused on continuing to improve market access by expanding commercial insurance and supplemental insurance coverage for optum and educating target physicians about its significant clinical benefits, including survival benefits. Currently, Optum is covered by 25 municipal or provincial supplemental insurance plans.

Similarly, the launch of <unk> is going well.

During the third quarter, our team focused on continuing to improve market access by expanding commercial insurance and supplemental insurance coverage brought him.

Educating targets positions about its significant clinical benefits, including survival benefits.

Currently <unk> is covered by 'twenty, five municipal or provincial supplemental insurance claims.

The implementation of some of the newly added plans in the fourth quarter.

That's a good opportunity for us to grow option.

We have also kicked off several important physician education campaigns and.

And plan to establish a GBM patient journey management platform to increase the number of patients treated.

As we noted last quarter, we successfully launched the team law for fourth line Gist in China last may.

And we're still very early in our launch process.

The key focus of our launch.

Creasing physician awareness and the number of patients treated by leveraging the Invictus trial data.

<unk> status as the only later line gist treatment, regardless of the mutation status.

Well as the guideline recommendation by the Chinese society of clinical oncology.

In the third quarter. We also received approval for and launch can lock in Taiwan, making.

Making it the first ever product that is available to all parts of the greater China region. During the first year of launch.

Tao Fu: As Alan mentioned earlier, we're still assessing the impact of the intrigue results. We're committed to establishing Kinloch as the standard treatment for fourth line GIST based on its compelling product profile, extending patient survival, and we will make appropriate adjustments to our commercial strategy. Now Billy Cho will discuss our third quarter financial results. Billy.

As Alan mentioned earlier.

We're still assessing the impact of it.

Treat result.

We're committed to establish kinlaw Alco standard treatment for fourth line Gist based on its compelling product profile extending patient survival and.

We will make appropriate adjustments to our commercial strategy.

And now Billy Cho will discuss our third quarter financial results.

Unknown Attendee: Thank you, Tao. We saw continued significant growth and strong performance across our business. Today, I'll briefly summarize our financial results for the third quarter and year-to-date 2021. Revenues for the third quarter and year-to-date in 2021 were $43.1 million and $100.1 million, respectively. Over the same period last year, revenues were $14.7 million and $33.9 million. We're still early in our commercialization phase, but we're very pleased with the successful launches and sales trajectory of our first three oncology products.

Thank you Tal.

We saw continued significant growth a strong performance across our business today I'll briefly summarize our financial results for the third quarter as well as year to date 2021.

Revenues for the third quarter and year to date in 2021 grew $43 $1 million and $100 $1 million respectively.

Over the same period last year revenues were $14 $7 million and $33 $9 million respectively.

We're still early commercialization phase, but we're very pleased with the successful launches and sales trajectory of the first three oncology products.

Unknown Attendee: With many more product launches anticipated, our commercial platform is expected to generate strong growth and considerable operating leverage. Digital sales for the third quarter in New York State 2021 were $28.2 million and $64.2 million, respectively. And over the same period last year, digital sales were $8.5 million and $22.3 million or so. Opt-in sales for third quarter near-to-date 2021 were $10.7 million and $27.3 million, respectively. And over the same period last year, opt-in sales were $6 million and $11.4 million, respectively. Kinloch filled the third quarter in year-to-date stuff 21 for $4.3 million and $8.7 million.

With many more product launches anticipated our commercial platform over time is expected to generate strong growth and considerable operating leverage.

Digital sales for third quarter, and you take 2021 were $28 $2 million at $54 $2 million respectively.

Over the same period last year did you look sales were $8 5 million and $22 $3 million respectively.

Auto sales for third quarter and year to date publicly one with $10 7 million and $27 $3 million, respectively. Over the same period last year sales of $6 million and $11 $4 million, respectively killer sales for third quarter and year to date stopped 21 were $4 3 million and $8 7 million.

Research and development expenses were $55 $1 million for the three months ended September 30 of 2021 compared to $58 $1 million for the same period in 2020.

Selling general and administrative expenses were $59 million for the three months ended September 32021, compared to $27 $9 million for the same periods 2020.

The increase was primarily due to payroll and payroll related expenses from increased commercial headcount and expanded commercial activities as dial up continued to expand its commercial operations throughout greater China.

For the three months ended September 32021, Diab reported a net loss of $96 $4 million or a loss per share attributable to common stockholders of $1 one set.

We're to a net loss of $63 7 million or a loss per share attributable to common stockholders of 84 for the same period in 2020.

As of September 32021, cash and cash equivalents short term investments and restricted cash totaled $1.57 billion compared to $1 $9 billion as of December 31, 2020.

Unknown Attendee: Research and development expenses were $55.1 million for the three months ended September 30, 2021, compared to $58.1 million for the same period in 2020. The decrease in R&D expenses was primarily due to lower upfront payments for new licensing agreements, partially offset by the increase in expenses related to ongoing and newly initiated late-stage clinical trials and payroll and payroll-related expenses from increased R&D. Selling general and administrative expenses were $59 million for the three-month-ended September 30, 2021, compared to $27.9 million for the same period in 2020.

I would now like to turn the call back over to the operator to open up the line for questions.

Operator.

Certainly ladies and gentlemen, we will now begin the question and answer session. If you wish to ask a question. Please press star one on your telephone keypad and wait for you it needs to be announced if you wish to cancel your request.

You can press the pound or hashed E.

Excuse me kindly ask two questions both opposition to allow everyone a chance.

We have the first question, which is coming from the line of Mike <unk> from Jefferies. Please go ahead.

Hi, Thank you very much and congrats on a great quarter. We had two questions. The first was obviously on the announcement of the Corona transaction.

