Half Year 2025 HUTCHMED (China) Ltd Earnings Call

Pete.

Just a quick moment on the disclaimer.

The performance and results of operations of <unk> group contained within this presentation now historically in nature and past performance is no guarantee of future results and actual results may vary materially from those set forth in the forward looking statement.

So today, we are very glad to have our CEO Dr. Sue.

David Ng: Great. Just a quick moment on the disclaimer. The performance and results of operation of HUTCHMED Group contained within this presentation are historical in nature, and past performance is no guarantee of future results, and actual results may vary materially from those set forth in the forward-looking statement. Today we are very glad to have our CEO, Dr. Su, our CFO, Mr. Cheng, our CMO, Dr. Shi, and our Head of Commercial, George Yuan, to go over the results and provide the latest update on our performance and the projects under development. As usual, we will have a Q&A session at the very end, when you can press the Raise Hand button to ask questions and/or type in the chat box. Please make sure you have your name and your company name on the screen.

Our CFO Mr. Chen.

Our C. A M O doctors, she and our head of commercial Mr. Yan to go over the results and provide the latest update on our performance and the projects under development.

You show, we will have a Q&A session at the very end when you can press the rays, but tend to ask questions and or typing the chat box, but please make sure you have your name and your company name on the screen. So now let us a welcome our Chief Executive Officer, and Chief Scientific Officer Doctor of Weibo's shoe too.

To begin I'll present presentation Dr. Sue.

Thank you David.

Speaker #2: Hello, everyone. This is David Ng, Head of Investor Relations of HUTCHMED. Thank you for joining HUTCHMED 2025 interim result presentation. Our results and presentation slides have already been posted on our homepage as well as on the Hong Kong Stock Exchange website.

If we go to the next slide.

So.

Again.

Good evening and good morning.

David Ng: Now, let us welcome our Chief Executive Officer and Chief Scientific Officer, Dr. Weiguo Su, to begin our presentation. Dr. Su?

Everyone.

Welcome to the Huntsman Midyear result conference call.

The highlight for the.

First half 2025.

Weiguo Su: Thank you, David. If we go to the next slide. Again, good evening, good morning, everyone. Welcome to the HUTCHMED Mid-Year Result Conference Call. The highlights for H1 2025, global commercial success. FRUZAQLA continues to grow H1, up 25% comparing to 2024. ORPATHYS or savolitinib, potentially our second global commercial product. There are filings ongoing based on SAVANNAH in some countries, and also, obviously, the global registrational study, SAFFRON study, is recruiting. We anticipate completion of recruitment later this year. Of course, ELUNATE in China, new indications, endometrial cancer, approved early this year, and RCC already filed as well. We do have a lot going on. We expect in the next 12 months, our phase III first-line non-small cell lung cancer, osimertinib plus savolitinib study called SANOVO, should complete enrollment very soon. If anything, I think we already fully enrolled.

Speaker #2: Just a quick moment on the disclaimer. The performance and results of operations of HUTCHMED Group contained within this presentation are historically in nature and past performance is no guarantee of future results and actual results may vary materially from those set forth in the forward-looking statement.

Global commercial success for zircon continues to grow first half.

Up 25% comparing to 2024.

Oh passes or <unk> Patel.

Potentially a second global commercial.

Speaker #2: So today, we are very glad to have our CEO, Dr. Su, our CFO, Mr. Chen, our MO, Dr. Xi, and our Head of Commercial, Mr. Yuan, to go over the results and provide the latest update on our performance.

Product.

There are filings ongoing.

Based on Savannah in some countries.

And also obviously the global.

Registered patients with study <unk> study.

Is recruiting we anticipate completion of recruitment later this year.

Speaker #2: And the projects under development. As usual, we will have a Q&A session at the very end. When you can press the raise hand button to ask questions and/or type in the chat box.

And of course, illuminate in China, new indications endometrial cancer approval.

Speaker #2: But please make sure you have your name and your company name on the screen. So now, let us welcome our Chief Executive Officer and Chief Scientific Officer, Dr. Weiguo Su, to begin our presentation.

Early this year and and and.

Or C C already filed as well.

Yeah.

We do have a lot going on we expect in the next 12 months.

Speaker #2: Dr. Su?

Speaker #3: Thank you, David. If we go to the next slide. So again, good evening, good morning, everyone. Welcome to the HUTCHMED Mid-Year Result Conference call.

Our phase III first line non small cell lung cancer.

All similar to the plus subtle its nib study called <unk>.

The novo.

Sure.

Sure.

Completed enrollment very very soon if anything I think we already fully enrolled.

Speaker #3: The highlights for the first half of 2025 include global commercial success. For example, it continues to grow, with the first half up 25% compared to 2024. All passes, all salvaging it.

Separately as I am.

<unk> should also complete recruitment sure Ali.

So with that in the phase two three study in first line pancreatic cancer phase two readout.

Speaker #3: Potentially, our second global commercial product there are filings ongoing. Based Savannah, in some countries, and also obviously the global registration of studies set from study is recruiting.

And in a phase III transitioning.

Uh huh.

<unk> progressing.

Weiguo Su: SAFFRON, as I mentioned, should also complete recruitment shortly. surufatinib phase II/III study in first-line pancreatic cancer phase II readout and phase III transition is progressing. Our FGFR inhibitor NDA submission is in preparation. Plan to file later this year. The savolitinib SAMETA study for pRCC globally and gastric cancer in China, NDA submissions are also planned. fruquintinib RCC, as I mentioned, NDA filed early this year, and within the next 12 months, we expect approval. The SAFFRON study, of course, the phase III readout should be sometime H1 next year. Our next generation innovation, very exciting ATTC programs. The first candidate, IND filing, coming up very soon, in a month or so, and we have more to come later this year. We are also exploring BD activities for not only our ATTC programs but other programs as well.

O F. Jeff for inhibitor NDA submission is in preparation.

Our plan to file late late later this year.

And the Saba led to Nib Sumita's study.

Speaker #3: We anticipate completion of recruitment later this year. And of course, alienate in China, new indications endometrial cancer approved early this year and RCC already filed as well.

For PRC see.

Globally, and gastric cancer in China NDA submissions.

Also.

Planned for quantum OCC as I mentioned.

NDA filed early this year and.

Within the next 12 months, we expect the approval.

Speaker #3: We do have a lot going on. We expect in the next 12 months our phase three first line non-small cell lung cancer are simultaneous with plus salvaging it.

The severance study of course is phase III readout.

Some of it should be sometime first half next year.

Our next generation innovation.

Speaker #3: The study calls Sanovo should complete enrollment very, very soon. If anything, I think we already fully enrolled set from, as I mentioned, should also complete recruitment shortly.

Very exciting ATT C programs.

First candidate Int filing.

Coming up very soon.

In a month or so and we have more to come later this year.

We're also exploring BD activities for now.

Speaker #3: Surfactant phase two, three study in first line pancreatic cancer phase two readout and phase three transition. Is progressing. Our FGFR inhibitor NDA submission is in preparation.

Not only our TC program, but other programs as well.

Yeah.

Without further Ado I'll, just turn it over to the next bigger.

Our CFO Jonny Chan to give you a financial.

Overview.

An update Johnny Thank you Dr. Shaw on page six we can see our balance sheet reflects a very strong cash position.

Speaker #3: Plan to file late this later this year. And the salvaging it Samita study for PRCC globally and gastric cancer in China. NDA submissions are also planned.

Over one 3 billion in cash resources, which includes proceeds from the partial divestment of our joint venture with Shanghai Pharma. So this resources will allow us to accelerate global ADC development and explore potential investment opportunities.

Weiguo Su: Without further ado, I will just hand it over to the next speaker, our CFO, Johnny Cheng, to give you a financial overview and update. Johnny?

Johnny Cheng: Thank you, Dr. Xu. On page 6, we can see our balance sheet reflects a very strong cash position. Over $1.3 billion in cash resources, which includes proceeds from the partial divestment of our joint venture with Shanghai Pharmaceuticals. These resources will allow us to accelerate global ATTC development and explore potential investment opportunities. Further down the balance sheet, under other non-current liabilities, we have deferred approximately $80 million of divestment gains as a provision for profit guarantee to the buyers. This will be recognized over the guarantee period, subject to the joint venture's performance in the next few years. Turning over to page 7, our P&L. Overall, the revenue for H1 2025 was $278 million, down 10% versus same time last year. Investments in R&D amounted to $72 million, reflecting multiple NDAs under review in China.

Speaker #3: Frequently RCC, as I mentioned, NDA filed early this year and within the next 12 months, we expect approval. The set from study, of course, is phase three readout should be sometime first half next year.

On the balance sheet under other non current liabilities.

We have deferred approximately 18 billion of divestment gains as a provision for that guarantee to the bias.

This will be recognized over the guarantee period subject to the joint Venture's performance in the next few years.

Turning over to page seven.

Speaker #3: Our next generation innovation is very exciting. ATTC programs' first candidate IND filing is coming up very soon, in a month or so. We have more to come later this year.

Our P&L so over all the revenue for the first half of 2025 was $278 million down 10% versus same time last year investment in R&D amounted to $72 million, reflecting multiple nba's MW deal in China.

Speaker #3: And we are also exploring BD activities for not only our ATTC programs but other programs as well. Without further ado, I'll just send it over to the next speaker.

On the bottom line, we have reported a record high net income of $455 million mainly.

Mainly contributed by the partial divestment of our joint venture with Shanghai pharma moving onto the next page.

We have I, just don't our full year revenue guidance to between 270 to 350 million mainly.

Speaker #3: Our CFO, Johnny Cheng, to give you a financial overview. And update Johnny.

Johnny Cheng: On the bottom line, we have reported a record high net income of $455 million, mainly contributed by the partial divestment of our joint venture with Shanghai Pharmaceuticals. Moving on to the next page. We have adjusted down our full-year revenue guidance to between $270 to 350 million, mainly to reflect a revision for the phasing of certain clinical and commercial milestones, and also the delay of sovleplenib commercial launch. I will now pass to our head of commercial, George Yuan, to share with us on the commercial performance.

And they need to reflect a revision for the facing offsetting clinical and commercial milestones.

Speaker #4: Thank you, Dr. Su. On page six, we can see our balance sheet reflects a very strong cash position. Over 1.3 billion in cash resources.

And also the delay of some pent up commercial launch.

I will now pass to our head of commercial George and to share with us on the commercial performance.

Speaker #4: Which includes proceeds from the partial divestment of our joint venture with Shanghai Farm. So these resources will allow us to accelerate global ATTC development.

Thanks, Johnny.

The first half year of <unk>.

Speaker #4: And explore potential investment opportunities. Further down the balance sheet, under no other non-current liabilities, we have deferred approximately $18 million of divestment gains as a provision for profit guarantee to the buyers.

Commercial results is relatively flat.

So its arkla.

Post a very strong growth 25%.

Offset by a weaker China performance.

For three brands grew net surrender and ore passes.

Speaker #4: This will be recognized over the guarantee period, subject to the joint venture's performance in the next few years. Turning over to page seven, our P&L, so over all the revenue for the first half of 2025 was $278 million, down 10% versus same time last year.

George Yuan: Thanks, Johnny. The H1 of our commercial results is relatively flat. FRUZAQLA posted a very strong growth, 25%, but offset by a weaker China performance for three brands, ELUNATE, SULANDA, and ORPATHYS. Next slide. If we look at FRUZAQLA, we know that CRC is the third most common cancer and also the second leading cancer for fatality worldwide. With new countries adding to the launch market and also including reimbursement, we see FRUZAQLA deliver a very strong, solid growth in H1. Especially Japan with Takeda's strength and the know-how in the CRC market, as well as the benefit and the value of FRUZAQLA in CRC being highly recognized by NICE recommendation. These products will continue to gain market share and through the expansion of the reimbursement and the new launch countries. Next slide.

Net sites.

If we look at cruise Arkla windows that CRC is to serve the most common cancer and also the second leading cancer. Therefore, the fatality.

Our wide and with.

Speaker #4: Investment in R&D amounted to $72 million, reflecting multiple NDAs under review in China. On the bottom line, we have reported a record high net income of $455 million.

Your country, adding to the launch market and also include the reimbursement received for <unk>.

They were a very strong solid growth in the first half year.

Especially Japan.

