Q2 2026 HUTCHMED (China) Ltd Earnings Call

July 30, 2026

Speaker #2: You have joined the meeting as an attendee and will be muted throughout the meeting.

Speaker #3: Welcome, everyone. Thank you for joining HUTCHMED 2026 interim results announcement and presentation. Before we start, I will just like to go over the safe harbors statement and disclaimer on page 2.

Operator: Welcome, everyone. Thank you for joining HUTCHMED's 2026 Interim Results Announcement and Presentation. Before we start, I would just like to go over the Safe Harbor statement and disclaimer on page two. The performance and results of operation of HUTCHMED Group contained within this presentation are historical in nature. Past performance is no guarantee of future results. I would like to invite our Acting CEO and CFO, Johnny Cheng, to start the opening. Johnny?

Speaker #3: The performance and results of operations of HUTCHMED Group contained within this presentation are historical in nature, and past performance is no guarantee of future results.

Speaker #3: Next, I would like to invite our Acting CEO and CFO, Johnny Chen, to start the opening. Johnny?

Speaker #4: Okay, thank you, David. And welcome, everyone, again, joining our interim results webcast tonight. Together with me, we have our Deputy CFO, Lorenzo Gil, also George Yuan, Head of Commercial, and Dr. Dai, Head of Discovery and Global Portfolio Management. All of us will be sharing with you our first-half results and outlook.

Johnny Cheng: Okay. Thank you, David. Welcome everyone again, joining our interim results webcast tonight. Together with me, we have our Deputy CFO, Lorenso Chiu, also our George Yuan, Head of Commercial (China), and also our Dr. Dai, Head of Discovery and Global Portfolio Management. All of us will be sharing with you our H1 results and outlook. On page four, you can all see we have achieved a lot in the H1. China product sales have very strong results, especially ELUNATE and SULANDA, which grew by over 40%. FRUZAQLA global in-market sales were strong. Ex-US markets were up 70% after rapid geographic expansion. On the bottom left, we have received two approved label expansions, fruquintinib for RCC and savolitinib for GC. In addition, we have three NDAs in China under priority review. On the top right, our next wave of innovation focuses on ATTECs.

Speaker #4: So on page 4, you can all see we have achieved a lot in the first half. China product sales have very strong results. Especially LNH and Solenda, which grew by over 40%.

Speaker #4: For secular global in-market sales, we're strong. US markets were up 70% after rapid geographic expansion. On the bottom left, we have received two approved label expansions.

Speaker #4: For Quicknip for LCC and Subalternip for GC, in addition, we have three NDAs in China under priority review. On the top right, our next wave of innovation focuses on ATTCs.

Speaker #4: We have two first-in-class assets, which have entered phase one clinical trials. A third asset, HMPL 830, has cleared its IND and will be entering the clinic in the second half.

Johnny Cheng: We have two first-in-class assets which have entered the phase I clinical trials. A third asset, HMPL-A830, has cleared its IND and will be entering the clinic in the H2. At the same time, the global SAFFRON study and the China SANOVO study will have their data read out in the H2. I will now hand it over to Lorenso Chiu, our Deputy CFO, to discuss our financial results.

Speaker #4: At the same time, the global Saffron study and the China Sanofo study will have their data read out in the second half. I will now hand it over to Lorenzo Gil, our Deputy CFO, to discuss our financial results.

Speaker #3: Thank you, Johnny. On slide number 6, I'd like to give more details of our financials for the first half of 2026. First of all, our oncology revenue was 162 million.

Lorenso Chiu: Thank you, Johnny. On slide number six, I'd like to give more details of our financials with H1 2026. First of all, our oncology revenue was $162 million, including $121 million products revenue. This represents about 23% growth over H1 2025. Johnny already mentioned our China product sales have shown a very good performance in H1, but I'd like to highlight that ex-China, demand for FRUZAQLA continues to grow as well, achieving an overall 40% growth in in-market sales. With this H1 result, our full year guidance remains in the range of $340 million to $450 million. Altogether with other ventures revenues, the total group revenue amounted to $278 million. Next, please.

Lorenso Chiu: Thank you, Johnny. On slide number six, I'd like to give more details of our financials with H1 2026. First of all, our oncology revenue was $162 million, including $121 million products revenue. This represents about 23% growth over H1 2025. Johnny already mentioned our China product sales have shown a very good performance in H1, but I'd like to highlight that ex-China, demand for FRUZAQLA continues to grow as well, achieving an overall 40% growth in in-market sales. With this H1 result, our full year guidance remains in the range of $340 to 450 million. Altogether with other ventures revenues, the total group revenue amounted to $278 million. Next, please.

Speaker #3: Including 121 million products revenue. This represents about 23% growth over the first half of 2025. Johnny already mentioned our China product sales have shown a very good performance in the first half.