This brings you into a pretty.

Big market opportunity and neurology, but also more complex one can you just comment on how you're thinking about.

Unknown Attendee: The increase was primarily due to payroll and payroll-related expenses from increased commercial headcount and expanded commercial activities, as Zai Lab continued to expand its commercial operations throughout Greater China. For the three months ended September 30, 2021, Zai Lab reported a net loss of $96.4 million, or a loss per share attributable to common stockholders of $1.01. Compared to a net loss of $63.7 million, or a loss per share attributable to common stockholders of $0.84, for the same period on the stock market. As of September 30, 2021, cash and cash equivalents, short-term investments, and restricted cash totaled $1.57 billion compared to $1.19 billion as of December 31, 2021.

Energy and being opportunistic in neurology now going forward.

What that means for business development for U.

And the second question is you.

You had made some nice comments about it.

<unk>.

The <unk> compound can you just remind us about your confidence level in regulatory discussions and the potential faster filing in 2022, and if you could do that that would be that would be huge. So it would just love to know if you actually think thats possible. Thank you.

Thanks, Mike.

Quite a bit.

This is Billy.

Several members of our.

Matthew came on sorry about the background noise. We have several other members of our management team helped drive traffic for your first question and our entry into neuroscience.

So I wanted to take this and I'm sure other party can chime in as needed.

Okay.

Sure. Thanks for the question.

I think first of all it is actually a similarity.

In Adjacencies for this expansion into neuroscience.

And I like what we have done in the past.

Going into sort of severe autoimmune diseases with that God go into.

Hematology.

Operator: We would now like to turn the call back over to the operator to open up the line for questions. Operator. Certainly. Ladies and gentlemen, we will now begin the question and answer session. If you wish to ask a question, please press star 1 on your telephone keypad and wait for your name to be announced. If you wish to cancel your request, you can press the pound or hash key.

With our regeneron collaboration.

There's been a lot of obviously thought ascribe a diving.

As we go into new areas. So when we go to new areas, there's always similarity.

Okay.

<unk> first of all is that.

Especially with this drug.

Where patients go see carrier, China, it's very concentrated.

There's a very limited number of.

In fact, gastric hospitals, where patients go get care, there's about a thousand of them.

Michael Jonathan Yee: We would request you to kindly ask two questions of the participants to allow everyone to continue. We have the first question, which is coming from the line of Michael Yee from Jefferies. Please go ahead. Hi. Thank you very much and congratulations on a great quarter. We had two questions. The first was obviously on the announcement of the Karuna transaction.

In addition, the large class three hospitals.

Only a very limited number of them have these psychiatric department within them.

So therefore.

The amount of sales team that is required to.

Commercialize there's very limited I mean, if you look at.

Some of the currently leading companies in China focus in this area that Salesforce is somewhere between 100 to 300 FTE.

And I think that brings to my second point is that Theres adjacency to our current business because.

Michael Jonathan Yee: This brings you into a pretty big market opportunity in neurology, but also a complex one. Can you just comment on how you're thinking about synergy and being opportunistic in neurology now going forward and what that means for business development for you? And the second question is, you made some nice comments about Efkart Dijamad, the Argenix compound. Can you just remind us about your confidence level in regulatory discussions and the potential faster filing in 2022? If you could do that, that would be huge. So I'd just love to know if you actually think that's possible. Thank you.

If you look at the first.

Indication.

Within urology.

PMT.

So before we launch correct hopefully we already have a commercial team on the ground.

All in <unk>.

And building up the network in this area.

So you know it's been a very thought process as we go into New York Times, It's a very big market.

Right behind oncology immunology, one of the largest CIA in China or in fact, a very high growing double digit even though theres very lack of innovative products.

So you know this product being very differentiated.

The offering both on the efficacy side is Burke Becky side create differentiation compared to the standard per se.

We are very confident about the commercial viability given our presence already in urology.

Unknown Speaker: Several members of our management team are on; sorry about the background noise.

Given the vacancy of different kind of product and in terms of the future BD effort.

Unknown Speaker: Unsponsored ADR So thanks for the question, Mike. I think, you know, first of all, there's actually a similarity and adjacencies for this Expansion to Neuroscience. Like what we have done in the past, going into sort of severe autoimmune diseases with EFGAR, going to, you know, hematology, you know, with our Regeneron collaboration, there's been a lot of, obviously, thought and strategizing as we go into new areas. So when we go into new areas, there's always similarities. In this case...

Look when we get into a new area, we were bringing in anchor product lifestyle product.

So this is a product here, we obviously are going to continue to look for assets.

That may be synergistic with this.

And expand our CNS pipeline.

With similar.

They got that.

But certainly it will be on the lockup with us.

And Mike for your second question that's right.

Yeah, Mike for your second question on that part to demand you're right. We did make a mouse pads.

On our third quarter earnings that we have the potential to cause.

The approval of diversification My first house I guess here in your question was are pumped this level of that.

Unknown Speaker: The similarity, first of all, is that, you know, especially with this drug, where patients go to seek care in China, it's very concentrated. So there's a very limited number of psychiatric hospitals where patients go get care. There are about a thousand of them.

Somebody said would you like to provide some commentary on this.

Sure.

Thank you Michael for the question.

That's where they are we are very optimistic about the potential salary cost.

And for me.

Also in the first half of <unk>.

Unknown Speaker: In addition, you know, the large Class 3A hospitals, you know, only a very limited number of them have these psychiatric departments within them. So therefore, you know, the amount of sales staff that's required to commercialize this is very limited. I mean, if you look at, some of the currently leading companies in China are focused on this area; their sales force is somewhere between 100 to 300 FTEs. And I think that brings to my second point, which is that there's adjacency to our current business because, you know, if you look at FCAR, the first indication is within neurology.