Speaker #4: Many contributed by the partial divestments of our joint venture with Shanghai Farm. Moving on to the next page, we have adjusted down our full year revenue guidance to between $270 to $350 million.

With a cookie does the strength seen in there.

Know how in the CRC Mark as well.

Benefit and the value for <unk> CRC being hybrid a corner there.

Organized by nice recommendation.

These products will continue to gain market share and so the expansion of the reimbursement and the new launch countries.

Speaker #4: Mainly to reflect a revision for the phasing of certain clinical and commercial milestones. And also the delay of surfactant commercial launch. I will now pass to our Head of Commercial, Georgian, to share with us on the commercial performance.

Next slide.

The China CSD market become very competitive in the later line, we see more rigor Philippa generics in the past one or two generic <unk> launched it in the past 12 months also that's a uptake of the combo regimen in the solar <unk> combo.

Speaker #5: Thanks, Johnny. The first half year of our commercial results is relatively flat. For example, post a very strong growth, 25%, but offset by a weaker China performance in for three brands, Illuminate, Surrender, and All Passes.

Become cost luxury might become more popular than before and also we split we will face a final push baidu filipa before the PPP.

George Yuan: The China CRC market become very competitive in the later line. We see more regorafenib generics and the past 1 or 2 generics launched in the past 12 months. Also, there's an uptake of the combo regimen in the third line. Bevac combo, cross line treatment become more popular than before. Also we face a final push by the regorafenib before the VBP. We adjust our market strategy, and we gain back some of the share on the Q2 this year. We still believe we are the strong market leader in the third-line CRC, and we will continue to be the market leader in the CRC. The EMC launch as well as the future RCC approval will further drive our growth. Next slide.

Speaker #5: Next slide. If we look at the for example, we know that CRC is the third most common cancer and also the second leading cancer for the fatality.

And so we adjust our market strategy and we came back some of the Shea on the Q2 loss. This year and we still believe we are a strong market leader in the satellite in CRC and we will continue to be the market leader in the CRC and the yen.

Speaker #5: Worldwide. And with new country adding to the launch market and also include a reimbursement, we see for example, deliver a very strong solid growth in the first half year.

<unk> launch as well as the future RCC approval will further drive our gross.

Yeah.

Speaker #5: Especially Japan, with Takeda's strength and the know-how in the CRC market, as well as the benefit and the value of for example, in CRC being highly recognized by NICE recommendation.

Next slide.

The issue here.

T K R. The mat market went through a strong turbulence with.

Additional four Nadil listed products.

Starting funding yet beginning with all of the four was the first line indication.

Speaker #5: So these products will continue to gain market share and through the expansion of the reimbursement and the new launch countries. Next slide. The China CRC market becomes very competitive in the later line.

Ore passes actually lost some market share in the beginning of the year, but.

George Yuan: This year, the MET market went through a strong turbulence with additional 4 NRDO listed products starting from the year beginning, with all of the 4 with the first-line indication. ORPATHYS actually lost some market share in the beginning of the year, but through the middle of this year, we get a full approval first-line, as well as the SACHI approval before the middle of this year. ORPATHYS has been well-positioned for this year's NRDO renegotiation. Of course, SACHI is certainly the key differentiator versus other TKIs. Also, we will strongly leverage AstraZeneca's expertise in lung cancer. The combo treatment will be the first and the best oral dual precision medicine to offer to the lung cancer patients. Next slide. If we look at the NET market, we also have certain kind of headwinds. We see the octreotide generics launching in the market.

Through the middle of this year, we get full approval firsthand as whereas such approval before the middle of this year.

Speaker #5: We see more redefinable generics and the TAS102 generics launched in the past 12 months. Also, there's an uptake of the combo regimen in the third line, Bayvar combo, become cross-line treatment, become more popular than before, and also we face a final push by the redefinable before the VVP.

Our pockets has been well positioned for this year.

Renegotiation of course Saatchi is certainly the key differentiator versus others. Two cats also we work strongly leverage.

Astrazeneca is our expertise in the lung cancer.

Speaker #5: And so we adjust our market strategy and we gain back some of the share from the Q2 this year. And we still believe we are the strong market leader in the third line CRC and we will continue to be the market leader in the CRC and the EMC launch as well as the future RCC approval will further drive our growth.

Combo treatment will be the first and the best oral do precision medicine to offer to the lung cancer patients.

Next slide.

If we look at that the naphtha market. We also has some kind of headwinds.

We see the.

After real tired of generics.

Launched in the market also we saw this year Leno.

Speaker #5: Next slides. The this year, the MAT TKI, the MAT market went through a strong turbulence with additional four NADL listed products starting from the year beginning.

Tie that game to the RTL and multiple nuclear medicine. The PR Keytruda man is under clinical development, which is a fighting for patient share in the top centers.

We do see a short term hiccup for our business, but if.

Speaker #5: With all of the four, with the first line indication, All Passes actually lost some market share in the beginning of the year. But through the middle of this year, we get a full approval of the first line as well as the such approval before the middle of this year.

George Yuan: Also, we saw this year, Lennon tied again to the NRDO and multiple nuclear medicine, the PRRT treatment, is under clinical development, which is fighting for patient share in the top centers. We do see a short-term hiccup for our business. If we look at the future, we still believe we are the market leader in the TKI segment and we have an obligation to gain the market share for the whole segment as well as SULANDA in the NET treatment. The diagnosis and the know-how, the treatment for the NET is still growing, and we believe there is a lot of education opportunity. As a leader in the TKI segment, we will further drive the category. Next, I will hand over our Michael.

If we look at the future with stupidity, we are the market leader in the <unk> segment, and we have a obligation to gain the market share for the whole segment is whereas the Sudan and the Mets treatment.

The diagnose and no halt the treatment is a fortinet is still growing and we believe there's a lot of education opportunity as a leader in.

Speaker #5: All Passes has been well positioned for this year's NADL renegotiation. Of course, such is certainly the key differentiator versus others TKIs. Also, we will strongly leverage the AstraZeneca's expertise in the lung cancer.

In the acute care segment, we will further drive the category.

Yeah.

Next our hanging over our.

My Cook.

Speaker #5: The combo treatment will be the first and the best oral due precision medicine to offer to the lung cancer patients. Next slides. If we look at the net market, we also have some kind of headwinds we see the Octavio Tide generics launched in the market.

Yes. Thank you George I'm going to give you an update about our pipeline. So we have made tremendous progress in our late stage product development. In addition to that global approval of the <unk>.

CRC for Clinton, and then also expanding into the new indications in China.

Such has been the major cancer and RCC.

Michael Shi: Yeah. Thank you, George. I'm going to give you an update about our pipeline. We have made tremendous progress in our late-stage product development. In addition to the global approval of the CRC, fruquintinib is also expanding into the new indication in China, such as endometrial cancer and RCC. Another brand, savolitinib, also achieved label expansion approval with multiple new indications, in the late-stage development, again, with our partner, AstraZeneca. Dr. Su also mentioned fanregratinib is in the late phase II development with a late phase readout later this year. Our first HMPL-A251 product has metastasis improvement in China with additional new indication development in the follicular lymphoma. Later on, I'll also give you an update on our SYK inhibitor in sovleplenib for NDA and also the WAIHA development. Our third-way product, rinosarinab and fanregratinib, also at a pivotal registration trial stage.

And.

Speaker #5: Also, we saw this year Leno Tide gain to the NADL. And the multiple nuclear medicine, the PRRT treatment is under clinical development. Which is fighting for patient share in the tox centers.

Then another brand save Leatherneck also achieved label expansion approval, but multiple new indications.

In the late stage at the moment again with us.

Astrazeneca.

Dr. Sue Otto mentioned sort of adding it is in the late phase two development with a late phase <unk> readout later this year.

Speaker #5: We do see a short-term hiccup. For our business, but if we look at the future, we still believe we are the market leader in the TKI segment and we have an obligation to gain the market share for the whole segment as well as Surrender in the net treatment.

And our first <unk> product tazemetostat improving in China.

With additional new indication development in the Follicular lymphoma.

Later on I'll also give you an update our spurt sick inhibitor in subtle planet.

For our NDA and also the White Hot development.

Speaker #5: The diagnosis and the know-how of the treatment is for the net is still growing. And we believe there's a lot of education opportunity as a leader in the this in the TKI segment.

And our third wave product arena sit in them and <unk> got in there.

Also at a pivotal registration trial stage.

All of these product profile.

Speaker #5: We will further drive the category. Next, I will hand over our Michael.

Propel our future growth.

Next slide.

And.

This slides also give you an update on our early stage pipeline advancing.

Speaker #6: Yeah, thank you, George. I'm going to give you an update about our pipeline so we have made tremendous progress in our late-stage product development.

Or will be entered into the clinical development first.

768 is our third generation PDK editor.

Speaker #6: In addition to the global approval of the CRC, frequently also expanding into the new indication in China. Such in the major cancer and RCC.

Michael Shi: All these products will propel our future growth. Next slide. This slide also gives you an update about our early-stage pipeline advancing or will be entered into the clinical development first. 760 is our third-generation BTK inhibitor. Currently, it's still in the phase II development in the refractory DLBCL. Our new menin inhibitor, 506, also entered a clinical development. It's in dose escalation stage in the AML. Also, today, I'm going to give you updates, some of our new class of agent. Dr. Xu mentioned the ATTC, Antibody-Targeted Therapy Conjugate product. 3 early pipeline, A251, 580, and A30, will all enter clinical development later this year and also next year. Next slide. Here's our update about the ATTC platform. During the last conference call, we disclosed our new platform.

Currently its still in the phase two development in diary refractory the L. P C L.

And our new.

Men inhibitor.

Speaker #6: And our then another brand, salvaging it also achieved label expansion approval with multiple new indications. In the late-stage development. Again, with our partner AstraZeneca.

Oh six also entered a clinical development is in dose escalation stage.

In the AML.

Oh, so today I'm going to give you update some of our new class of the agent Dr. Sue mentioned, the ATT C and antibody targets therapy congregate product.

Speaker #6: Dr. Su also mentioned surfactant is in the late phase two development with late-phase readout later this year. And our first hint product has metastatic been approved in China.

Three early pipeline.

8251.

Fighting a D and a 30.

Speaker #6: With additional new indication development in the follicle lymphoma. Later on, I'll also give you an update on our sick inhibitor in several planet. For NDA and also the Wiha development.

Well all enter clinical development later this year and also next year next slide.

Here's our update about a DTC platform.

Speaker #6: And our third way product Renacitinib and Phenergradinib. Also at a pivotal registration trial stage. All these products will profile our future growth. Next slide.

During the last conference call with Us.

Disclose our new platform.

And so now we're actually making pretty advanced progress in our first three molecule and are targeting.

Targeting enter clinic up pretty soon.

Speaker #6: And this slide also gives you an update about our early-stage pipeline, which is advancing and will be entering clinical development. First, 760 is our third-generation BDK inhibitor.

And so.

I think the ETT C.

Several key differentiation showing here.

Michael Shi: Now we're actually making pretty advanced progress in our first three molecule and all targeting enter clinical pretty soon. I think the ATTC have several key differentiation shown here because we really leverage and maximize the synergy between the target therapy antibody and also our small molecule know-how as a payload, and really through the linker optimization to really overcome some of these physical chemical property of small molecule as a payload. By doing that, it could have a better efficacy through antibody and small molecule combination while target specific mutation can overcome drug-resistant and potentially support a combination with other target therapy, particularly in the frontline setting, and also improve the safety given the low on-target and off-tumor toxicity than the small molecule. Unlike other toxin-based ADC, it has less myelosuppression and also have a better quality of life.

Because we really leverage and maximize the synergy between them.

Speaker #6: Currently still in the phase two development in the refractory DLBCL. And our new men inhibitor 506 also entered the clinical development. It's in those escalation stage.

That target therapy antibody and also our small molecule no hall as.

As a payload and really through the linker off the amortization to really overcome some of these Phil.

Physical chemical property of small molecule is a payroll.

Speaker #6: In the AML. Also, today I'm going to give you an date some of our new class of agent, Dr. Su mentioned the ATTC and antibody targets therapy conjugate product.

And so by doing that.

It could have a better efficacy with antibody small molecule combination.

Target specific mutation can overcome drug resistant and pull down a tree to support a combination with other targeted therapy, particularly in the frontline setting.