Speaker #3: But I'd like to highlight that ex-China, demand across the sector continues to grow as well. Achieving an over 40% growth in in-market sales. With this first half result, our full year guidance remains in the range of 330 million to 450 million.

Speaker #3: Altogether, with other advances revenued, the total group revenue amounted to 278 million. Next, please. On R&D expenses, which amounted to 79 million for the first half, compared to 72 million for the first half of 2025.

Lorenso Chiu: On R&D expenses, which amounted to $79 million for H1, compared to $17 million for H1 2025. The increase reflects on one thing, we initiate the global phase I trials of our ATTC assets, including HMPL-A251 and HMPL-A580. In addition, we increase our investments in our discovery capabilities, including our talents and AI. On the bottom line, we continue to be profitable with net income of $16 million. It is important to note in last year's, we have included a $416 million SHP divestment gain, and also the share of the post-divestments, about $21 million. With this strong operating results and cash growth, we continue to have a very good cash reserve of $1.4 billion. Now I'd like to hand over to Mr. George, our Head of Commercial, to give an update of our China commercial.

Speaker #3: The increase reflects on one thing. We initiate the global phase one trials of our ATTC assets, including 251 and 580. In addition, we increased our investments in our discovery capabilities, including our talent and AI.

Speaker #3: On the bottom line, we continue to be profitable with net income of 60 million. It is important to note in last years, we have included a 460 million SHPR divestment gain and also the share of the post-divestments, about 21 million.

Speaker #3: With this strong operating results and cash flows, we continue to have a very good cash reserve of 1.4 billion. Now, I'd like to hand it over to Mr. George, our Head of Commercials, to give an update of our China commercial.

Speaker #4: Thanks, Lorenzo. As Johnny mentioned, global expect geographic expansion continued to drive our for secular growth. If we look at the first half, we see a 70% growth in the geographic outside the US, which is very strong.

George Yuan: Thanks, Lorenzo. As Johnny mentioned, global geographic expansion continues to drive our FRUZAQLA growth. If we look at H1, we see 70% growth in the geographic outside the US, which is very strong. If you look at Q2, the growth rate actually accelerated to 27%. We still believe that there still is opportunity for more countries to get launched and also to go to reimbursement. Takeda already confirmed the fiscal year guidance of 25% growth. Next slide. If we look at China, we have very robust growth for ELUNATE in a highly competitive market. If we look at H1, we had growth at 41%, and the current NRDL review brings us continuous growth opportunity with the second line EMC included. We synchronize our MCRC reimbursement scope with our label.

Speaker #4: Q2, the growth rate actually accelerated to 27%. And also, we still believe there still has opportunity to get more country get launched and also going to the reimbursement.

Speaker #4: Takeda already confirmed the fiscal year guidance of 25% growth. Next slides. If we look at the China our we have a very robust growth for Eluned winning a very in a highly competitive market.

Speaker #4: If we look at the first half, we are gross at 41%. And the current NRDL renewal brings us continuous gross opportunity with the second line EMC included.

Speaker #4: And also, we synchronize our MCRC reimbursement scope with our label. The NRDL renew actually provide us a unique opportunity for future growth. And also, we keep our price flat.

George Yuan: The NRDL review actually provides us a unique opportunity for future growth. We keep our price flat. Second-line RCC got approval on 26 May, and this provides us another opportunity to apply for NRDL this year. Based on IQVIA Hospital Audit and our HU study, ELUNATE continues to be a market leader in third-line CRC. Next slide. Beyond FRUZAQLA and ELUNATE, we also have strong performance on ORPATHYS and SULANDA. ORPATHYS, we are targeting to include such indication in this year's NRDL review by end of this year. We got approval for third-line MAAM amplified GC. In the coming months, we are looking at SAFFRON and SANOVO readout. For SULANDA, we have strong growth in H1 based on the highly recommended by CSCO guideline for NET and the CSCO guideline changed the recommendation about SSA.

Speaker #4: Second-line RCC got approval on May 26. This also provides us another opportunity to apply for NRDL this year. Based on the IQVIA hospital audit and our ATU study, Eluned continues to be a market leader in solid mCRC.

Speaker #4: Next slides. Beyond for Secular and Eluned, we also have a strong performance of Passes and the Solenda. Our Passes, we are targeting to include such indication in this year’s NRDL.

Speaker #4: Renew by the end of this year. And also, we got approval for third-line MET-amplified GC. In the coming months, we are looking at Saffron and the Sanofi readout.

Speaker #4: For Solenda, we have seen strong growth in the first half. This is based on the highly recommended fiscal guideline for the net. Also, the fiscal guideline changed the recommendation about the SSA.