<unk> can be two based on our discussion with the city.

Sure.

Okay sounds good.

Thank you.

Yeah. Thanks, Mike.

Do you have the next question is coming from the line of Gail Michel more of it.

From Citigroup. Please go ahead.

Hi team. Thank you very much for taking my questions I have three.

First I was just wondering about the jaws current market share in second line ovarian in China, and how that market share has been trending since the June we'll watch.

Second I'm curious about the distribution of sales person across the 1100 tier one two and three hospitals, whereas the Juliet is available.

Is there a certain tier where youre seeing most sales are the sales evenly distributed across cross hospital tears and finally.

Unknown Speaker: It's in D&D. So, you know, before we launch CAR-XC, hopefully, we will already have a commercial team on the ground, selling FCAR and building up the care networks in this area. So, you know, it's been a very slow process as we go into neuroscience.

Just curious what are the gating factors for when you will begin to introduce revenue guidance for the jeweler and also for up to.

Yeah.

Alright, you all and thank you for your question.

So I'll.

I'll kick it off on all three and by other colleagues who joined it needed so that you're the second line market share.

Unknown Speaker: It's a very big market. You know, it's right behind oncology and immunology, one of the largest TAs in China. In fact, a very high growing TA, you know, double digit growth, even though there is a lack of innovative products. So, you know, this part of being very differentiated, you know, offering both on the efficacy side as well as the safety side, clear differentiation compared to the standard of care today, we are very confident about the commercial viability, given our presence already in New Orleans. Unsponsored ADR

We.

We are not providing specific guidance at this point you can.

Information like you do in the U S.

Throughout Q V et cetera to get to get views on it what I can share with you. You go is that with the introduction of jewelry in the marketplace.

In second line, which is a <unk> product and then of course with first line as the only all comer labeled PARP inhibitor in a very cancer clearly we've seen not only the increasing of the pie of the part penetration, but also our market share within it and that's both within second line and also.

Unknown Speaker: And Mike, for your second question on F-14... Yeah, Mike, for your second question on F. Cartesian Mod, you're right; we did make an announcement about our third quarter earnings.

And increasingly so in the first line. So we're very optimistic that this trend will continue.

Unknown Speaker: Unsponsored ADR Sure. Thank you

And and and so hopefully that helps you.

And we will provide additional color as we make further progress and we're very confident that we're really set up here to have a commanding market share position for us that you would like to bring to the space.

But not too distant future.

Your second question on the distribution of sales between tier one two or three sort of in a.

Unknown Speaker: Okay, sounds good. Thank you. Yeah, thank you.

Yigal Dov Nochomovitz: Do you have the next question? This is coming from the line of Yigal Nochomovitz from Citigroup. Please go ahead. Hi, Billy and team. Thank you very much for taking the questions. I had three.

Hospitals or geographies clearly our initial focus was to really make sure that we penetrate the class three hospitals in the top tier one two cities.

Yigal Dov Nochomovitz: First, I was just wondering about Zajula's current market share in second-line ovarian cancer in China and how that market share has been trending since the Zajula launch. Second, I'm curious about the distribution of sales for Zajula across the 1,100, Pier 1, 2, and 3 hospitals where Zajula is available. Is there a certain tier where you're seeing most sales, or are the sales evenly distributed across hospital tiers? And finally, just curious, what are the gating factors for when you will begin to introduce revenue guidance for Zajula and also for Optum?

So we're optimistic that we're well positioned.

For NRT Oh Oh.

<unk> on first line as well and that's when you're also going to see not only a chaotic impact of the volume going up but also a broader distribution as well and then in terms of any.

Gating factors for revenue guidance.

So I guess the worst.

Still very much early in our lifecycle in terms of commercialization as we noted on the on the call.

Unknown Speaker: Alright, Yigal. Thank you for your question.

Unknown Speaker: I'll kick it off on all three and invite other colleagues to join if needed. So, for Joola's second-line market share, we are not providing specific guidance at this point. You can access information like you do in the U.S. through IQVIA, etc., to get views on it.

Every month that goes by clearly, we're getting more momentum even more.

Hard real data.

Insights all of that and our commercial platform continues to.

To execute with strong growth and productivity. So there will be appointed time, but that point in time, it's not at this moment.

Unknown Speaker: What I can share with you, Yigal, is that, you know, with the introduction of Joola in the marketplace, you know, in second-line, which is a NRDL reimbursed product, and then, of course, with first-line as the only all-comer labeled PARP inhibitor in ovarian cancer, clearly, we've seen not only the pie of PARP penetration increase, but also our market share within it. And that's both within the second line and also increasingly so in our first line.

Gotcha. Thank you very much.

Thanks Yigal.

The next question comes from the line of anecdote Rama from GPM Q School head.

Hey, guys. Thanks, so much for taking the question.

I've got two quick ones, maybe following up on my <unk> question on neurology.

Talking about business development, but will there also be an interim build out of an internal kind of research effort on the neuro side and then second question.

Unknown Speaker: So we're very optimistic that this trend will continue, and so hopefully that helps you, and we could provide additional color as we make further progress. And we're very confident that we're really set up here to have a commanding market share position for Zejula in the very near future.

I think there was a mention of NR Dl for first line did you I wanted to confirm that Quint locked is also going to be.

And our Dl.

Submission and when those pricing effects could take place in 2022, thanks, so much.

Hey, I'm a pump I'll address the second question and then.