Speaker #6: Three early pipeline A251, 580 and the A30 will all enter clinical development later this year and also next year. Next slide. Here's our update about ATTC platform.

And also improve the safety given the low target on target off tumor toxicity than the small molecule.

And also unlike other toxin based ADC has less myeloid suppression and also have a better quality device.

Speaker #6: You know, during the last conference call, we disclosed our new platform. And so now we are actually making pretty advanced progress in our first three molecules.

And also have a favorable pharmacokinetic profile, resulting from antibody guided deliberated the target sites.

Improve the bioavailability and reduced drug drug interaction compared to oral small molecule. Okay next.

Speaker #6: And all targeting entered clinical pretty soon. And so I think the ATTC have several key differentiations shown here. Because we really leverage and maximize the synergy between the targets therapy antibody and also our small molecule know-how as a payload.

Next slide.

So <unk>.

<unk>.

The a T D C. It can target protein require blood cancer growth.

Michael Shi: Also have a favorable pharmacokinetic profile resulting from antibody guided delivery to the target sites, improve the bioavailability, and reduce drug-drug interaction compared to our small molecule TKI. Next slide. Mechanistically, the ATTC can target protein required for cancer growth. It has a synergistic effect with the combination with functional antibody and also has the ability to combine with other chemo target therapy or standard of care chemotherapy, which is particularly important in the frontline setting. There are numerous report the chemo-based ADC is working less effectively with the tumors with driver mutations. This will have the opportunity to really establish a better therapeutic window and through the reduction on target and off-tumor toxicity. It have less other compound-induced toxicity such as liver QT, lung QT, et cetera.

And it has a synergistic effect with the combination with functional antibody and also has the ability to combine with other chemo target therapy or set of care.

Chemotherapy.

And Richard particularly importance in the frontline setting and.

Speaker #6: And really through the linker of the optimization to really overcome some of these physical chemical properties of small molecules as a payload. And so by doing that, it could have better efficacy through antibody and small molecule combination.

Also there are numerous report the chemo based ADC.

Working less effectively with the tumors with <unk> mutations so.

This will have the opportunity.

<unk> really establish a better therapeutic window and sort of the reduction on target on tumor toxicity and.

Speaker #6: Well, target specific mutation. Can overcome drug resistant and potentially support a combination with other target therapy. Particularly in the front line setting. And also improve the safety given the low target untarget and off tumor toxicity than the small molecule.

And also.

We have other unless other compounding induced toxicities, such as member Judy Leung Judy et cetera.

So it can be those long term was to improve the safety window and with a reduced systemic toxicity of our small molecule.

Speaker #6: And also unlike other toxin-based ADC, it has less mild suppression and also have a better quality of life. And also have a favorable pharmacokinetic profile resulting from antibody-guided delivery to the target site.

And more generally but to a DTC platform can also be expand to incorporate high molecule Hawaii dropped a payload. So this actually is.

Speaker #6: Improve the bioavailability and reduce drug-drug interaction compared to our small molecule TKI. Next slide. So mechanistically, the ATTC can target protein required for a cancer growth.

Our platform to have multiple opportunity next life.

Michael Shi: It can be dosed long-term with improved safety window and with a reduced systemic toxicity over small molecule. More generally, the ATTC platform can also be expanded to incorporate high molecular weight drug payload. This is actually is a platform to have multiple opportunity. Next slide. This is the design of our first ATTC candidate, HMPL-A251. On the antibody side, it use a clinically proven, well-established humanized and IgG1 antibody and with a small molecule payload with a drug-to-antibody ratio of 4. For the proof of concept of this platform and the antigen we selected is expressed in multiple tumor type, and the antibody is internalized favorably.

So this is the design of our first a T T C candidate.

8% to five one so.

So on the antibody side is you as a clinically proven and well established humor.

Speaker #6: It has a synergistic effect with a combination with functional antibody. And also has the ability to combine with other chemo target therapy or center of care chemotherapy.

And.

Our <unk>, one antibody and with a small molecule payloads.

And with that drug to antibody ratio up four.

Speaker #6: And which is particularly important in the front-line setting. Also, there are numerous reports that chemo-based ADCs are working less effectively with tumors with dry mutations.

For the proof of concept of this platform and the and the gym. We selected is expressed in multiple tumor type and the antibodies internalize that favor of late.

On the pillow site.

Speaker #6: So this will have the opportunity to really establish a better therapeutic window. And through the reduction of untarget and all tumor toxicity. And also it have other less other compound-induced toxicity such as liver, QT, lung QT, etc.

It really leverage all small molecule expertise and with a highly potent.

Against kinase family, but it's broader genetic alteration and has the potential to synergize busy antibody to overcome resistance and the improved the app.

Let's see.

We are also showing some of the bystander you faster kill the antigen negative itself and also on the linker signed.

Michael Shi: On the payload side, it really leverage our small molecule expertise and with a highly potent against kinase family with 4 genetic alteration, and has the potential to synergize with the antibody to overcome resistance and improve the efficacy. We also show you some of the bystander effect to kill the antigen-negative cells. Also on the linker side, it has a pretty stable in the plasma, and it will be cleaved by the protease highly expressed in the cancer cell, so have a very precise target delivery in the tumor cells. Next slide. This slide shows some of the preclinical data for HMPL-A251. In a panel of the tumor cells, we actually see a very potent activity with a sub-nanomolar range of IC50 for tumor cell lines with a high antigen expression. In the middle figure, it shows the bystander effect.

Speaker #6: So it can be those long-term with an improved safety window and with a reduced systemic toxicity for small molecules. More generally, the ATTC platform can also be expanded.

It has a pretty stable in the plasma and it will be clear by the Proteus highly expressed in the cancer itself. So.

Have a very precise target deliberate in the tumor cells.

Speaker #6: To incorporate high molecular weight drug payload. So this is actually it's a platform to have multiple opportunity. Next slide. So this is the design of our first ATTC candidate.

Next slide.

And this slide shows some of the preclinical data for <unk> one.

In a panel of that tumor cells, we actually see.

Very potent.

Activity was a subnormal level range of IC 54.

Speaker #6: A251. So on our antibody side, is use a clinical proven well-established humanized and IGG1 antibody. And with a small molecule payload with a drug to antibody ratio of four.

First tumor cell lines with the high end of gene expression and in the middle finger is shows.

Bystander effect for energy express tumor cells it has to.

Pretty good the tumor, killing but low or no expressed.

Speaker #6: For the proof of concept of this platform and the antigen we selected is expressed in multiple tumor types. And the antibody is internalized a favor of.

And again right.

The.

Uh huh.

<unk> has no antitumor activity by if you're co culture.

Speaker #6: And on the payload side, it really leverage our small molecule expertise and with a highly potent against kinase family with sporadic genetic alteration. And has the potential to synergize with the antibody to overcome resistance and improve the efficacy.

And is it positive or negative cells actually helped.

Michael Shi: For antigen-expressed tumor cells, it has pretty good tumor killing, but low or no expressed antigen. The A251 has no antitumor activity. If you co-culture the antigen positive and negative cells, it actually have the activity to kill both the negative and the positive cells. It really demonstrate the bystander effect. Also it preserve the ADCC activities, same as the naked antigen antibody showing on the right-hand side figure here. Next slide. This is a preclinical proof of concept for our A251. The target antibody is linked to a target therapy payload with a special linker. The left figure shown here is the target line antibody showing green and the small molecule payload showing red here with a bi-weekly dosing. It shows tumor growth inhibition.

Activity to kill to bolster.

And the positive itself. So it really demonstrate the bystander effect and also preserve the.

The ADT ADC activities are same as the naked antigen antibody showing on the right handset figure here.

Speaker #6: We also show some of the bystander effect to kill the antigen negative cells. And also on the linker side, it has a pretty stable in the plasma.

Next slide.

Speaker #6: And it will be cleared by the protease highly expressed in the cancer cell. So have a very precise target delivery in the tumor cells.

And this is a proof.

Our preclinical proof of concept for our eight to five one.

The targeted antibody is linked to target therapy payload is a special linker and the left figure shown here is the target one antibody shown in green and the small molecule.

Speaker #6: Next slide. And this slide shows some of the preclinical data for A251. In a panel of the tumor cells, we actually see a very potent activity with a sub-nanomolar range of IC50.

Payload.

With that.

Showing rep here with a biweekly dosing and a chosen tumor growth inhibition.

Speaker #6: For first tumor cell lines with a high energy expression. And in the middle figure, it shows the bystander effect for antigen expressed tumor cells.

And also the single dose target one and.

D C. A shows the robots and a tumor activity compared with the antibody alone or in small molecule halo alone or the combination bowls.

Speaker #6: It has the pretty good tumor killing. But low or no expressed antigen, right? The A251 has no anti-tumor activity. But if you co-culture the antigen positive and negative cells, it actually has the activity to kill both the negative and the positive cells.

Payload and.

Antibody. So this is very important proof of concept showing a single dose of 80 D. C deliver a sustained the tumor inhibition over 14 day period of time and show good Tolerability.

Michael Shi: Also the single dose of target 1 and ATTC shows a robust and a tumor activity compared with the antibody alone, or the small molecule payload alone, or the combination of both payload and antibody. This is very important proof of concept showing a single dose ATTC deliver a sustained tumor inhibition over 14-day period of time and show good tolerability. On the right-hand side, we can see the payload itself, or payload plus antibody, although have an anti-tumor effect, but they also reduce the body weight. The A251 itself, dosed at 30 mg/kg, has no weight loss. It's very important show not only induce that tumor regression, but also have a very good safety profile. Next slide. The A251 also show very good synergistic activity with the standard of chemotherapy. The left panel here is the tumor xenograft model.

Because on the right hand side.

You can see the payload itself, our payload plus antibody.

Speaker #6: So it really demonstrates the bystander effect. And also it preserves the ADCC activity same as the naked antigen antibody showing on the right-hand figure here.

Although have under tumor effect, but they're also reduced body weight.

But the 8% to <unk> yourself those at the 30 milligram per kilogram.

Have no weight loss. So it's very important show not only induce that tumor.

Tumor regression, but also have a very good safety profile next slide.

Speaker #6: Next slide. And this is a proof of concept preclinical proof of concept for our A251. The target antibody is linked to a target therapy payload with a special linker.

Okay.

And also.

<unk> also shown very good synergy activity.

It's a standup chemotherapy the left panel here is that tumors graph model.

Speaker #6: And the left figure shown here is the target one antibody showing in green and the small molecule payload with the showing red here with a bi-weekly dosing.

The combo with chemo.

Sure.

A synergistic effect.

And also on the right hand side, we have seen that tumor cell lines study also showed that chemotherapy plus 8% to Taiwan.

Speaker #6: And it shows tumor growth inhibition. Additionally, the single dose of Target One and ADTC demonstrates robust anti-tumor activity compared with the antibody alone or the small molecule payload alone.

Synergist activity. So this is quite different from the other Thompson base ADC because in the all other clinical debarment setting you can see.

Michael Shi: The combo with chemo show a synergistic effect. Also on the right-hand side, we have seen the tumor cell line study also show the chemotherapy plus A251 have a synergistic activity. This is quite different from the other toxin-based ADC because in all the clinical development setting, you can see most of the toxin-based ADC cannot actually combine with the standard of care because the toxicity. Okay, next slide. I'm going to highlight some of the progress on our key asset, savolitinib, and both in the global and the China development are really going to drive the future growth. At the ELCC 2025, AZ reported the data for SAVANNAH study and showing the durable overall response rate.

Speaker #6: Or the combination of both payload and antibody. So this is very important proof of concept showing a single dose ATTC deliver a sustained tumor inhibition over 14-day period of time.

Most of the ADC.

Toxin based ADC cannot actually combined with the standup appear because.

The toxicity, Okay next slide.

Also.

Speaker #6: And show good tolerability. Because on the right-hand side, we can see the payload itself or payload plus antibody although have an under-tumor effect, but they also reduce the body weight.

I'm going to highlight some of the progress.

Sure.

The key asset Saba live in that.

And that both in the global and the China them all of them are really going to drive the future growth.

So at the LCC 2025, we have to report the data.

Speaker #6: But the A251 itself those at the 30 milligram per kilogram has no weight loss. So it's very important to show not only induce that tumor regression but also have a very good safety profile.

AZ reported the data for Savannah study and showing the durable response or response rate.