George Yuan: The SSA, those escalation will not be recommended after the disease progression. This growth is a result of our focus strategy focused on top tier city and top hospitals. Next slide. Looking to the future, sovleplenib, our SYK inhibitor, will bring us into the hematology immunology fields. This is the first-in-class medicine, and it can help patients to transform their treatment in both ITP and wAIHA. If we look at the ITP in China, we have 360,000 patients, and the current treatment, TPO-RA steroids, still cannot meet the medical needs of those patients. With these products, we provide a very unique value for those patients for long-term, stable, predictable disease control. Also for wAIHA, which is a relatively small indication, but it is under critical needs for new medicine.

Speaker #4: The SSA dose escalation will not be recommended after disease progression. And also, this growth is a result of our focused strategy, focusing on top-tier cities and the top hospitals.

Speaker #4: Next slide. Looking to the future, several plannable our SYK inhibitor will bring us into the hematology immunology fields. This is the first in first in class medicine.

Speaker #4: And it can help patients to transform their treatment in both in ITP and WAHA. If we look at the ITP in China, we have 360,000 patients and the current treatment TPOR steroids still cannot meet the medical needs of those patients.

Speaker #4: And with these products, we provide a very unique value for those patients for long-term stable predictable disease control. Also, for WAHA, which is a relatively small indication, but it's under critical needs for new medicine.

Speaker #4: We will be the first target therapy after 30 years in the field. And we will significantly reduce blood infusion for those patients. Now, I will hand over to our R&D, Dr. Dai.

George Yuan: We will be the first target therapy after 30 years in the field, and we will significantly reduce blood infusion for those patients. Now I will hand over to our R&D, Dr. Dai.

Speaker #2: Thank you, George. Now, let's transition into our R&D updates. Over the next few slides, I'll share how our late-stage clinical programs are progressing toward key commercial approvals and how our innovative platform is unlocking brand new opportunities to address major unmet medical needs.

Dr. Dai: Thank you, George. Now let's transition into our R&D updates. Over the next few slides, I will share how our late-stage clinical programs are progressing towards key commercial approvals, and how our innovative platform is unlocking brand new opportunities to address major unmet medical needs. Next slide, please. Looking at our recent achievements, we have hit several critical milestones across both solid tumors and hematology. Our novel ATTC platforms represent a huge strategic growth driver for us globally. The early biological profiles of ATTCs give us high confidence in their ability to target major solid tumors and differentiate from other ADC products. We have officially taken the first two ATTCs into the clinic, HMPL-A251 and HMPL-A580, initiating global phase I trials. The third ATTC, HMPL-A830, recently cleared the IND in both the US and in China. We secured approval for fruquintinib in renal cell carcinoma in June 2026.

Guangxiu Dai: Thank you, George. Now let's transition into our R&D updates. Over the next few slides, I will share how our late-stage clinical programs are progressing towards key commercial approvals, and how our innovative platform is unlocking brand new opportunities to address major unmet medical needs. Next slide, please. Looking at our recent achievements, we have hit several critical milestones across both solid tumors and hematology. Our novel ATTC platforms represent a huge strategic growth driver for us globally. The early biological profiles of ATTCs give us high confidence in their ability to target major solid tumors and differentiate from other ADC products. We have officially taken the first two ATTCs into the clinic, HMPL-A251 and HMPL-A580, initiating global phase I trials. The third ATTC, HMPL-A830, recently cleared the IND in both the US and in China. We secured approval for fruquintinib in renal cell carcinoma in June 2026.

Speaker #2: Next slide, please. Looking at our recent achievements, we've hit several critical milestones across both solid tumors and hematology. Our novel ATTC platforms represent a huge strategic growth driver for us globally.

Speaker #2: The early biological profiles of ATTCs give us high confidence in their ability to target major solid tumors and differentiate from other ADC products. We've officially taken the first two ATTCs into the clinic.

Speaker #2: A251 and A580 are initiating global Phase I trials. The third ATTC, A30, recently cleared the IND in both the US and China. We secured approval for Fruquintinib in renal cell carcinoma in June 2026.

Speaker #2: This is another important approval for frequented after CRC and EMC. With Serofenid, we have kept momentum strong with our phase three trial in first line PDAC fully on track, addressing an aggressive cancer pipe type with very few viable options.

Dr. Dai: This is another important approval for fruquintinib after CRC and ICC. With surufatinib, we have kept momentum strong with our phase III trial in first-line PDAC fully on track, addressing an aggressive cancer type with very few viable options. Savolitinib, our second inhibitor, is making rapid progress on lung cancer and autoimmune indications. The NDAs for ITP and wAIHA are currently under priority review. These mark huge steps towards establishing a new, highly effective standard of care in these conditions. The pivotal phase III data of ESLIM-02 was recently presented at EHA this year. Savolitinib expanded its commercial footprint with the third-line gastric cancer approval. This is the fourth regulatory approval for savolitinib after previous lung cancer approvals. HMPL-760, our potent PI3K/BTK inhibitor, successfully initiated its phase III trial in second-line DLBCL.