Unknown Speaker: Your second question on the distribution of sales as a doula between tier one, two, and three hospitals or geographies. Clearly, our initial focus was to really make sure that we penetrated the class three hospitals in the top tier one, two cities, and we have the benefit of that legacy with strong execution. Now with the second line in NRDL, we have nationwide coverage. The first line is still private pay, and so we're optimistic that we're well positioned for NRDL negotiation on the first line as well, and that's when you're also gonna see not only a dramatic impact of the volume going up, but also a broader distribution as well. And then, in terms of any gating factors for revenue guidance, I guess we're still very early.

Teed up for the team on your first question.

So yes, you heard right.

The first line so for energen negotiation, particularly in first line.

It will be happening, we're well prepared and we're optimistic.

But we're well prepared for a good outcome, but that's to be determined what you will hear in the public domain will be very similar to last year and previous years, where the drug had made at the pumps and drugs who've made it on the <unk> and accepted will be made public by the Anr deal a few weeks after.

The negotiation finalized, which you know is happening in very near term and then the most of the companies will be filing an NDA. So you will not hear about the price.

Until until the implementation date, which will be likely January of next year early next year. This year not like March.

Unknown Speaker: Unsponsored ADR

Anupam Rama: Thank you very much. The next question comes from the line of Anupam Rama from Japan. Please go ahead. Hey guys.

It's likely to start in 'twenty, one where implementation date was March next year is expected to be happening to usual Chinese cycle. So that's the cadence and so there'll be more to come but again, we're optimistic that keytruda will be a very important drug for many more patients.

Anupam Rama: Thanks so much for taking the question. I've got two quick ones. Maybe following up on Mike Yee's question on neurology, you talked about business development, but will there also be an internal build out of some kind of internal research effort on the neuro side? And then there was another question. I think there was a mention of NRDL for Firstline, so I wanted to confirm that Kinloch is also going to be NRDL compliant and when those pricing effects could take place in 2022. Thanks so much.

And I think we'll have a dominating our commanding market share positioning the PARP class for ovarian cancer patients now for kinlaw, we were eligible.

Launch the advance just a label in October 20th each year.

Which means we were eligible to be included in the NRT L negotiation, we've elected not to.

Because we have an ability to drive adoption.

And as the only really established itself as a standard of care as Alan mentioned.

In advanced yet and so we have another opportunity next year to do so and so we have good optionality there.

Unknown Speaker: Hey Anupam, I'll address your second question and then key it up for the team on your first question. Uh, so yeah, you heard the right first line. Uh, for energy negotiation, particularly in the first line.

Your first question on neurology, where we're going to build out our internal.

Search capability, there as you know and Palm Beach.

We've.

You can really dedicated energy towards oncology.

Unknown Speaker: Unsponsored ADR Unsponsored ADR Unsponsored ADR Unsponsored ADR

Our immunity, but in terms of neurology I mean, we just signed this deal.

Unknown Speaker: Your first question on neurology is where we're going to build out, you know, our internal, you know, research capabilities there. As you know, Anupam, we

It is hard to depress you know yesterday, but in terms of building that out I don't know what the other comment though you know Alan Harold if you have additional comments on that or Samantha Harold.

Unknown Speaker: Unsponsored ADR

Unknown Speaker: Yeah, I can just... Thanks.

Yeah two.

Unknown Speaker: Go ahead. Go ahead, Harald. Go ahead.

Thanks go ahead Oh.

Unknown Speaker: Hi, thank you for the question. Will there be a build-out in neurosciences? The answer is yes. This is a big new addition to our current franchise. It does require extra work, it will require extra dedication, and it has huge potential. This is a big new market for us.

Oh go ahead.

Yeah, Hi, Thank you for the question will there be a built out in Neurosciences and the.

Ccs.

This is a big New addition to our current franchise.

Thats required extra where it gets really require an extent education and.

It has huge potential this is a big new market for us, but it's not an unknown market because we have had already experiencing the neuroscience world.

Unknown Speaker: But it's not an unknown market, because as mentioned before, we have experience in the neuroscience world, and as mentioned before, we have on the FKTGMOD side at least two programs that are in neurology, and that is GMG, obviously, and CIDP. So, yes, there will be a build-out in the clinical and also in the sales team. It will be for commercialization in those hospitals in China that have psychiatric units, which actually is not too much, but it will not require a large team. So we think it's worthwhile. And, One point, maybe in addition to your question, why do we go into this area?

As mentioned before we have on the <unk> side at least two programs that are in neurology and that is TMT, obviously in <unk> P C.

So yes, there will be built out in clinical and also in the sales team it will be for commercialization in those hospitals in China that has thank.

Thank you Patrick units.

Actually it's not too much but it did not recur.

Airlines team. So we think it's worthwhile and.

One point maybe in addition to your question why do we go into this area because we understand the mechanism.

Unknown Speaker: Because we understand the mechanism. This is a well thought out mechanism of an antagonist and an agonist working on the M1 and M4 muscarinic receptors. And that's a very well established approach.

This is a well thought out mechanism opened antagonist in an agonist working on.

One four which can really receptor.

And that's a very well established.

It's one that hasn't been really tried it because of it.

But the answer is cooked in the areas within the antagonist, Luke and dopamine and serotonin.

So there's also a lot of data in support of this so with all of this gives us confidence together with the you mentioned one trial data.

This is something we can really sprint flu footprint.

Yes.

Thank you.

Yeah, I think thank so in Nepal, and cloud I think hurt the product put it as it comes about.

Unknown Speaker: I think Harold brought up a very good point about branching out into this area with a lot of information. But in terms of discovery, Anupam, we're not interested in building our own vision. We're still focusing on oncology and opioid use.

Brent.

Into this area.

Is that a lot of information.

In terms of discovery and a pump will not be updating our own interests.

Mhm focus on oncology.