And in the same conference we also show the.

Speaker #6: Next slide. And also the A251 also show very good synergistic activity with the standard chemotherapy the left panel here is the tumor xenograft model.

Our stable Internet in Madison with 2014.

Speaking of skipping non small cell lung cancer.

Also show there.

Very good response rate and also the sustained over a survival. So this also lead to our approval not only for our profile for Leigh Leigh Medicine, 2014, and non small cell lung cancer indication, but also expand the first line indication.

Speaker #6: The combo with chemo shows a synergistic effect. Also, on the right-hand side, we have seen the tumor cell line study show that chemotherapy plus A251 has synergistic activity.

Michael Shi: In the same conference, we also show our savolitinib in MET exon 14, skipping non-small cell lung cancer also show a very good response rate and also the sustained overall survival. This also lead to our approval, not only get a full approval for late-line MET exon 14 non-small cell lung cancer indication, but also expand the first-line indication. Very importantly, George also mentioned about our second-line EGFR TKI-refractory patients, savolitinib plus osimertinib in MET-amplified patient. This one we achieved NMPA approval in June, and also has been selected in the ASCO presentation during the annual ASCO meeting. Dr. Su mentioned our pRCC, the SAMETA trial, will also finish the recruitment, and the readout for this trial will be early next year. For the China side, we also achieved the recruitment for the SANOVO first-line trial, and also we're trying to finish the SAFFRON trial recruitment this year.

Very importantly, George also mentioned about second line Egfr Teekay <unk> refractory patients.

Speaker #6: So this is quite different from the other toxin-based ADC because in the all the clinical development setting ou can see most of the ADC toxin-based ADC cannot actually combine with the standard procure because the toxicity.

A passage Plaza awesome burden there.

<unk> amplified patient this one we achieved.

<unk> approval in the June and also.

Has been selected and the <unk> presentation.

Speaker #6: Okay, next slide. Also, I'm going to highlight some of the progress on our the key asset salvaging it. And both in the global and the China development, really going to drive the future growth.

During the annual <unk> meeting.

Dr Sue mentioned our.

PRC feed a <unk> trial.

Okay.

Also finished recruitment and.

The readout for.

This trial will be early next year and for the China side, We also achieved.

Speaker #6: So at the ELCC 2025, we have reported the data for AC reported the data for Savannah study and showing the durable response overall response rate.

Recruitment for this novel first line trial and also we're playing.

Trying to finish that sovereign trial.

Speaker #6: And in the same conference, we also show the our salvaging it in medicine 14 speaking skipping non-small cell lung cancer. Also show a very good response rate and also the sustained overall survival.

Recruitment this year and the gastric cancer in Madden amplified patients also are preparing NDA file later this year next one.

This is also showing the key results for Saatchi trial and in the overall intent to treat patient population.

Speaker #6: So this also lead to our approval not only get a full approval for ley line medicine 14 non-small cell lung cancer indication, but also expand the first line indication.

The PFS Oc plus shovel is in there.

Michael Shi: The gastric cancer in MET-amplified patients also are preparing NDA for later this year. Next slide. This is also showing the key results for SACHI trial. In the overall intent to treat patient population, the PFS of Osi plus savolitinib, which has a hazard ratio of 0.34, and the PFS improvement versus chemo from 4.5 to 8.2 months. Also, regardless the first, second generation TKI treatment or prior third-line TKI progressed patient, the hazard ratio is very consistent. In particular, for third-generation TKI refractory patient, as you can see, the control chemo arm only have a PFS of 3 months. The savo plus Osi reached the PFS almost 7 months. Also, the response rate, disease control rate, and durability of response also has been extended by Osi plus savo combination. Next slide.

Richard.

Has a ratio of <unk>, three four and the PFS improvement versus chemo from four five to $8 two months.

Speaker #6: Very importantly, George also mentioned about our second line EGFR TKI refractory patients. All passes plus osimertinib in that amplified patient this one we achieved the NMP approval in June.

And also regardless stuff first second generation PKI treatment or prior <unk> cheaper.

Progressed a patient.

The hazard ratio is very consistent and in particular for third generation <unk> refractory patient as you can see.

Speaker #6: And also has been selected in the ASCO presentation during the annual ASCO meeting. Dr. Su mentioned our PRCC the Samita trial will also finish the also finish the recruitment and the readout for this trial will be early next year.

The control chemo arm have only have a PFS of three months and the sabo fast Oc reached the PFS almost seven months and also.

The response rate disease control rate and durability of response also has been extended by all seaport subtle combination next slide.

Speaker #6: And for the China side, we also achieved the recruitment for the Sanovo first line trial. And also we're playing trying to finish the saffron trial recruitment this year.

And interestingly, we also observed.

The publication for it.

And we've added that in.

<unk> posted two trial as you recall, the Ami plus chemo versus chemo trial. They also have a biomarker subgroup analysis.

Speaker #6: And the gastric cancer in med amplified patients also are preparing NDA for later this year. Next slide. This is also showing the key results for Suchi trial.

Matt amplified patients only to identify about 40% of the patients in.

Michael Shi: Interestingly, we also observed the publication for amivantamab in the MARIPOSA-2 trial, as you recall, the ami plus chemo versus chemo trial. They also have a biomarker subgroup analysis. MET-amplified patients only identify about 40% of the patients in the MARIPOSA-2 trial. Unlike our study for SACHI, we observe about 30% of the MET amplification by FISH analysis. So in the patient population, as you can see, the chemo arm, actually both trials, the MARIPOSA-2 and the SACHI trial, are very consistent. Remember, these are patients have MET amplification, progressed on the prior third-generation TKI. Amivantamab trial showing the PFS of 3.1 months, but their improvement is only to 4.4 months PFS with a hazard ratio of 0.51. So the patient population in this population, what we can conclude, just like the SACHI, MET-amplified patients have very poor prognosis. Their PFS only 3 months.

In the marrow posted two trial and unlike our.

Speaker #6: And in the overall intent to treat patient population, the PFS are all C plus salvaging it which is a hazard ratio of 0.34. And the PFS improvement versus chemo from 4.5 to 8.2 a month.

Our study for Saatchi, we also are about 50%, 30% of the met amplification by fish analysis.

And.

So in the in the patient population as you can see the chemo arm actually both trial <unk> II and the Sochi trial, a very good system I remember these are patients that have a massive amplification progress on the prior third generation PKI and Emmy bad in that trial.

Speaker #6: And also regardless, the first, second generation TKI treatment or prior third line TKI progress the patient the hazard io is very consistent. And in particular for third generation TKI refractory patient, as you can see, the control chemo RN have only have a PFS three months.

Showing that PFS of $3, one month, but their improvement is only 244 months PFS with a hazard ratio of <unk>. So.

Speaker #6: And the salvo plus OC reached the PFS almost seven months. And also the response rate disease control rate and durability of response also has been extended by all OC plus salvo combination.

The patient population in this population, where we can conclude just like the Sochi, Matt amplified patients have very poor prognosis, there PFS only three months.

But save limit of pluses Aussie reached the PFS almost summer months.

Speaker #6: Next slide. And the interestingly, we also observed the publication for Amivandinib and the in the marriage posted two trial, as you recall, the Amiplast chemo versus chemo trial.

Is it reasonable 0.32.

So this is quite significant difference because we believe in the biomarker selected patient population.

Sowell, plus obviously really demand surprise, so pure activity.

Really addressing these are patients with a profile of the mall types and also bolster Savannah in Sochi trial demonstrate.

Speaker #6: They also have a biomarker subgroup analysis. Med amplified patients only identify about 40% of the patients in the marriage posted two trial. And unlike our study for Suchi, we observe about 30% of the med amplification by FISH analysis.

Michael Shi: Savolitinib plus Osi reached the PFS almost 7 months with a hazard ratio of 0.32. This is quite significant difference. We believe in the biomarker-selected patient population, savo plus Osi really demonstrates superior activity, really addressing these patient with poor prognosis. Both the SAVANNAH and SACHI trial demonstrate the combo has a very effective effect in the patient with the baseline brain metastases. These are the key difference between the Osi plus savo compared with other study, because this is the only biomarker-selected patient population, and also with the only chemo-free regimen. We believe this will have a very substantial usage in the clinical setting. Yeah. Next slide. The SACHI approval, I also want to mention, they enable us to go through the NRDL negotiation this year.

Hung Bull has.

Very effective in fact in the patient with baseline <unk> bring my processes. So these are the.

Key difference between.

Sure.

The Aussie plus shovel compare with other study because this is the only biomarker selected patient population and also the only chemo free regimen. So we believe this will have a very.

Speaker #6: And so in the patient population, as you can see, the chemo arm actually both trial the marriage posted two and the Suchi trial are very consistent.

Speaker #6: And remember, these are patients who have experienced a median amplification and progressed on the prior third-generation TKI. The Amivandinib trial showed a progression-free survival (PFS) of 3.1 months.

Central you at Ash.

In the clinical setting, yes next slide.

And the Sochi approval I also want to mention that enable us to go through that and the RDR.

Speaker #6: But their improvement is only to 4.4 months PFS with a hazard ratio of 0.51. So the patient population in this population where we can conclude just like the Suchi med amplified patient have a very poor prognosis, their PFS only three months.

Nicole.

Asia this year.

And also we present a hour.

Some of it in that medicine 14 trial.

At the VLCC and we have officer very substantial improvement of <unk>. So the patients with a prior treated with <unk>.

Speaker #6: But salvaging it plus OC reached the PFS almost seven months with a hazard ratio 0.32. So this is quite significant difference. We believe in the biomarker selected patient population salvo plus OC really demonstrates superior activity really addressing these patients with a poor prognosis.

Ah patients.

As the OSI 25 months and the patient with the frontline setting.

Michael Shi: Also, we present our savolitinib METIS-14 trial at the ELCC, and we have observed very substantial improvement of OS. The patients with the prior treated with patients with OS of 25 months, and the patient with the frontline setting, the treatment-naive patient, the OS with the long follow-up have OS with 28 months, and the upper level has still not been reached. Among all the MET TKI, the savolitinib actually demonstrate the longest overall survival repeated so far. We are very excited about this data. Next slide. Also, fruquintinib has been extending into the other indications. We already got an early approval for the individual trial. We have the overall response rate of 35%, and also the median PFS reached 9.5 months.

Treatment naive patients the OLS with a long follow up.

OS was 28 months and the upper level has still not been reached so among all the Mad PKI.

Speaker #6: Both the Savannah and the Suchi trials demonstrate that the combination has a very effective impact on patients with baseline brain metastases.

The <unk> actually demonstrate the longest over survival repeat it so far so they're very excited about this data next.

Next slide.

Speaker #6: So these are the key difference between the OC plus salvo compared with other study because this is the only biomarker selected patient population and also with the only chemo free regimen.

And.

Also <unk> has been extending into other indications so.

We already got the early approval for the in a mutual trial.

We have the overall response rate of 35.

Speaker #6: So we believe this will have a very substantial usage in the clinical setting. Yeah, next slide. And the Suchi approval, I also want to mention that enable us to go through the NRDL negotiation this year.

Percent and also the medium PFS reached nine five months.

And we are also going to present, our phase III.

<unk> got two trial.

Upcoming.

East mode later, this year and showcased.

Speaker #6: And also we presented our salvaging it medicine 14 trial at the ELCC. And we have observed very substantial improvement of OS. So the patients with a prior treated with patients with OS of 25 months.

Activity has been chosen as a meaningful or a presentation. So we'll highlight the data and the NDA has already been exercise it and under review at the MTA.

Michael Shi: We are also going to present our Phase III FRESCO-2 trial at the upcoming ESMO later this year and showcase the activity that's been chosen as a meaningful oral presentation. We'll highlight the data. The NDA has already been accepted and under review at the NMPA. Next slide. Our first hematological product tazemetostat also get the third-line follicular lymphoma approval. It showed a high consistency with the global trial. At the EHA this year, we showed the patient in the third-line follicular lymphoma with the ORR overall response rate of 63.6%, and the investigator assess the ORR with 68%. It's very consistent with the global trial leading to the approval in the US and Japan. Next slide. Surufatinib is our combination study in the pancreatic cancer is going very well. Pancreatic cancer is a highly deadly disease.

Next slide.

Our first sight hematology product Tazemetostat has also got the third line Follicular lymphoma approval in <unk>.