Guangxiu Dai: This is another important approval for fruquintinib after CRC and ICC. With surufatinib, we have kept momentum strong with our phase III trial in first-line PDAC fully on track, addressing an aggressive cancer type with very few viable options. Savolitinib, our second inhibitor, is making rapid progress on lung cancer and autoimmune indications. The NDAs for ITP and wAIHA are currently under priority review. These mark huge steps towards establishing a new, highly effective standard of care in these conditions. The pivotal phase III data of ESLIM-02 was recently presented at EHA this year. Savolitinib expanded its commercial footprint with the third-line gastric cancer approval. This is the fourth regulatory approval for savolitinib after previous lung cancer approvals. HMPL-760, our potent PI3K/BTK inhibitor, successfully initiated its phase III trial in second-line DLBCL.

Speaker #2: Salvo Planet, our second inhibitor, is making rapid progress on lung cancer and autoimmune indications. The NDAs for ITP and WAHA are currently under priority review.

Speaker #2: These mark huge steps towards establishing a new highly effective standard of care in these conditions. A pivotal phase three data of ifling two was recently presented at EHOT this year.

Speaker #2: Savolitinib expanded its commercial footprint with the third-line gastric cancer approval. This is the fourth regulatory approval for Savolitinib, after previous lung cancer approvals.

Speaker #2: And 760, our potent PI3-BTK inhibitor, successfully initiated its Phase III trial in second-line DLBCL. And surufatinib reached a pivotal moment with its NDA acceptance for FGFR-positive intrahepatic cholangiocarcinoma.

Dr. Dai: fanregratinib reached a pivotal moment with its NDA acceptance for FGFR-positive intrahepatic cholangiocarcinoma. The data was featured at ESMO GI this year. Together, these achievements reflect a highly efficient R&D engine, strengthening our commercial presence today, while laying the foundation for our global ATTC platform tomorrow. Next slide. Let's dive a bit deeper into our individual core assets, starting with savolitinib, our second potential global commercial product. Savolitinib targets lung cancer driven by MET alterations, which remains an area of significant unmet medical need. We are fast approaching several important milestones. In the H2 of this year, we expect data readouts from two key studies, SAFFRON on a global scale and SANOVO in China. SAFFRON is our global registration phase III trial. It targets second-line patients with EGFR-mutant non-small cell lung cancer who developed MET amplification or overexpression after progressing on TAGRISSO.

Guangxiu Dai: fanregratinib reached a pivotal moment with its NDA acceptance for FGFR-positive intrahepatic cholangiocarcinoma. The data was featured at ESMO GI this year. Together, these achievements reflect a highly efficient R&D engine, strengthening our commercial presence today, while laying the foundation for our global ATTC platform tomorrow. Next slide. Let's dive a bit deeper into our individual core assets, starting with savolitinib, our second potential global commercial product. Savolitinib targets lung cancer driven by MET alterations, which remains an area of significant unmet medical need. We are fast approaching several important milestones. In the H2 of this year, we expect data readouts from two key studies, SAFFRON on a global scale and SANOVO in China. SAFFRON is our global registration phase III trial. It targets second-line patients with EGFR-mutant non-small cell lung cancer who developed MET amplification or overexpression after progressing on TAGRISSO.

Speaker #2: The data was featured at ESMO GI this year. Together, these achievements reflect a highly efficient R&D engine strengthening our commercial presence today while laying the foundation for our global ATTC platform tomorrow.

Speaker #2: Next slide. Let's dive a bit deeper into our individual core assets, starting with Salvo Linit. Our second potential global commercial product. Salvo Linit targets lung cancer driven by met alterations, which remains an area of significant unmet medical need.

Speaker #2: We are fast approaching several important milestones. In a second half of this year, we expect data readouts from two key studies. Saffron on a global scale and Sanofo in China.

Speaker #2: Saffron is our global registration phase three trial it targets second line patients with EGFR mutant non-small cell lung cancer who developed met amplification or overexpression after progressing on Tagrisso.

Speaker #2: Currently, these patients are on very heavy chemotherapy. Saffron directly compares our oral combination of Salvo Linit plus Tagrisso against double chemotherapy. When approved, this trial will replace chemotherapy with an oral target option and opening access to major markets like the US and Europe.