Unknown Speaker: Thank you. We have the next question. This is coming from the line of Jonathan Chang. Please go ahead.

Thanks for taking my question.

They've got it Bob.

Thank you we have the next question is coming from the line of Jonathan Chang from school.

Hi, guys. Thanks for taking the questions.

First question can you discuss your check cancerous strategy following the recent.

<unk> study results I can provide any color around how you're thinking about potential next steps.

Yes.

Oh, well pass that to our outlook.

Unknown Attendee: Great. Thanks. Thanks very much for the question. I think for next steps at this particular point, we believe very strongly in our world-class GI cancer portfolio and specifically for Kinloch in the fourth-line setting, which, again, as has been noted in a randomized study, showed a significant overall survival benefit. So we'll continue to look and work in that particular area, and we'll continue to build upon that. In addition, of course, we're looking forward to working with Decipher to evaluate the data from the original study and see what sort of opportunities we have moving forward, which potentially could include combinatorial approaches as well. So that's the approach we'll be taking at this point. Thank you so much for the question. I got it.

Okay.

Great. Thanks, Thanks, very much for the question I think for next.

Next steps at this at this particular point.

We believe very strongly in our world class Gi cancer portfolio and specifically.

Sure.

In the fourth line setting, which again has been noted in a randomized study showed a significant overall survival benefit. So we will continue to look.

And in that particular area continuing to build upon that in addition of course, we're looking forward to working with the <unk>.

To evaluate the data from the original study and see what sort of opportunities we have moving forward, which potentially could include combinatorial approaches as well. So that's the that's the approach we'll be taking at this point. Thank you so much for the question.

Got it. Thank you and second question can you provide any color around how the opportune lunar study is progressing are you able to provide any more granular color when the study could read out.

Unknown Speaker: And second question, can you provide any color around how the Poptun Lunar Study is progressing? Are you able to provide any more granular details when the study can read up? Thank you. Alan, would you like to comment on this one as well? Yes.

Yeah.

Alan would you like to comment on this one as well.

Yes I'm good. Thanks for the question. This is something that of course is.

Unknown Attendee: Again, thanks for the question. This is something that, of course, is a study that's been accruing and is run, of course, by our partner, Novacure, and we're still working with them on this and participating in that study and waiting again for the accrual to finish. And as you know, given the recommendations by the DMFC, the follow-up for the study has been reduced from 18 months to 12 months in terms of the minimal follow-up, so that might provide you with a little bit of guidance as to when we'll start to see data, potentially after completion of accrual.

That's been accruing in this round of course by our.

Our partner Novocure, and we're still and we're working with them on this and participating in that study and waiting.

Again for the accrual to finish and as you know given.

The recommendations by the a T M a C.

The follow up for the study has been reduced from 18 months to 12 months. So.

In terms of the minimal follow up so that might provide you with a little bit of guidance as to when we'll start to see that potentially after completion of accrual.

Unknown Speaker: Yeah, Jonathan, you know, nobody else would be saying that now, and I'm not. I don't think that they've only got one.

Thank you again.

Yes.

Local curiosity sake.

The pony.

The 2022 milestone.

The final data speed that out.

So I hope you decided to whether it could be first half second half.

You know it's going to be.

Anticipated milestone for next year.

Got it thanks for taking the questions.

It takes all of them.

Yes.

We have the next question is coming from the line of Seamus Fernandez from Guggenheim Securities. Please go ahead.

Oh, thanks, guys.

Seamus Christopher Fernandez: Just a couple of quick questions. First, AstraZeneca in its filing documents has noted a patent expiration for LIMPARSA in 2024. Just wanted to get a little bit more color on how you guys are assessing the patent landscape in China. You know, are you anticipating the entry of generic LIMPARSA in 2024 or shortly thereafter? And if not, why not?

Just a couple of quick questions first astrazeneca in it.

Filing documents.

Has noted a patent exploration for one part of that in 2024.

I just wanted to get a little bit more color on how you guys are assessing the patent landscape.

In China.

Should are you anticipating the entry of generics in 2024 shortly thereafter.

And if not.

Seamus Christopher Fernandez: Have you assessed the patent landscape and feel that LIMPARSA is likely to be protected longer? If there are generics that are introduced in 2024, what's your expectation for the evolution of the market from that point in time? And my second question really relates to, you know, the expansion and earlier stage opportunity for Optune. What are you guys doing at this point to prepare for a potential expansion should the phase two or the trial, the lunar trial, read out positively, to basically prepare for uptake and demand?

Why not is there.

Have you assessed the patent landscape and feel that.

Cars is likely to be protected longer.

If there are generic that are introduced in 2024.

What's your expectation for the evolution of the market.

From that point in time.

And my second question.

It really relates to that.

The.

Shan and earlier stage opportunity.

Opportune what are you guys doing at this point to prepare for a potential expansion should be that the phase two.

Trial.

Our lunar trial readout positively to.

Unknown Speaker: Hey Seamus, thank you for your questions. I think the first one is, John. Would you like to take it? And then I'll take the second one.

So basically.

Prepare for uptake in demand.

Okay. Thank you for your questions.

I think the first one John would you like to take it and then I'll take the second one.

Jonathan J. Wang: Thanks for the question, Seamus. Let me first say that we have a very strong pattern. Unsponsored ADR, And we have a very differentiated product. So even if there is a generic that comes to the market after Linpao's patent expiration, we have very differentiated assets. In particular, we're the only asset that has the all-comer monotherapy label in first line. And we're rapidly gaining market share, you know, as we're on the second line, NRDL, as we have, you know, a better product.

Sure. Thanks for the question Seamus.

Let me first say that we have a very strong patent position.

Great.