Speaker #6: And the patient with the front line setting, the treatment naive patient, the OS with a long follow-up have an OS with 28 months and the upper level has still not been reached.

So the high consistency with a global trial and.

So at <unk>. This year, we showed the patients in the third line Follicular lymphoma with the IRC overall response rate of 63 six.

Speaker #6: So among all the med TKI, the salvaging it actually demonstrate the longest overall survival repeated. And so far. So we're very excited about this data.

And the percent and invest in our SaaS. The arb is 68% so it's.

It's very consistent with a global trial, leading to the approval in the U S and Japan.

Speaker #6: Next slide. And also frequently it has been extending into the other indication. So we already get earlier approval for the intermediate trial we have the over response rate of 35% and also the median PFS reached 9.5 months.

Next slide.

<unk> is.

Is.

Our combination study.

In the Penn Gravitate cancer is coming very well pancreatic cancer is a highly deadly disease is have a five year survival rate of less than 13%.

Speaker #6: And we are also going present our phase three Fusica two trial at the upcoming Eastmoat later this year. And showcase the activity has been chosen as a meaningful oral presentation.

In general the Pea.

He is a cold tumor immune cold tumor and now respond to it very well is the immunotherapy.

From our preclinical work on the <unk> study, we actually have demonstrated.

Speaker #6: So we'll highlight the data and the NDA has already been accepted. And under review at the MMPA. Next slide. Our first hematological product test metastats also get the third line follicular lymphoma approval.

Michael Shi: It has a 5-year survival rate of less than 13%. In general, the PDAC is a cold tumor, immune cold tumor, and now responsive very well with the immunotherapy. From our preclinical work and the IT study, we actually demonstrate surufatinib as a VEGF inhibitor, not only inhibited the VEGF, and FGFR pathway, but the CSF1R inhibitor pathway also has an immunomodulating function. There's a phase II/III trial currently ongoing in combination camrelizumab PD-1 and the chemotherapy for the treatment of rePDAC. This will, at the ASCO 2025, the investigator initiative trial also show there's surufatinib, camrelizumab, with a chemotherapy in the first line, demonstrate over ORR 51% versus 24% of Fipemo. There's a significant improvement of the PFS. The phase II portion of this trial is going to read out later this year.

So we're finding that as a VEGF inhibitor not only.

He inhibited diverge of FGF pathway by the <unk> inhibitor pathway also has the emo immuno modulating functions. So theres a phase two three trial currently ongoing.

Speaker #6: It showed the high consistency with the global trial. And so at the EHA this year, we showed the patient in the third line follicular lymphoma with the IRC over response rate of 63.6.

Combination with <unk> PD, one and the chemotherapy for the treatment naive PD IC.

So this will.

At the <unk> 2025 invest.

The investigator initiated trial Oshell shull.

Speaker #6: And the percent. And the invest here are assessed the ORR with 68%. So it's y consistent with the global trial leading to the approval in the US and Japan.

Through a pause parallelism mab.

Yeah.

Ah chemotherapy in first line demonstrated over.

Our 51% business, 24% of it PMO and also there is a significant improvement of the PFS. So the phase II portion of this trial is going to read out later this year.

Speaker #6: Next slide. Surfactant is our combination study in the pancreatic cancer is gone very well. Pancreatic cancer is a highly deadly disease. It's have a five-year survival rate of less than 13%.

What triggers it.

If the results good what triggered the decision making to the phase III portion of the trial.

Next slide.

Also I'm going to give you an update about the.

Speaker #6: In general, the PDAC is a co-tumor immune co-tumor. And now responsive very well with the immune therapy. From our preclinical work and the IT study, we actually demonstrate the surfactant as a vegetative inhibitor not only inhibited the vegetative FGFR pathway, but the CS1R inhibitor pathway also has an immunomodulating function.

Islam One study so we presented the data at <unk> last year demonstrate our robust over a response rate of 71% and that Europe response, 48%, so because of the dual mechanism not only.

Michael Shi: What will trigger, if the results good, will trigger the decision-making to the phase III portion of the trial. Next slide. I'm going to give you an update about the ISL1 study. We presented the data at the EHA last year, demonstrate a robust overall response rate of 71% and the durable response 48%. Because the dual mechanism not only inhibited the macrophage digestion, but also stimulating inhibited B-cell production. The dual mechanism of SYK inhibition really provide advantage, particularly in patients who are refractory to TPO-RA treatment. During the review course, as you recall, we submitted NDA, and the NMPA stipulated there's a lower impurity limit. This requires further CMC validation and stability tests. We target resubmit with the additional data, in H1 2026, and with additional rolling data will be later part of 2026.

Inhibiting macrophage digestion, but also stimulate.

At inhibiting.

Inhibitors b cell production. So the dual mechanism of <unk> inhibition really provide a bondage, particularly in patients who are refractory that <unk> treatment.

Speaker #6: So this is a Phase 2/3 trial currently ongoing, in combination with Charisma PD-1 and chemotherapy for treatment-naive PDAC. This will be presented at ASCO 2025. The investigator-initiated trial will also show the results of Charisma with chemotherapy in the first line.

During the review of course as you recall, we submitted NDA.

Okay.

In short the limit. So this require further CMC validation stability test so.

We target resubmit this additional data.

Speaker #6: Demonstrate the over OR 51% with a 24% of chemo. And also there's a significant improvement of the PFS. So the phase two portion of the trial is going to read out later this year.

In the first half.

Next year of 2026 and with additional Rolling data will be next later part of next year. So.

Here's the update of our subtle planet.

Speaker #6: What will trigger if the results good will trigger the decision making to the phase three portion of the trial. Next slide. Also, I'm going give you an update about the Eastmoat one study.

ITB NDA status and next slide.

And we also have another trial win warm autoimmune hemolytic anemia.

Phase III trial.

We have shown previously that subtle planet each of the overall response rate of 66% and the dura bright spots somebody 7% because that why highs.

Speaker #6: So we presented the data at the EHA last year demonstrated robust over response rate of 71% and the durable response 48%. So because the dual mechanism not only inhibited the macrophage digestion but also stimulating inhibited B cell production.

Michael Shi: Here is the update of our sovleplenib in the ITP NDA status. Next slide. We also have another trial with warm autoimmune hemolytic anemia, the phase III trial. We have shown previously that sovleplenib reached the overall response rate of 66% and the durable response 77%, because the WAIHA is a very deadly disease, and no target therapy has been approved, so represent a high unmet need. We are very excited that phase III registration trial has already completed recruitment, with the data read out next year. I think we make a very strong progress in the R&D, and we're really hoping our R&D team with our novel ATTC platform will develop new treatment modality for the new development. Our late-stage pipeline will advance and propel for future growth. With that, I'll turn to Dr. Su.

Very deadly disease.

No targeted therapies.

So represent a high.

So we are.

Very excited that phase III registration trial has already completed rate movement.

Recruitment with a data readout next year.

Speaker #6: So the dual mechanism of sick inhibition really provide advantage particularly in patients who are refractory to T4 TFRA treatment. During the review course, as you recall, we submitted NDA and the MMPA stimulated a lower impurity limit.

I think we make a very strong progress.

The R&D.

We're really hoping our R&D.

With our novel ADC platform, well develop new treatment modality.

Speaker #6: So this requires further CMC validation and stability test. So we target resubmit with the additional data in the first half next year 2026. And with additional rolling data will be next later part of the next year.

For the for the new development and our late stage product line, well advantaged and propelling for future growth and so with that I will turn to Dr. Xu.

Thank you Mike.

And also thank all speakers for the update.

Before we get onto the Q&A I just want to highlight.

Speaker #6: So here's the update of our subtle planet in the ITP and DA status. And next slide. And we also have another trial with warm autoimmune hemolytic anemia.

Does it give you pause.

Some up.

So in the first half of 2025, we completed <unk> appeal.

Weiguo Su: Thank you, Michael, and also thank all speakers for the update. Before we get onto the Q&A, I just want to highlight, give you a sum up. In the H1 2025, we completed SHPL partial divestment with the proceeding of over $600 million. We also worked on two major products, savolitinib and fruquintinib, in an effort to expand their indications. For savolitinib, we obtained the SACHI approval in second-line EGFR-mutant non-small cell lung cancer with MET amplification. We anticipate following the treatment with third-generation EGFR TKI, about one-third of patients will develop resistance due to MET amplification. The approval of this combination, savolitinib plus osimertinib, offers a treatment potential for these patients. MET amplification, as we know, is a driver, and these patients do very poorly on standard chemo.

Partial divestment.

Speaker #6: The phase three trial we have shown previously the subtle planet reached the overall response rate of 66%. And the durable response 77%. Because the Wiha is a very deadly disease.

With a preceding of over $600 million.

We also worked.

On two major products <unk> Quintin hip.

Speaker #6: And no target therapy has been approved. So represent a high need. So we are very excited that phase three registration trial has already completed removement recruitment and with the data readout next year.

In an effort to expand the indications.

Well, it's in it we achieved.

Obtaining the Sochi approval in second line Egfr mutant non small cell lung cancer with met amplification.

Anticipated.

Speaker #6: So I think we make a very strong progress. In the R&D and we really hoping our R&D team with our novel ADTC platform will develop new treatment modality for the for the new development.

Following the treatment with third generation Egfr TPI.

One third of patients will develop resistance due to met amplification. So this combination to approval of this combination.

Speaker #6: And our late stage prop line will advance and propel for future growth. And so with that, I'll turn to Dr. Su. Yeah.

Lithium plus automotive offers.

The treatment potential for these patients and met amplification as we know is that.

Speaker #7: Thank you, Mike. And also thank all speakers for the update. Before we get on to the Q&A, I just want to light and give you a sum up.

Driver and patients and these patients do very poorly Austin with chemo.

And this was this.

Combination.

Precisely.

Targeting the two drivers Egfr mutation.

Speaker #7: So in the first half of 2025, we completed SHPL partial divestment. With the preceding of over 600 million US dollars. We also worked on two major products, salvaging it and frequenting it.

And put vacation.

Demonstrated.

Very strong clinical benefits.

And also a chemo free.

Weiguo Su: This combination, by precisely targeting the 2 drivers, EGFR mutation and MET amplification, demonstrated very strong clinical benefits, and also chemo-free. Additional trials are ongoing, including the first-line EGFR mutant non-small cell lung cancer with MET overexpression in China called the SANOVO study, as well as the global phase III study in second-line EGFR mutant non-small cell lung cancer called SAFFRON study. We look forward to data readout of these trials. We believe MET activation plays a major role in driving cancer growth and proliferation. In addition to lung cancer, as Michael pointed out, we also anticipate NDA submission for savolitinib in China in gastric cancer. We also expect data to read out in the global pRCC study, in combination with durvalumab.

And additional trials are ongoing including the first line.

<unk> mutant non small cell lung cancer with met over expression.

Speaker #7: In an effort to expand their indications. Salvaging it, obtained the Saatchi approval in second line EGFR mutant non-small cell lung cancer with med amplification.

In China quota.

Nova study.

Speaker #7: we We anticipate following the treatment with third generation EGFR TKI about one third of patients will develop resistance due to med amplification. So this combination, the approval of this combination, salvaging it plus osimertinib, offers a a treatment potential for these patients and med amplification as we know is a driver and patients and these patients do very poorly on standard chemo.

As well as the global.

Phase III study in second line Egfr mutant mutant non small cell lung cancer Sepharose study. So we look forward to.

Data read out of these trials.

We believe Matt.

No.

Activation.

Play plays a major role in driving cancer growth.

Proliferation.

In addition to lung cancer as Mike pointed out we also anticipated NDA submission for <unk> in China in gastric cancer.

And we also.

Expect the data to read out in the global.

<unk> study.

In <unk>.

Speaker #7: And this combination by precisely targeting the two drivers, EGFR mutation and med amplification, demonstrated very strong clinical benefits and also chemo free. And additional trials are ongoing including the first line EGFR mutant non-small cell lung cancer with med overexpression in China called Sanova study.

Combination with things.

Frequently.

We obtained approval in second line.

Endometrial cancer early this year and we are filed.

For RCC. So these additional indications.

Continuing to drive.

The commercial performance of Quintanar being China.