Dr. Dai: Currently, these patients are on heavy chemotherapy. SAFFRON directly compares our oral combination of savolitinib plus TAGRISSO against double chemotherapy. When approved, this trial will replace chemotherapy with an oral target option and opening access to major markets like the US and Europe. SANOVO targets the first-line setting. We know that a significant subset of lung cancer patients present with coexisting EGFR mutations and MET overexpression right at initial diagnosis. SANOVO evaluates combining savolitinib with TAGRISSO directly upfront versus TAGRISSO alone. By attacking both targets from day one, our goal is to deliver deeper response and prevent resistance from emerging. Together with our proven phase III SACHI data, which shows a dramatic hazard ratio of 0.32 in PFS over chemotherapy, these upcoming readouts from SAFFRON and SANOVO position savolitinib to capture leadership across the entire treatment paradigm in MET-driven lung cancer. Next slide.

Guangxiu Dai: Currently, these patients are on heavy chemotherapy. SAFFRON directly compares our oral combination of savolitinib plus TAGRISSO against double chemotherapy. When approved, this trial will replace chemotherapy with an oral target option and opening access to major markets like the US and Europe. SANOVO targets the first-line setting. We know that a significant subset of lung cancer patients present with coexisting EGFR mutations and MET overexpression right at initial diagnosis. SANOVO evaluates combining savolitinib with TAGRISSO directly upfront versus TAGRISSO alone. By attacking both targets from day one, our goal is to deliver deeper response and prevent resistance from emerging. Together with our proven phase III SACHI data, which shows a dramatic hazard ratio of 0.32 in PFS over chemotherapy, these upcoming readouts from SAFFRON and SANOVO position savolitinib to capture leadership across the entire treatment paradigm in MET-driven lung cancer. Next slide.

Speaker #2: Sanofi targets the first-line setting. We know that a significant subset of lung cancer patients present with coexisting EGFR mutations and MET overexpression right at initial diagnosis.

Speaker #2: Sanofo evaluates combining Salvo Linit with Tagrisso directly upfront versus Tagrisso alone. Biotech in both targets from day one our goal is to deliver deeper response and prevent resistance from emerging.

Speaker #2: Then together with our proven phase three statutory data, which shows a dramatic hazard ratio of 0.32 in PFS over chemotherapy, this upcoming readouts from Saffron and Sanofo position Salvo Linit to capture leadership across the entire treatment paradigm in met driven lung cancer.

Speaker #2: Next slide. This slide highlights Salvo Planet, which is spearheading our next wave of hematology and autoimmune products. WAHA is a debilitating disease where red blood cells are destroyed prematurely, leaving patients severely anemic and often relying on high-dose steroids and frequent blood transfusions.

Dr. Dai: This slide highlights sovleplenib, which is spearheading our next wave of hematology and autoimmune products. wAIHA is a debilitating disease where red blood cells are destroyed prematurely, leaving patients severely anemic and often they rely on high dose steroids and frequent blood transfusions. In our phase III ESLIM-02 study presented at EHA, sovleplenib achieved a 66% durable response rate compared to 15% in the placebo group. Patients on sovleplenib reached target hemoglobin levels in a median of 3.1 weeks, twice as fast as the placebo. Substantial drop in rescue therapy and transfusion. Only 16% of sovleplenib patients require rescue therapy compared to 54% on the placebo. Furthermore, Red blood cell transfusions were significantly reduced to just 11% versus 43% in the control group, allowing the patients to taper or completely discontinue their baseline steroids.

Guangxiu Dai: This slide highlights sovleplenib, which is spearheading our next wave of hematology and autoimmune products. wAIHA is a debilitating disease where red blood cells are destroyed prematurely, leaving patients severely anemic and often they rely on high dose steroids and frequent blood transfusions. In our phase III ESLIM-02 study presented at EHA, sovleplenib achieved a 66% durable response rate compared to 15% in the placebo group. Patients on sovleplenib reached target hemoglobin levels in a median of 3.1 weeks, twice as fast as the placebo. Substantial drop in rescue therapy and transfusion. Only 16% of sovleplenib patients require rescue therapy compared to 54% on the placebo. Furthermore, Red blood cell transfusions were significantly reduced to just 11% versus 43% in the control group, allowing the patients to taper or completely discontinue their baseline steroids.

Speaker #2: In our phase three, ifling two study presented at EHOT, Salvo Planet achieved a 66% durable response rate compared to 15% in the placebo group.

Speaker #2: Patients on Salvo Planet reached target hemoglobin levels in a median of 3.1 weeks twice as fast as the placebo. Substantial drop in rescue therapy and transfusion only 16% of Salvo Planet patients required rescue therapy compared to 54% on the placebo.

Speaker #2: And furthermore, red blood cell transfusions were significantly reduced to just 11% versus 43% in the control group, allowing the patients to taper or completely discontinue their baseline steroids.

Speaker #2: Then when you compare this to the emerging peer options like NipokeliMAP, Salvo Planet shows a clear competitive efficacy. Advantage delivering a much higher durable response rate without forcing patients to stay on chronic high risk immunosuppressants.