We have a strong composition of matter patent that lost almost to the end of this decade.

And we have a very different set of product. So even if there is generic that comes to the market. After the impact of the patent expire operation we have very differentiated assets in particular, where the only asset that has the all comer monotherapy label impress ly.

And we rapidly gaining market share as we're being the second line and as we have.

Better product now as we have an idea on negotiations that's currently ongoing.

Successful to get onto the frontline for <unk>, we will have an even stronger market position, we will solidify.

Our broader label.

Therefore, I think with a different set of product with a strong patent position, we can dominate the market for a very long time with that.

And again as for your second question on tumor treating fields.

So off to and obviously, we have it in the markets as you know second half of last year. Our dedicated commercial team are doing a great job covering the top hospitals in opportune for GBM.

The top 250 hospitals and in fact, they covered to neurology two radiotherapy department, we have a dedicated DSS team.

And who continue to provide patient care and education.

And and.

There's also been a great job with the supplemental insurance you saw from our earnings release that we have up to about 25 or something with the insurance plan signed up. So this is going to bode well.

Unknown Speaker: And Seamus, for your second question on tumor treating fields, so Optune, obviously, we have it in the market since, you know, the second half of last year. Our dedicated, you know, commercial team has been doing a great job covering the top hospitals. In Optune for GBM, there are about 250 hospitals and great coverage from neurology to radiotherapy departments. We have a dedicated DSS team.

For not only up to really positioning and building awareness for tumor treating fields in the future across indications now next year obviously.

Mutual immuno readout is going to be an important milestone, but ahead of that there's a lot of things we'll be doing. So in addition to other indications and global phase three trials.

And we just wrapped up a ton of all the phase II trial, and we will have data out for that bypass the first half of next year.

We're also been preparing to submit a second indication in mesothelioma and as you know it just gives us a strategic opportunity to engage with the lung cancer community ahead of a possible positive outcome for the lunar trial. So we can really optimize.

That did that event if it was positive so we remain optimistic on all of those fronts and continue to be big believers.

You know the potential tumor treating fields to serve many many more patients than what.

Unknown Speaker: Unsponsored ADR Unsponsored ADR Unsponsored ADR

Unknown Speaker: I think we can move on to the next question, operator.

What we're doing right now.

Yeah.

So thanks very much for your questions.

I think we can move on to the.

Next question operator.

The next question comes from <unk> Chen from Goldman Sachs. Please go ahead.

Ziyi Chen: Certainly. The next question comes from Ziyi Chen from Goldman Sachs. Please go ahead.

Thanks for taking my questions.

Couple of questions on the recent deals number one is on Bluebird, two egfr assets I'm trying to understand a bit more about the two molecules preclinical tox how's the therapeutic window look like and also for their clinical strategy in China.

Ziyi Chen: Number one is on the Bluebird 2 eGFR assets. I'm trying to understand a bit more about the two molecules' preclinical talks, you know, what the therapeutic window looks like, and also for their clinical strategy in China, because, you know, the third generation eGFR, including TechRacial, and some of the domestic brands are going to potentially become the standard of care in China in the first line, second line setting. And some of them also show decent brain blood barrier penetration.

Third generation Egfr in clothing Tech, Rachel and if some of the domestic.

And she's going to potentially becoming the standard of care in China in a circus first line second line setting and some of them also show a decent.

The framework barriers penetration so well.

Unknown Speaker: So, will the BLU 945 and the 701, mainly targeting the patient failed, the third generation EGFR, or if we're trying to move it into earlier lives, I guess we have to have study will be inevitable. Any chance that the combo could potentially beat the third generation EGFR in terms of survival benefits to patients? You know, try to understand a bit more about your thoughts here. And also for Unsponsored ADR. So, what could potentially be the pricing strategy here in China and how we should look at the commercial potential.

B L U $9 45, and a 701, mainly targeting the patient failed the third generation Egfr or if we tried to move it into earlier lines.

I guess, how to have study will be inevitable any chance out of the combo could potentially beat that search interchange fri, it and the survival benefits to patients you know.

Trying to understand a bit more about your thoughts here and also for.

For car X P.

While we understand there is a large population of schizophrenia.

Our ski a little friendly a patient in China.

Six minute plus however, a lot of them actually I mean, the poor financial condition, so if volatility might be a big challenge.

Unknown Attendee: Thank you. Thank you for your questions. Allen, would you like to take questions on the EGFR? Sure. Thanks. Thanks, John. Thanks, Lillian.

Particularly given available standard of care now are super cheap, so what could potentially be the pricing strategy here in China, and how we should look at the commercial potential. Thank you.

Thank you for your questions, although would you like to take this questions around the Egfr.

Unknown Attendee: Thanks for the question. So, there are a couple aspects. I think I can probably lump those together.

Sure. Thanks, Thanks, John Thanks for the question. So couple aspects I think I can probably lump those together. The initial one was more of a sort of a toxicity.

Unknown Attendee: The initial one was more sort of the toxicity. And, you know, for these two agents, there's wonderful preclinical data that shows exceptional wild-type sparing effects. And so, that is the main cause for toxicity with these types of agents. Therefore, by limiting the effects on the wild type, there should be fewer toxicities such as dermatological and diarrhea. So, that's one potential advantage. And it also, what it does is it allows for the potential for combination of these two agents.

For these two agents, there's wonderful preclinical data that shows exceptional wild type sparing effects and so that's.

That is the main cause for toxicity with these types of agents are limited by limiting the effect on the wild type there should be fewer toxicities, such as Dermatologic and diarrhea. So that's one potential advantage and it also what it does is it allows for the potential for combination of these two agents and that's.