Weiguo Su: For fruquintinib, we obtained approval in second-line endometrial cancer early this year, and we filed for RCC, these additional indications will continue to drive the commercial performance of fruquintinib in China. Outside China, FRUZAQLA continues to grow, deliver 25% growth in the H1, and we expect launches of this innovative product in other countries around the world in coming months. These launches will continue to drive the growth of FRUZAQLA outside China. Midterm, strategically, we are exploring how we can leverage our cash to accelerate growth, both in commercialization and potentially R&D portfolio as well. Looking for opportunities to acquire commercial products or pipeline candidates. Of course, we are highly focused on our ATTC platforms, very innovative, globally first-in-class molecules. Really, I look forward to the first molecule initiating clinical trial later this year, and with more to follow.

Outside China for exactly continues to grow deliver 25% of growth in the first half.

And.

We expect a.

Speaker #7: As well as the global phase three study in second line EGFR mutant non-small cell lung cancer called saffron study. So we look forward to data readout of these trials we believe met activation play plays a major role in driving cancer growth and proliferation.

Launches of this innovative product.

Product and other countries.

Around the world.

In coming months so.

Our launches.

This launches will.

Continue to drive the growth for sarcoma, mostly China.

Yeah.

So mid term.

Strategically we are exploring.

Speaker #7: In addition to lung cancer as Mike pointed out, we also anticipate NDA submission for salvaging it in China in gastric cancer. And we also expect the data to read out in the global PRCC study in a combination with the INFINSI.

How we can leverage our cash too.

The accelerated growth.

Both in <unk>.

Commercialization and a potentially R&D portfolio as well, so looking for opportunities to acquire products or <unk>.

Commercial products or pipeline.

Candidates.

Speaker #7: Frequenting it we obtained approval in second line endometrial cancer early this year and we RCC so filed for these additional indications will continue drive the commercial performance of frequenting it in China.

Of course, we are highly focused at&t's platforms.

Platforms very.

Innovative.

Globally first in class molecules.

Really look forward to the first molecule initiating clinical trial.

Later, this year and with more to follow.

Longer term.

Speaker #7: Outside China for exactly continues to grow. Deliver 25% growth in the first half and you know we expect launches of this innovative product in other countries around the world.

Need to if <unk>.

<unk> reach.

Clinical proof of concept is demonstrated in.

Preclinical setting.

Expect this entity sees too.

Two.

Positioning us for the long term future growth.

Speaker #7: In coming months so there are launches you ow these launches will continue to drive the growth of for exactly outside China. So midterm strategically we all exploring how we can leverage our cash to accelerate growth both in commercialization and potentially R&D portfolio as well.

Weiguo Su: Longer term, if ATTCs reach clinical proof of concept as demonstrated in preclinical setting, we expect these ATTCs to position us for the long-term future growth. These programs will, as you know, have potential to be positioned in earlier lines, particularly front lines, in combination with chemos, in combination with IOs, and in combination with targeted therapies. We expect that these platforms will deliver multiple products in the future for us. Next slide. I think you've seen this before. We remain on course. We are committed to profitability, and we look to the future with our next wave of innovation. Thank you very much. I think we are now open for questions. David, you on?

These programs will.

As you know right, we'll have potentially two.

To be positioned.

Early aligns, particularly frontline in combination with <unk>.

Kilos in combination with <unk> in combination with targeted therapies. So we expect that.

These platforms will deliver multiple multiple products in the future for us.

Next slide let's think of this.

Speaker #7: So looking for opportunities to acquire products or commercial products or pipeline candidates. And of course we are highly focused on our ATTC platforms very innovative globally first in class molecules really I look forward to the first molecule initiating clinical trial later this year and with more to follow.

You've seen this before we remain on course, we are committed to profitability.

And we look to.

To the future.

With the next wave of innovation.

Thank you and thank you very much I think we are now open for.

Questions David.

Thank you Dr. Sue So we're now open for questions. So just staying for the instructions are if you have a question you can press the raise hand button at the bottom of your screen.

Speaker #7: Longer term we need to if ATTCs reach clinical proof of concept as demonstrated in preclinical setting we expect these ATTCs to position us for the long-term future growth.

Or you can type your question in the chat box and I will.

Ask the question on your behalf. So for the first question can we have I'm Matthew Gan from asset Ixia RSA. Matthew Your line is now at <unk> go ahead.

David Ng: Yep. Thank you, Dr. Su. We are now open for questions. Just for the instructions, if you have a question, you can press the raise hand button at the bottom of your screen, or you can type your question in the chat box and I will ask the question on your behalf. For the first question, can we have Matthew Yan from CITIC Securities? Matthew, your line is now unmuted. Go ahead.

Speaker #7: These programs will you ow as you know right will have potential to to be positioned in early alliance particularly front lines in combination with chemos in combination with IOs and in combination with targeted therapies.

Okay.

Thanks, David and that is true for taking my questions.

Yes, I've got three questions. The first is regarding our exciting ADC platform.

Rhonda.

Is it is it am I right that that would be able to we're likely to see what's drug targets. It is in second half this year.

Speaker #7: So we expect that these platforms will deliver multiple multiple products. In future for us. Next slide. I think it this we you've seen this before.

Matthew Yan: Okay. Thanks, David and Dr. Su for taking my questions. Yeah, I've got three questions. First is regarding our very exciting ATTC platform. I wonder, am I right that we will likely to see what drug targets it is in H2 this year? Firstly, regarding A251 and also the development strategy. It seems that, am I right that you go directly to the front line as combo chemo standard of care, right? This is first question regarding ATTC. Second is still about the performance and the sales decline. I think you mentioned in your report that there's some reason related to the transitional impacts of the change of sales team and marketing strategy. Can you get more elaboration on this? This is my second question.

Regarding April one.

And also the development strategy. It seems that am I right that you will go directly to the frontline.

Speaker #7: We remain on course we are committed to profitability and we look to you know to the future you know with our next wave of innovation.

Combo chemo standoff cure right. So this is the first discretion regarding ATC.

Second is the about what to do about it.

Farmland has done so.

<unk> decline.

Because the thing you mentioned in your annual.

Speaker #7: Thank you and thank you very much. I ink we are now open for questions. David, you want.

Report that there's some reason related to the transitional it backs up to change our sales team and marketing strategy.

Speaker #8: Yep, thank you Dr. Su. So we are now open for questions. So just in for the instructions if you have a question you can press the raise hand button at the bottom of your screen.

Can you get more elaboration on this and.

And just my second question. So a question and answer regarding the thick behavior suffered panic.

Speaker #8: Or you can type your question in the chat box and I will ask the estion on your behalf. So for the first question can we have Matthew Yan from City CLSA Matthew your line is now unmuted go head.

Because of my original expectation you start to have finished the <unk>.

Tasked by end of this year and received Anda approvals. So whats the new message from city regarding this new change of Ah Ah.

Matthew Yan: Third question is regarding the SYK inhibitor, sovleplenib, because of my original expectation is that to have finished the instability test by end of this year and receive NDA approval. What's the new message from CDE regarding this new change of a new submission required next year? Yeah. That's all. Thank you.

Based on the required next year, yes.

Speaker #9: Okay, thanks David and Dr. Su for taking my questions. Yeah, I got three questions. First is regarding our very exciting ADTC platform. I wonder is it is it am I right that we will likely to see what drug targets it is in second half this year?

That's all thank you.

Okay.

Thank you very much Matthew for your question.

I briefly touch on.

Questions and maybe Mike can Germany later.

Regarding AT&T targets.

Ill.

The plan is to.

For 2020.

Speaker #9: Firstly regarding A251. And also the development strategy it seems that am I right that you will go directly to the front line combo chemo standard of care right?

A 251, which IND submission.

Weiguo Su: Okay. Thank you very much, Matthew, for your questions. I'll briefly touch on your questions, and maybe Mike can chime in later. Regarding ATTC targets, the plan is for A251, which IND submission expected in early September, just about 1 month from now. Our plan is to disclose the structure, both the antibody and the payload, at the upcoming EORTC conference. You will have all the information, all the preclinical development, all preclinical data at EORTC. Development strategy, clearly, I think these molecules are very different from chemos. They'll have a very different from chemo or toxin-based ADCs. They will have very different safety profile. We expect that these molecules will be able to be combined with a variety of therapies, as I mentioned, including chemo, SOC, or IO, or even other targeted therapies.

Submission expected in September.

Early September.

Just about a month from now.

We expect to our plan is to too.

Speaker #9: So this is first question regarding ATTC. And second is about still about the the performance and the sales decline. Because I think you mentioned in your and your in your in your report that there's some reason related to the transitional effects of the change of the sales team and marketing strategy.

Disclose the structure, both the antibody and the payload.

The upcoming <unk> conference.

So you will see.

It will have all the information all the preclinical.

Development.

Or clinical preclinical data at <unk>.

Speaker #9: Can you get more elaboration on this? And this is my second question. Third question is regarding the sick inhibitor software planet. Because of my original expectation is that to have finished the instability test by the end of this year and received NDA approval.

Yeah.

Yes, given the strategy clearly.

I think they have these molecules are very different from kilos.

They'll have.

So very different from <unk>.

<unk> or <unk> based adcs that will have very different safety profile.

Speaker #9: So what's the new message from CDE regarding this new new change of a new submission required next year? Yeah. That's all, thank ou.

And we expect that this model because it can be will be able to to be combined with <unk>.

A variety of therapies as I mentioned, including.

Speaker #10: Okay, thank you very much Matthew for your questions. I briefly touch on your questions and maybe Mike can chime in later. So regarding ATTC targets, I'll the plan is to for A251 which IND submission expected that in September.

No chemo, SLC, Ohio, or even other targeted therapies. So.

The development strategy for this molecule, we will obviously look for signals in the in the <unk>.

Early development.

Certainly they have.

Potential too.

Target.

Speaker #10: Early September. Just about a month from now. We expect to our plan is to disclose the structure both the antibody and the payload at the upcoming EORTC conference.

Tumors with.

With.

Weiguo Su: The development strategy for these molecules will obviously look for signals in the early development. Certainly, they have potential to target tumors with either the genetic aberration or genetic alteration, which our payload targets or high overexpressing and so forth, so as a monotherapy. However, that might be a strategy for rapid biomarker-selected pathway for registration. The much greater potential is in combination in first line, in combination with chemo IO, or even other targeted therapies, targeting all comers without even genetic alterations. We will explain the rationale at the EORTC conference. That's about ATTC sales decline. Team transitioning certainly has some impact. A lot more than that, as you know, the anti-corruption activity has been going on in China for some time. Compliance is now becoming more and more important. Physicians are fully aware of compliance issues.

Either the genetic.

<unk> or genetic.

Alteration.

Uh huh.

Which all of payload targets or.

Uh huh.

Speaker #10: So you will see you will have all the information all the preclinical development all clinical preclinical data at EORTC. Yeah, development strategy clearly I think they have these molecules are very different from chemos.

Hi over expression and so forth so as a monotherapy.

However.

But that might be a strategy for rebate.

Biomarkers selected.

Pathway for for registration, but.

Much greater potential in combination in first line.

Speaker #10: They'll have a very different from chemo or toxin-based ADCs. They will have very different safety profile. And we expect that these molecules can be will be able be combined with a variety of therapies as I mentioned including you know chemo SOC or IO or even other targeted therapies.

In combination with chemo chemo Io or even.

Of the targeted therapies.

Uh huh.

Targeting all comers without even.

Genetic alterations.

We will explain the rationale.

And the RPC call for us.

So that's about a TTC sales decline team.

Speaker #10: So the development strategy for these molecules will obviously look for signals in the in the early development. Certainly they have potential to target tumors with either the genetic aberration or genetic alteration which our payload targets or you ow high overexpression and so forth.

<unk> certainly had some impact.

But a lot.

More than that as you know the anticorruption trial.

Crossing.

The crushing activity has been going on in China for some time.

So compliance.

Is now becoming more and more.

Important physicians.

Fully aware of compliance issues so they.

So there is a.

Our practice changing.

In the field or in hospitals.

So there is certainly much less well much care much more careful off label.

Speaker #10: So as a monotherapy however, we all but that might be a strategy for rapid biomarker selected pathway for for registration. But the much greater potential is in combination in first line in combination with the chemo IO or even other targeted therapies.

Usage.

Prescribed by the doctors.