Dr. Dai: When you compare this to the emerging peer options like nipocalimab, sovleplenib shows a clear comparative efficacy advantage, delivering a much higher durable response rate, without fear of forcing patients to stay on chronic high-risk immunosuppressants. We are eager to bring sovleplenib to a patient population that hasn't seen a new target therapy option in 30 years. Currently, the NDA is under priority review. In ITP, with that, sovleplenib, apart from standard care agents like TPOs and TPO-RAs, is exceptional efficacy without associated thrombotic complication warnings found on their peer labels. In ITP, sovleplenib achieves a striking durable response rate compared to placebo, even though 75% of the enrolled patients had failed prior TPO therapies. It's in one study. It's also under priority review in China. Next slide.

Guangxiu Dai: When you compare this to the emerging peer options like nipocalimab, sovleplenib shows a clear comparative efficacy advantage, delivering a much higher durable response rate, without fear of forcing patients to stay on chronic high-risk immunosuppressants. We are eager to bring sovleplenib to a patient population that hasn't seen a new target therapy option in 30 years. Currently, the NDA is under priority review. In ITP, with that, sovleplenib, apart from standard care agents like TPOs and TPO-RAs, is exceptional efficacy without associated thrombotic complication warnings found on their peer labels. In ITP, sovleplenib achieves a striking durable response rate compared to placebo, even though 75% of the enrolled patients had failed prior TPO therapies. It's in one study. It's also under priority review in China. Next slide.

Speaker #2: We are eager to bring Salvo Planet to a patient population that hasn't seen a new targeted therapy option in 30 years, and currently, the NDA is under priority review.

Speaker #2: In ITP, what sets Salvo Planet apart from standard-of-care agents like TPOs and TPO-RAs is exceptional efficacy without the associated thromboembolic complication warnings found on their peer labels.

Speaker #2: In ITP, Salvo Planet achieved a striking durable response rate compared to placebo even though 75% of the enrolled patients had failed prior TPO therapies.

Speaker #2: Ifling one study is also under priority review in China. Next slide. Then turning to slide 17, let's look at 760, our highly potent selective and reversible BTK inhibitor characterized by long target engagement.

Dr. Dai: turning to slide 17, let's look at 760, our highly potent, selective, and reversible BTK inhibitor characterized by long target engagement. Currently, this is the only BTK inhibitor in late-stage clinical development targeting the second-line DLBCL all comers. Our phase II study showed an encouraging response rate, PFS, and safety profile. Our phase III registration study in China is actively ongoing, comparing 760 in combination with R-GemOx against the placebo plus R-GemOx, with primary endpoints of PFS and OS. We expect to complete enrollment by the end of 2027. Next slide, please. Here, I want to highlight our novel ATTC platform, starting with A251. ADCs like ENHERTU have transformed HER2-positive cancer treatment, generating billions in revenue. However, acquired resistance to DXd, the cytotoxic payload used in ENHERTU, remains a major clinical hurdle as patients inevitably progress.

Guangxiu Dai: turning to slide 17, let's look at 760, our highly potent, selective, and reversible BTK inhibitor characterized by long target engagement. Currently, this is the only BTK inhibitor in late-stage clinical development targeting the second-line DLBCL all comers. Our phase II study showed an encouraging response rate, PFS, and safety profile. Our phase III registration study in China is actively ongoing, comparing 760 in combination with R-GemOx against the placebo plus R-GemOx, with primary endpoints of PFS and OS. We expect to complete enrollment by the end of 2027. Next slide, please. Here, I want to highlight our novel ATTC platform, starting with A251. ADCs like ENHERTU have transformed HER2-positive cancer treatment, generating billions in revenue. However, acquired resistance to DXd, the cytotoxic payload used in ENHERTU, remains a major clinical hurdle as patients inevitably progress.

Speaker #2: Currently, this is the only BTK inhibitor in late-stage clinical development targeting second-line DLBCL. All commers. Our phase 2 study showed encouraging response rate, PFS, and safety profile.

Speaker #2: Our phase three registration study in China is actively ongoing comparing 760 in combination with RGMOX against the placebo plus RGMOX. With primary endpoints of PFS and OS.

Speaker #2: And we expect to complete enrollment by the end of 2027. Next slide, please. Here, I want to highlight our novel ATTC platform, starting with A251.

Speaker #2: ADCs like in HER2 have transformed HER2 policies cancer treatment generating billions in revenue. However, acquired resistance to DXC, the cytotoxic payload used in HER2 remains a major clinical hurdle as patients inevitably progress.