Unknown Attendee: And that's a very key element for this because by combining these two agents based on preclinical data, you not only have limited wild type, but you also impact those original mutations in EGFR and then also resistance, such as, again, T790 and C797S. So, that allows for coverage that is actually, in some ways, similar to that of Targaryso and then superior because it can also potentially overcome the escape mechanism, and the resistance mechanisms.

A very key element for this because by combining these two agents based on preclinical data you not only have a limited wild type you'll also impact those original.

And mutations.

In Egfr and then also the resistance such as again the T. 790, 797 asked so that allows for coverage that is actually in some ways similar to that at time to agree so and then superior because it also can potentially overcome the escape mechanism does.

Unknown Attendee: So, although the initial study of these agents will be in resistance because that's a faster path to approval, ultimately, moving and looking at this combination in the frontline setting is certainly a logical approach. And we're confident, along with our partners at Blueprint, that there is an opportunity to be superior to Targaryso in this area. Thank you so much for the question. And Ziyi, for your second question. I'm sorry, there was one last question. They also have excellent blood brain barrier penetration as well, so resistance that occurs in the CNF will be overcome by these agents as well.

Distance mechanism. So although the initial study of these agents will be in resistance, because that's a faster path to approval.

To be superior to progress that we're in this area.

And thank you so much for the question.

Yeah.

And the second one.

I'm sorry, there was one last question.

We also have.

Excellent blood brain barrier penetration as well so resistance that occurs in the CNS.

Will be overcome by these agents as well.

Unknown Attendee: Thanks, Alan. And Ziyi, for your second question...

Sorry.

Thanks Ali.

Do you have for your second question the car T. Clearly we've done a lot of work around this as we always do for all of our programs, but I'll invite John to provide additional color.

Unknown Speaker: And Ziyi, for your second question on CAR-XT, clearly, we've done a lot of work around this, as we always do for all of our programs, but I'll invite John to provide additional details. Thanks for the question. First of all, the cheaper prices are due to it being pretty much mostly generic. However, all the products are on the NRDL, and in fact, when there's recently been a more recent launch product. Unsponsored ADR that addresses not only the positive symptoms of schizophrenia but, more importantly, addresses the negative symptoms, which currently, nothing out there does.

Yes, thanks for the question Larry.

Look I think first of all a cheaper prices due to its pretty much mostly generics.

However, order product and I'll deal with it and.

And in fact, when there is recently a more recent launch product.

In advance of an idea of the price cut was very limited for example in Vega and I only had a 5% to 10% price cut to get onto the N B L.

And its annual treatment cost is about four to 5000 U S dollars, but it's still very largely undifferentiated asset and that doesn't mean, you're not age.

Tea category.

So with this product that totally new MLA.

First and best in class attributes.

That addresses not only the positive symptoms of schizophrenia, but more importantly, addressing the negative symptoms, which colony nothing out there does.

Unknown Speaker: And with a much better tolerability profile, you know, for example, weight gain, QT elongation, you know, these kind of bad side effects, CARHT seems to do very well at, we believe it is definitely worth premium pricing. And then you couple that with, you know, there are about 8 million schizophrenia patients in China due to chronic usage. And because of better tolerability, you can have a much longer DOT, potentially.

With a much better tolerability profile for.

Example, weight gains Qt elongation kind of.

Bad side effects correct T seem to do very well as we believe it is definitely worth premium pricing and then you couple that with you know there's about 8 million schizophrenia patients in China. These are chronic usage.

And because of the better Tolerability you can have a much longer.

Jonathan J. Wang: And then beyond schizophrenia, obviously, it has potential for dementia-related psychosis. I mean, when there's nothing currently approved on the market, that is a very large market potential. So I think we should consider it as well. Thank you. Just a quick follow-up here. What is the patent status in China for correction? Yeah, look, it's undergoing prosecution.

Right.

And then beyond schizophrenia, obviously its potential in dementia related psychosis.

I mean when does nothing currently is approved on the market.

It is a very large market potential or something we should consider as well.

So hopefully this answers your question.

Thank you just a quick follow up here a well what is the patent status in China for a car T.

Yeah look it's undergoing the prosecution.

Unknown Speaker: You know, globally, its pattern has a pretty broad family pattern. There are two primary major families. The patterns are strong. You know, as you know, it includes two APIs. One of the APIs is not approved anywhere in the world. So there's no potential for any off-label usage.

Globally. Its pattern is a pretty broad family of patents two probably major family.

The patents are strong.

No. It includes two API is one of the eight does not approved anywhere in the world. So there's no potential any off label usage.

Yang Huang: But overall, in the US, you know, we're looking at the pattern up to 2039. And we believe we have a good opportunity here in China as well. Thank you. Thank you. Thank you. We have the next question. This is coming from Yang Huang from Kirk's Music School.

But overall in the U S. We're looking at the pattern up to 2039.

And we believe we have a good opportunity to get in China as well.

Thank you.

Okay.

Thank you do you have the next question is coming from young Wang from Credit Suisse. Please go ahead.

Yang Huang: Thanks. So I have two questions. First one is on Jula. So can you quickly comment on kind of what's a rough split for the Jula prescription in terms of, you know, ovarian cancer, first of all, maintaining therapy, and the second line, maintaining therapy in China right now. Just give us, you know, just give us some rough ideas would be great.

Thanks.

So I'll have to quest chance first of all why is all this July so.

Can you quickly comment on kind of what's a rough split.

For that show a lot of prescription in turmoil.

Around cancer first line maintenance therapy, and the second line maintenance therapy in China, right now just to give us.

Just give us a rough idea of what would be great and are there things.