Weiguo Su: There is a practice change in the field or in hospitals. There is certainly much more careful off-label usage prescribed by the doctors. That certainly will shrink the off-label contribution to the total sales. Team is in transition. I think now we are over with it. The off-label usage dropped but now stabilized. As a matter of fact, Q1 bottomed out, and Q2 start to grow. We are pretty much back to where we would expect in June and July. We are very optimistic the H2, the momentum will continue, and will perform to our expectations. We believe the sales decline in China is transitory, and we are already seeing the recovery, and we are quite optimistic about H2. Your last question about SIC.

And.

So that.

Certainly will.

Shrink of the off label contribution.

The total sales.

So team is in transition I think now we.

We are over with it.

The off label usage.

Speaker #10: Targeting all comers without even genetic alterations. And we will explain the rationale. At the EORTC conference. So that's about ATTC. Sales decline team transition certainly has some impact.

Dropped about now stabilized.

As a matter of fact.

First quarter was bottom now in the second quarter start to grow.

We are pretty much back to where we are we.

I would expect.

In June and July so we are very optimistic in the second half.

Speaker #10: But a lot more than that as you know the anti-corruption trial anti-corruption anti-corruption activity has been going on in China for some time. So compliance is now becoming more and more important physicians are fully aware of compliance issues.

The momentum will continue and we will.

<unk> performed to our expectations so.

We believe the sales decline in China as is.

As transitory and we are already seeing the recovery and we are quite optimistic about about second half.

Speaker #10: So they so you know there is a a practice change in in in the field or in hospitals so there is certainly much less or much care much more careful off-label usage.

The last question about sick.

So.

<unk>.

It went through a lot of discussion we went through a lot of discussions with the city on on there.

Speaker #10: You know prescribed by the doctors. And and so that you ow certainly will shrink the off-label contribution. To the total sales. So team is in transition I think now we we are over with it.

This particular impurity in how we address it both in terms of using Tox studies to quantify the the level and.

Weiguo Su: We went through a lot of discussions with CDE on this particular impurity and how we address it, both in terms of using tox studies to quantify the level and additional CMC studies to bring it all the way down to a minimum or to below the target or allow the target level. The activities went on in these two areas in parallel, and recent communication with CDE, they guided us to focus on CMC, and now we are full speed ahead in a CMC area where we have to complete the PPQ batches, accumulate the stability data, but we expect to have the data available for initial submission March or April 2025, and with additional or longer-term stability data to be rolled in since the program is under breakthrough therapy designation in China. That's where things are.

Additional CMC studies to bring it all the way down.

To a minimum.

Below the target will allow the target.

Speaker #10: The off-label usage dropped but now stabilized. As a matter of act first quarter was bottomed out and and the second quarter start to grow.

Targeted level so.

Activities in these two areas in parallel and recent communication with Citi.

They.

Guided us to focus on CMC.

Speaker #10: We are pretty much back to where we we we would expect in in in June and July so we we are very optimistic the second half the momentum will continue and and will perform to our expectations.

And now we are.

<unk> be the head.

In.

In the.

<unk>.

In our CMC area, we have where we have to.

Completed 52 batches accumulated assist stability data.

But we expect to.

Speaker #10: So we believe the the sales decline in China is is is is transitory and and we are already seeing the recovery and and we are quite optimistic about about second half.

Have.

The data available for initial submission.

March or April next year.

And with additional longer term stability data to be rolled in.

So the program is on the breakthrough therapy designation in China. So that's that's where things are.

Speaker #10: Your last question about sick. So it's it went through a lot of discussion we went through a lot of discussions with CDE on on this particular impurity and and how we address it both in in terms of using talk studies to qualify the the the level and additional CMC studies to bring it all the way down to a minimum.

We're all disappointed in the delay.

No we have clarity we are we.

Can drive with it.

All our activities.

I also want to mention it.

About.

Potential out licensing outside China.

This program as you know because of these issues we pretty much.

Weiguo Su: I know we're all disappointed of the delay, but at least now we have clarity. We can drive with it, with all our activities. I also want to mention about potential out-licensing outside China. This program, as you know, because of these issues, we pretty much stopped the outside China clinical development, even though US FDA was okay with the level of the impurity, allowed us to proceed, but we felt we wanted to explore ways to sort this out. I think the issues in China forced us to look into other ways. I think we potentially have a strategy to go forward with in the US with a new chemical entity with full patent life. I think it would make a lot of sense to switch the molecule outside China completely and with a much longer LOE for the product.

<unk>.

Stopped.

Speaker #10: Or to blow the the the target or allow the target target level. So you know the activities went on in these two areas in parallel and recent communication with CDE they guided us to focus on CMC and and now we are full speed ahead in in in in the in the CMC area we have where we have to complete a PPQ batches accumulated stability data but we expect to have the data available for initial submission March or April next year and with additional or longer term stability data to be rolled in since the program is under breakthrough therapy designation in China.

Outside China clinical.

Development.

Even though U S. FDA was okay with where the level of the.

Of the impurity.

Allowed us to proceed but but we felt.

We wanted to.

Explore ways to sort this out.

And.

Think of this force the issues in China forced us to looking to other ways. So I think we are we potentially have a strategy to go forward with in the U S with a new chemical entity.

With the with full.

Patent life, So I think it would make a lot of sense too.

Hum.

Switch the molecules like China completely in.

With a much longer.

Hello.

For the product.

Speaker #10: So that's that's where things are I know it's you ow we are all disappointed of the delay but at least now we have clarity we we are we can drive with with you know our our activities.

But potentially it could be a very short development timeline because of the unknown target.

Uh huh.

And.

So I think any outside China actually presents a very attractive our licensing opportunity.

Speaker #10: I also want mention about potential outliers outside China. This program as you know because these issues we pretty much stopped the outside China clinical development.

Finish.

Subclinical.

Weiguo Su: Potentially it could be a very short development timeline because of the known target. I think outside China, it could actually present a very attractive out-licensing opportunity once we finish some early clinical development. At least now we think it's a great target for these indications. It's probably the best in ITP and WAIHA we have done so far, and it could be potentially useful for other indications as well. I think with regard to ATTC and SYK, maybe Mike, if you have anything to chime in.

Of early clinical.

Development.

No.

It's a great target for these indications that it's probably the best in <unk> NOI, how we have done so far and it could be potentially.

Speaker #10: Even though US FDA was okay with with the level of the of the impurity allowed us to proceed but but we felt you know we wanted explore ways to sort this out.

Useful for other indications as well so think of this.

With regard to ATC in sick and maybe Mike if you have in essence to chime in.

Yeah.

So thanks, Dr. Sue I just mentioned.

Speaker #10: And and I think this forced the issues in China forced us to look into other ways. So I think we are we potentially have a strategy to go forward with in the US with a new chemical entity with a with a full patent life so so I think it would make a lot of sense to to switch the barricade outside China completely and and with a much longer LOE for the product.

You mentioned that part that clinical the polymer side I think we are very excited about this 251 development and what we're trying to do is really.

Global Dybala must simultaneously with the U S China development, because really not only leverage.

Hours.

Energy, but also take advantage some of the regulatory.

Michael Shi: Yeah. Thanks, Dr. Su. I just want to mention for the clinical development side, I think we're very excited about this 251 development. What we're trying to do is really the global development simultaneously with the US, China development, because really not only leverage our synergy, but also take advantage some of the regulatory approach, particularly in the United States. The FDA is really kind of encouraged through this project front runner, right? You can actually start the combination in earlier line setting much sooner compared with actually the CDE. I think this is a part of the development strategy we're going to undertake. Even when we have the dose escalation, define the dose, we could actually move to the front line combination earlier. That will be the key for our development strategy.

Approach, particularly in the United States the FDA is really.

Kind of.

Encourage fought.

This project front runner right.

You can actually start the combination the earlier line setting much sooner comparable isolate the C. D. So I think this is a part of the.

Speaker #10: But potentially it could be a very short development timeline because of the known target known and and so think getting outside China it could actually present a very attractive out-licensing opportunity once we finish some clinical early clinical development.

Development strategy.

Undertake.

Yeah.

Even when.

When we have that dose escalation defined a dose we could actually move to the frontline combination.

Earlier, so that will be the key for our development strategy.

Speaker #10: At least now with we think it's a great target for for these indications it's probably the best in ITP and Wiha we have done so far and it could be potentially useful for other indications as well.

And we think also right you talk about its target.

We are planning to close that.

Future Scientific conference.

Later this year.

Speaker #10: So I I think this with regard to ATTC and sick maybe Mike if you have anything to chime in.

But I think the most important like I mentioned.

Our antibodies part selection DSA.

Michael Shi: We think also, right, you talk about its target, and we are planning to disclose at a future scientific conference later this year. I think the most important, like I mentioned, our antibodies part selection is a well-known target and have a well-established drug in the clinic. The payload is really the innovation part, and we think our target therapy payload with the linker will be developed, really leverage our in-house small molecule expertise, can really deliver a lot of potential first-in-class molecule. If it is a clinical proof of concept is reached, this will be a very robust platform for a lot of new generation molecules to come. Yeah. I don't think I have too much to add on the SYK inhibitor. Yeah. Thank you.

It's well known targets and have.

Speaker #9: Yeah, so thanks Dr. Su. I just want mention for the clinical development side I think very very excited about this 251 development and what we're trying to do is really the global development simultaneously with the US China development because really not only leverage our synergy but also take advantage of some the regulatory approach particularly in the United States the FDA is really kind encouraged for through this project front runner right.

Well established the drug in the clinic.

The payload is really the innovation part and we think our targets at RP payload with Sterne.

Linked car will be developed we really leverage our in house small molecule expertise can really.

Deliver a lot of potential first in class molecule.

If this.

If it is the clinical proof of concept has reached this won't be a very.

Robust platform for a lot of new generation molecule to come yeah. So I don't think I have too much to add on the sick part.

Speaker #9: You can actually start a combination early line setting much sooner compared with actually the CDE. So I think this is a part of the development strategy we're going to undertake you know even when we you ow have the those escalation defined those we could actually move to the front line combination earlier.

S Y K inhibitor, yeah. So thank you.

Thanks Scott.

Okay. So our next question is from Chen Chen of UBS.

Your line is now open you can go ahead.

Speaker #9: So that will be the key for our development strategy. We think, right, you talk about a target, and we are planning to close at a future scientific conference later this year.

Okay.

Pension.

You can now go ahead.

David Ng: Thank you, Michael Shi. Thank you, Dr Su. Next question is from Chen Chen of UBS. Chen Chen, your line is now open. You can go ahead. Chen Chen, you can now go ahead. We can't hear. Maybe we'll come back to Chen Chen. Let's take the next question first. Paul Choi of Goldman Sachs, let us unmute your line now. Paul, please go ahead.

We.

Speaker #9: But I think the most important like I mentioned our antibody part selection is a it's a well-known target and have a well-established drug in the clinic but a payload is really the innovation part and we think our targets therapy payload with the linker will be developed really leverage our in-house small molecule expertise can really deliver a lot of potential first in class molecule you know if this if it is a clinical proof of concept it reached this will be a very robust platform for a lot of new generation molecule to come yeah.

Can hear maybe it will.

Maybe I'll come back to Shenzhen.

Let's take the next question first.

Paul Choi of Goldman Sachs.

Let us unveil your line now and Bob Pease go ahead.

Hi can you hear me now yes, okay.

Good evening and thank you for taking our questions and congratulations on the progress.

I want to maybe just address the commercial side a bit first.

Dr. Sue you talked about your confidence in the second half recovery.

But I want to maybe just asking how youre thinking about potential economic sensitivity here.

Paul Choi: Hi, can you hear me now?

David Ng: Yes.

Paul Choi: Okay. Hi, good evening, and thank you for taking our questions, and congratulations on the progress. I want to maybe just address the commercial side a bit first. Dr. Su, you talked about your confidence in the H2 recovery. I want to maybe just ask how you're thinking about potential economic sensitivity here on affecting end demand for oncology products in the China market, and just sort of what your thoughts are on sensitivity to the broader economic situation. Following up on your comments on the SYK inhibitor and partnering potentially for a next generation or follow-on molecule here. Can you maybe just comment on what your timing you think could be for initial entry into the clinic there? I know that's contingent upon a partner, but just sort of what potential timeframe you're thinking about there. That would be helpful. Thank you very much.

Affecting end demand.