Speaker #2: The DXC induced in the resistant model on the bottom shows that in HER2, potency is almost completely lost, shifting the curve far to the right. In the same resistant cell model, because A251 utilizes a completely distinct mechanism—targeting the PFAK and PAKK signaling pathways rather than DNA-damaging toxins—

Dr. Dai: The DXd induced in resistant model on the bottom show that ENHERTU loses potency almost completely, shifting the curve far to the right. In the same resistant cell models, because A251 utilizes a completely distinct mechanism targeting the PI3K and PI3K signaling pathways rather than DNA-damaging toxins, its killing activity in DXd-resistant cells, shown in the green curve, remains identical to DXd-sensitive parent cells, shown in the blue curve. Next slide. Beyond treating drug-resistant tumors, A251 has strong potential as a front-line treatment. As shown in these gynecological cancer and GI cancer xenograft models, combining A251 with the first-line standard of care yields significant tumor volume reduction compared to either therapy alone.

Guangxiu Dai: The DXd induced in resistant model on the bottom show that ENHERTU loses potency almost completely, shifting the curve far to the right. In the same resistant cell models, because A251 utilizes a completely distinct mechanism targeting the PI3K and PI3K signaling pathways rather than DNA-damaging toxins, its killing activity in DXd-resistant cells, shown in the green curve, remains identical to DXd-sensitive parent cells, shown in the blue curve. Next slide. Beyond treating drug-resistant tumors, A251 has strong potential as a front-line treatment. As shown in these gynecological cancer and GI cancer xenograft models, combining A251 with the first-line standard of care yields significant tumor volume reduction compared to either therapy alone.

Speaker #2: It's killing activity in DXC resistant cells shown in the green curve remains identical to DXC sensitive parent cells shown in the blue curve. Next slide.

Speaker #2: In addition to treating drug-resistant tumors, A251 has strong potential as a frontline treatment. As shown in these gynecological cancer and GI cancer xenograft models, combining A251 with the first-line standard of care yields significant tumor volume reduction compared to either therapy alone.

Speaker #2: And crucially, this synergistic effect does not come as the cost of added toxicity. Proving A251 can safely be combined which is what we aim to achieve with ATTCs in the first place.

Dr. Dai: Crucially, this synergistic effect does not come at the cost of added toxicity, proving A251 can safely be combined, which is what we aim to achieve with ATTCs in the first place, which is better efficacy and better safety. Our clinical strategy is twofold. A monotherapy track for a fast-to-market approach in late-line setting, and a combination track targeting front-line indications. Our extensive preclinical data supports the A251 development strategy. The clinical trial is on track at dose escalation stage. Next slide. Our second ATTC asset is 580, which pairs the same payload with an EGFR-targeting antibody. Blockbuster drugs like TAGRISSO treat EGFR mutant non-small cell lung cancer, but resistance eventually develops. In a non-small cell lung cancer model carrying the challenging, EGFR exon 19 deletion and the resistant mutation, third-generation TKIs like TAGRISSO completely lose control of tumor growth, as shown by the red curve.

Guangxiu Dai: Crucially, this synergistic effect does not come at the cost of added toxicity, proving A251 can safely be combined, which is what we aim to achieve with ATTCs in the first place, which is better efficacy and better safety. Our clinical strategy is twofold. A monotherapy track for a fast-to-market approach in late-line setting, and a combination track targeting front-line indications. Our extensive preclinical data supports the A251 development strategy. The clinical trial is on track at dose escalation stage. Next slide. Our second ATTC asset is 580, which pairs the same payload with an EGFR-targeting antibody. Blockbuster drugs like TAGRISSO treat EGFR mutant non-small cell lung cancer, but resistance eventually develops. In a non-small cell lung cancer model carrying the challenging, EGFR exon 19 deletion and the resistant mutation, third-generation TKIs like TAGRISSO completely lose control of tumor growth, as shown by the red curve.

Speaker #2: Which is better efficacy and better safety. Our clinical strategy is twofold. A to market approach in lay line setting and the combination track targeting frontline indications.

Speaker #2: And our extensive preclinical data support the A251 development strategy. The clinical trial is on track at dose escalation stage. Next slide. Our second ATTC asset is 580, which pairs the same payload with an EGFR targeting antibody.

Speaker #2: Blockbuster drugs like Tagrisso treat EGFR mutant long small cell lung cancer but resistance eventually develops in a non-small cell lung cancer model carrying the challenging EGFR exon 19 deletion and the resistant mutation third generation TKIs like Tagrisso completely lose control of tumor growth as shown by the red curve.

Speaker #2: 580 represented by the blue curve achieved profound and sustained tumor regression at the single agent. This highlights its enormous potential for lung cancer patients.