Yang Huang: And then since our Jula is in the NIDL negotiation, I think it has, you know, a larger chance of being included for first line. And if first line is included in the NIDL, then in the kind of longer term, what's kind of a rough split between first line and second line prescription for Jula in the longer term? So that's my first question.

Our July zing deal.

Moshe I think it has.

Large upturn chassis can be included a full first lot and they have for first line, including the ideal.

On a longer term, what's kind of a rough split between first and second line.

First question on Closeouts Youre no longer in term.

That's my first question and my second question is about our Condor PD one strategy since we see.

Unknown Speaker: And my second question is about our kind of PD-1 strategy. Since we see in our portfolio, we don't have a PD-1 approved yet, but quite a few of our drugs, actually, our partners are doing a combo study for a brand called KRAS, and much taxonomic, but they're all doing combo studies. And the combo study with PD-1 has seen greater efficacy and safety. So can you clarify your PD-1 or PD-L1 kind of development strategy in China? Thank you.

Our part.

Portfolio, we don't have a PD one approved yet, but quite a few of our trucks actually our partner joining.

Combo, starting for Suncor, K, Ras and that much tucks them out because they're all dream combo started out on the combo study with PD, one have seen great efficacy and <unk>.

Okay.

Can you clarify your PD, one or PD L. One come out and throw them in Australia and China.

Hey, Jan Thank you for your questions.

So for the jewelry related question.

Well first of all as you've heard on this call.

Where you know for first line that you have the.

Unknown Speaker: Hey Yang, thank you for your question. So, for the digital-related question,

We had been selected quite a negotiation for NR deal inclusion, which would be going into effect early next year.

Unknown Speaker: For the Zajula-related question, first of all, as you've heard on this call, for first-line Zajula, we have been selected in the negotiation for NRDL inclusion, which will go into effect early next year, so there's a season for that. And I'd also like to remind you that we are and will be the only all-comer first-line monotherapy product in the market, and it's a very differentiated product profile, so the inclusion into the NRDL will significantly solidify our market position, and again, we're optimistic about the negotiation and the potential for Zajula to be a market-share leader in ovarian cancer.

So that's the secret to that and also like to remind you. We will we are and will be the only all comer first line monotherapy product in the market and it's a very differentiated product profile. So the inclusion into the inner deal will significantly.

Solidify our market position and again, we are optimistic on the negotiation and the potential that you would have to be a market share leader in ovarian cancer. So with you know with that.

First line, we've always been saying that the first line.

The indications where really the battle is going to be one and so we continue to have very much caucus around that.

At this time, we're not still getting split between first line second line kind of market share.

And revenue split as well, but just want to remind you young.

We recently launched the first line and its the private pay product.

And it was up against a reimbursed product, although there was quite a different label.

So you know.

We'll try to provide additional color as we go into as we wrap up our first it's really 2021 was our first full calendar.

The year of commercialization. So we're still very much ramping up so I hope you understand in terms of your second question on PD one strategy.

Unknown Speaker: Unsponsored ADR

Unknown Speaker: Unsponsored ADR Unsponsored AD

Unknown Speaker: Unsponsored ADR

You're right in that Oh, we buy it.

Unknown Speaker: You know, you're right in that, and I'll invite Alan to also comment here, but we have several combos, and you know, in the future we'll have additional, what we call orthogonal synergies that we expect to realize, and that'll be quite proprietary, but you already listed a few that are ongoing, KRAP, and they just had an update, you know, I think a day or two ago, an incremental update on the combo for lungs, that was quite interesting, we have, you know, MARG, Zijula, right, there's PD-1, late-stage combo trials, you know, in two very large indications, you know, frontline lung and breast cancer as well.

L L and to also comment here, but we have several combos.

And in the future will have additional what we call or talking to synergies that we expect to realize and that'll be quite proprietary but you're already listed a few that are ongoing K rapidly. They just headed in and update you know take a day or two ago increment to update on the combo for long thought was quite interesting.

March and even into July right. This PD one late stage public trials.

In two very large indication.

Frontline lung and.

<unk> cancer as well.

And so.

Great and it'll be strategic for us to have a you know not only PD, one, but they have a unencumbered portfolio within immuno oncology to really.

Go out there and fully realize those orthogonal synergy opportunities, but Alan do you want to.

Unknown Speaker: Unsponsored ADR

Unknown Attendee: Actually, Billy, you did a great job, and I don't have too much more to add other than that we will continue with the studies that we're doing to establish our PD-1 retrofanilamab as an opportunity for use such that we can then go on to those combinatorial approaches, as you mentioned. And again, you know, the KRAS is certainly an exciting one. There'll be other opportunities, of course, as well, along with that in second-generation IO combinations as well.

Provided any additional color.

But actually I believe you did a great job and I don't have too much more to add other than well continue with the studies that we're doing to establish a.

PD, one ret panel of bad debts as an opportunity for us such that we can then go onto those combinatorial approaches as you mentioned and again you know that.

Hey, Ross, it's certainly an exciting one and there'll be other opportunities of course as well along with that in a second generation I O combinations as well so yeah.

Unknown Attendee: So, yeah, thanks. Thanks very much for the question. Okay, thanks. Thank you. Thank you. I'm not asking any further questions at this time. I will now turn the call back over to Zai Lab's CEO, Samantha Jee, for closing remarks.

Yeah. Thanks, Thanks, very much for the question.

Okay perfect.

Thank you all.

Thank you I'm showing no further questions at this time I will now turn the call back over to <unk> CEO, Samantha Du for closing remarks.

Thank you operator.

Well I'm just thank everyone for taking the time to joining us on the call today.

Appreciate your support and look forward to updating you again after the fourth quarter.

Operator, you may now disconnect the call.

Q3 2021 Zai Lab Ltd Earnings Call

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