And your for oncology products in the China market and just sort of what your thoughts are on sensitivity to the economics broader economic situate them.

Speaker #9: So I don't think I have too much to add on the sick part the SYK inhibitor yeah. So thank ou.

Speaker #8: Thank you Dr. Shi thank you Dr. Su next question is from Chen Chen of UBS. Chen Chen both of your line is now open you can go head.

And then.

Following up on your comments on the second habit or and in partnering.

Potentially for next generation of our follow on molecule here.

Can you maybe just comment on how what your timing you think could be for NFL and frame into the clinic. There I know that's contingent upon a partner, but just sort of what.

Speaker #8: Chen Chen. You can now go head. We can't hear maybe we'll maybe we'll back to Chen Chen let's take the next question first. Paul Choi of Goldman Sachs let us unmute your line now and Paul please go head.

Potential timeframe youre thinking about there that would be helpful. Thank you very much.

Okay.

Alright, Thank you Paul.

On the commercial.

China commercial as you know, it's been a bit turbulence because of the anti corruption and compliance requirements and also for Hudson, adding particular.

Obviously the team.

Weiguo Su: All right. Thank you, Paul. On the China commercial, as you know, it's been a bit turbulent because of the anti-corruption and compliance requirements and also for HUTCHMED in particular. Obviously the commercial team has gone through a lot of changes as well. Overall, I think the market remains there. Competition may be up, as George pointed out, particularly in CRC. If anything, actually the own label CRC, we actually saw growth over H1 of last year for fruquintinib as well as for surufatinib in neuroendocrine tumors. I think George's team now sorted out the marketing strategy, and it seems it's working, and I think the team needs to adapt to the marketing driven strategy and help physicians understand our products and also to help patients, obviously.

Speaker #10: Hi, can you hear me now?

The hold co.

Speaker #8: Yes.

Speaker #10: Okay, hi good ing and thank you for taking our questions and congratulations on the progress. I want to maybe just address the commercial side a bit first and Dr. Su you talked about your confidence in the second half recovery but I want to maybe just ask you know how you know you're thinking about potential economic sensitivity here.

<unk> team has gone through a lot of changes as well.

Overall, I think the market remains there.

Competition may be up as George pointed out, particularly in CRC.

But.

If anything actually the own label CRC, we actually saw growth over last year first half of last year.

Speaker #10: Affecting end demand in your for oncology products and in China market and just sort of what your thoughts are on sensitivity to the economic broader economic situation.

For <unk>.

Well as well.

So refer to nib in neuroendocrine tumors.

Speaker #10: And then following up on your comments on the the sick inhibitor and and partnering you know potentially for for a next generation or follow-on molecule here.

So I think that what we need to.

I think George has teams now.

Sorted out the marketing strategy.

It's working in.

Speaker #10: Can you maybe just comment on you know how what your timing you think could be for initial entry into the clinic there. I know that's contingent upon a ner but just sort of what you know potential timeframe you're inking about there that would be helpful.

I think when you just do too.

Take two.

[noise] adapt the team needs to adapt to the.

Marketing driven.

Uh huh.

Strategy in health.

Speaker #10: Thank you very much. All right, thank you Paul. On the commercial China commercial as you know it's being a bit turbulent because of the anti-corruption and compliance requirements.

Help.

Physicians understand the oil products and also.

To help patients so obviously.

Think.

Obviously expressed.

Hope to see them for the for the second half.

Speaker #10: And also for Hutch Matting particular obviously the team the whole the commercial team is going through a lot of changes as well. Overall I think the market remains there competition may be up as George pointed out particularly in CRC but if anything actually the on-label CRC we actually saw growth over the last year.

Linda.

<unk> built on the.

Strong performance a strong recovery.

Of these products in China.

In the last in the past three months.

Weiguo Su: I obviously expressed optimism for H2, and that's built on the strong performance or strong recovery of these products in China in the past 3 months. It's been challenging. We just want to be transparent. We are seeing good momentum at the moment, and I believe that the momentum will continue in H2. The demand obviously is there. On the SYK, yeah, this is going to be a very interesting approach. I hope we can talk more about it. It will be very rapid. We expect the new entity will be in clinic or IND submission maybe Q2 next year. Hopefully in the clinic before end of Q2. Most important is that we believe this is going to be a very rapid clinical development. Mike sometime will be able to share with all of you.

Uh huh.

It's being challenging.

You just wanted to be transparent.

But we are seeing.

Good momentum at the moment.

I believe that the moment that the momentum will continue.

Speaker #10: First half of last year. For frequenting it as well as for surfactant in new endocrine tumors. So I think that what we need I think George's team's now sorted out the marketing strategy and it seems it's working and I think we just need to take you know to adapt the team needs to adapt to the to the marketing driven strategy and help physicians understand our products and also to help patients so obviously.

Yeah.

In the second half the demand obviously is there.

On a sick.

Yes, this is going to be.

A very interesting approach.

I hope, we can talk more about it will be very rapid.

We expect.

The new entity will do.

In clinic or R&D for submission.

Maybe second quarter next year.

So.

Oh.

Hopefully in the clinic before.

End of second quarter.

And and.

Most important.

Is that this is going to be.

Speaker #10: I ink I obviously expressed opticism for the for the second half and that's built on the strong performance or you know strong recovery of these products.

We believe it's going to be a very.

The clinical development Mike.

Yeah.

All of it.

And.

Clearly with the.

Speaker #10: In China in the in the last in the past three months. So it's been challenging we you know we just want to be transparent but we are seeing good momentum at the moment and I I believe that the moment that the momentum will continue.

High probability of success because this is a.

This is in a non target and where you have a lot of data to support.

So the probability of success should be very high so I think by the time, we are ready to go to go into the clinic hopefully we.

Weiguo Su: Clearly with high probability of success, because this is a known target, and we have a lot of data to support. The probability of success should be very high. I think, yeah, by the time we are ready to go into clinic, hopefully we have a partner to either co-develop or license. Yeah.

Speaker #10: In the you ow in the second half the demand obviously is is there. On the sick yeah this is going to be a very interesting approach I think I hope we can talk more about it there be very rapid I we expect the new entity will be in clinic or IND submission maybe second quarter next year.

We have a partner too.

To either co develop or license.

Okay, great. Thank you. Thank you. Thank you Paul. Thank you Doctor. So we just have one last question because of time, we try a UBS change and one small time Tien Shen. Your line is now open. Please go ahead.

Thank you can't hear me now yes, yes. Thank you.

That's good so thanks management for taking my questions. My first question is on Paris.

Paul Choi: Okay, great. Thank you.

Weiguo Su: Thank you.

David Ng: Thank you, Paul. Thank you, Dr. Su. We just have one last question because of time. We'll try UBS, Chen Chen one small time. Chen Chen, your line is now open. Please go ahead.

And earlier this week trumps that that's pharma tower is going to be impulse, starting from more next week and then up to 250% ultimately so can management. Please comment on the impact of your frequently himself in the U S.

Speaker #10: So you know hopefully in the clinic before end of second quarter. And and most important is that this is going to be a we believe it's going to be a y rapid clinical development Mike sometime will be able to share with all of you.

Chen Chen: Thank you. Can you hear me now?

David Ng: Yes. Thank you.

Chen Chen: Oh, that's good. Thanks management for taking the questions. My first question is on tariff. Earlier this week, Trump said that pharma tariff is going to be imposed starting from small next week and then up to 250% ultimately. Can management please comment on the impact of your fruquintinib sales in the US? My second question is for your savolitinib, when can we expect its NDA submission in third line gastric cancer in China? Also for your EZH2, will you consider an NRDL negotiation or commercial insurance drug list this year? Thanks.

And my second question is for your cyber Nathan when can we expect NDA submission in third line gastric cancer in China and also for your ease acts too well.

Speaker #10: And you know clearly with with with high probability of success because this is you know this is a known target and we have a lot of data to support.

Oh, well would you consider like a lot be a negotiation or commercial insurer restaurant this year.

Yeah.

Yeah.

Okay. Thank you for the questions.

Speaker #10: So the probability of success should be very high. So I think yeah by the time we ready go to clinic go into clinic hopefully we you know we have a partner to to either co-develop or all license yeah.

Tariffs to be honest, we don't have any idea about but given.

No.

The exporting.

Or the manufacturing cost cost of.

For the <unk> is relatively low.

Speaker #8: Okay, great thank you.

Weiguo Su: Okay. Thank you for the questions. Tariffs, to be honest, we don't have any idea. Given the exporting or the manufacturing cost for the fruquintinib is relatively low. To be honest, I don't have any idea about the impact. I'm sure it's going to be higher. They have to pay the tariffs. Personally, I think the impact won't be that much. Until we actually understand the details, I think it's very difficult to estimate. Your second question on GC for savolitinib. NDA filing is planned later this year, likely end of this year. This is for late stage gastric cancer with MET amplification. EZH2 product, TAZVERIK, of course, we are preparing for an NRDL discussion later this year. Obviously this is a very different product. At the moment, it's still imported drug.

So to be honest I don't I don't I don't.

Speaker #10: Thank ou.

Speaker #8: Thank you Paul thank you Dr. Su we just have one last question because time. We'll try UBS Chen Chen one small time Chen Chen your line is now open please go ahead.

Have any idea about the impact I'm sure it's going to be higher.

Have to pay something to pay that to have to pay the tariffs, but I think that.

Speaker #11: Thank you can ou hear me now.

Hey.

Speaker #8: Yes, yes thank you.

Personally I think of the impact won't be won't be that much.

Speaker #11: Oh, that's good. So thanks to management for taking my questions. My first question is on tariffs. And earlier this week Trump said that pharma tariff is going to be imposed starting from small next week and then up to 200 and 50% ultimately.

But until we actually understand the details there I think is very difficult to.

Uh huh.

To estimate.

Your second question on G C.

All four serve alliterative.

Speaker #11: So can management please comment on the impact of your frequently sales in the US. And my second question is for your salvaging it when can we expect its NDA submission in third line gastric cancer in China.

NDA filing is planned later this year likely end of this year.

This is for sure.

For a late stage gastric cancer with met amplification.

Speaker #11: And also for your easy H2 well will you consider like an RDL negotiation or commercial insurance jargonist this year. Thanks.

Is age to product as it does work of course, we are preparing for and audio.

Discussion later this year and.

Speaker #10: Okay, thank ou for the questions. Tariffs to be honest we don't have any idea but but given you ow the exporting all the manufacturing cost cost of for the frequenting it is is relatively low.

Hum.

Yeah.

Obviously this is a very different product.

At the moment is imported.

<unk> of course is higher.

Hum.

The patient population is serves.

The first indication where you got approved for third line Follicular cancer, the Follicular lymphoma, which is a.

Speaker #10: So to be honest I don't I don't I don't have any idea about the impact I'm sure it's ing to be higher. They have to pay something to pay the they have to pay the tariffs but I think it the the the personally I think the impact won't be won't that much.

Relatively rare.

Full of.

Lymphoma so.

So overall I think we have lot to to talk about.

Weiguo Su: The cost is higher, and the patient population it serves, the first indication we got approved for is third line follicular cancer. A Follicular Lymphoma, which is a relatively rare form of lymphoma. Overall, I think we have a lot to talk about when we engage with the NRDO. Yeah, that's our plan at the moment. Thank you.

Well, we'd go up to the.

We engaged with and audio.

But yes.

That's our plan at the moment.

Thank you that's very clear thank you.

Thank you Tien tsin. Thank you Dr. Chris Xu I'm, sorry, we ran over a little bit, but and I noticed there may be some questions still outstanding, but so do feel free to reach out.

To us and we will try to answer your question is maybe offline so.

So thank you everyone for supporting us and listening to the call and thank you Doctor Sue Tucker.

Chen Chen: That's very clear. Thank you.

She Juliet charge for attending the call.

David Ng: Thank you, Chenchen. Thank you, Dr. Su. Sorry we ran over time a little bit. I noticed there may be some questions still outstanding. Do feel free to reach out to us and we will try to answer your questions maybe offline. Thank you everyone for supporting us and listening to the call. Thank you, Dr. Su, Dr. Shi, Johnny, and George for attending the call. That's all for the call. Thank you.

And that's all for the call. Thank you.

Thank you.

Thank you all.

[Company Representative] (HUTCHMED): Thank you.

Weiguo Su: Thank you all.