Dr. Dai: 580, represented by the blue curve, achieved profound and sustained tumor regression as a single agent. This highlights its enormous potential for lung cancer patients. Next slide. Combining 580 with an EGFR inhibitor, we can simultaneously shut down primary receptor signaling and the downstream escape pathways. The preclinical data reflects a highly significant synergistic anti-tumor efficacy, supporting our long-term plan to move this asset into front-line cancer regimens. This global asset entered phase I trial earlier this year. The trial is going very well, recruiting patients from China sites and the US sites in parallel. Next slide. What makes our ATTC platform so unique is the payload itself. Historically, the industry has struggled with pan pathways, pan PI3K or dual PI3K inhibitors, and toxic small molecules were simply too toxic to be delivered systemically, resulting in severe side effects like hyperglycemia or mucositis.

Guangxiu Dai: 580, represented by the blue curve, achieved profound and sustained tumor regression as a single agent. This highlights its enormous potential for lung cancer patients. Next slide. Combining 580 with an EGFR inhibitor, we can simultaneously shut down primary receptor signaling and the downstream escape pathways. The preclinical data reflects a highly significant synergistic anti-tumor efficacy, supporting our long-term plan to move this asset into front-line cancer regimens. This global asset entered phase I trial earlier this year. The trial is going very well, recruiting patients from China sites and the US sites in parallel. Next slide. What makes our ATTC platform so unique is the payload itself. Historically, the industry has struggled with pan pathways, pan PI3K or dual PI3K inhibitors, and toxic small molecules were simply too toxic to be delivered systemically, resulting in severe side effects like hyperglycemia or mucositis.

Speaker #2: Next slide. Then combining 580 with an EGFR inhibitor we can simultaneously shut down primary receptor signaling and the downstream escape pathways. The preclinical data reflects a highly significant synergistic anti-tumor efficacy supporting our long-term plan to move this asset into frontline cancer regimens.

Speaker #2: This global asset enter phase one trial earlier this year the trial is going very well recruiting patients from China sites and the US sites in parallel.

Speaker #2: Next slide. What makes our ATTC platform so unique is the payload itself. Historically, the industry has struggled with PEM pathways, PEM, PFAK or dual PFAK, and TORI small molecules were simply too toxic to be delivered systemically.

Speaker #2: This resulted in severe side effects like hyperglycemia and mucositis. Single-node inhibitors were safer, but their efficacy was limited. Our innovation was to design a highly selective payload that targets multiple key nodes.

Dr. Dai: Single node inhibitors were safer, but their efficacy was limited. Our innovation was to design a highly selective payload that harvests multiple key nodes along both the PI3K and PIKK pathways with very high affinity, and then tether it to an antibody. This ensures the payload is delivered inside the tumor cells, maximizing intracellular kinase inhibition while sparing healthy tissues from systemic toxicities. The kinesin tree on the right illustrates its high selectivity of the payload. Next slide. The ATTC approach opens up massive opportunities. The pan pathway is the single most frequently altered pathway across all solid tumors. It plays a dominant role in breast cancer, lung cancer, gastric, and ovarian cancers. By effectively targeting this pathway with our ATTC technology, we can potentially reach millions of patients across a wide range of cancer types. Next slide.

Guangxiu Dai: Single node inhibitors were safer, but their efficacy was limited. Our innovation was to design a highly selective payload that harvests multiple key nodes along both the PI3K and PIKK pathways with very high affinity, and then tether it to an antibody. This ensures the payload is delivered inside the tumor cells, maximizing intracellular kinase inhibition while sparing healthy tissues from systemic toxicities. The kinesin tree on the right illustrates its high selectivity of the payload. Next slide. The ATTC approach opens up massive opportunities. The pan pathway is the single most frequently altered pathway across all solid tumors. It plays a dominant role in breast cancer, lung cancer, gastric, and ovarian cancers. By effectively targeting this pathway with our ATTC technology, we can potentially reach millions of patients across a wide range of cancer types. Next slide.

Speaker #2: Along both the PFAK and PAKK pathways with very high affinity, and then tether it to an antibody. This ensures the payload is delivered inside the tumor cells, maximizing intracellular kinase inhibition while sparing healthy tissues from systemic toxicities.

Speaker #2: The kinase tree on the right illustrates this high selectivity of the payload. Next slide. The ATTC approach opens up massive opportunities. The PEM pathway is the single most frequently altered pathway across all solid tumors.

Speaker #2: It plays a dominant role in breast cancer, lung cancer, gastric, and ovarian cancers. By effectively targeting this pathway with our ATTC technology, we can potentially reach millions of patients across a wide range of cancer types.

Speaker #2: Next slide. With A251 and 580 currently in global trials, A30 entering the clinic soon, and more candidates behind them, our pipeline is well-positioned to deliver sustained growth for years to come.

Dr. Dai: With A251 and 580 currently in global trials, A830 entering the clinic soon, and more candidates behind them, our pipeline is well positioned to deliver a sustained growth for years to come. Thank you, and I'll give it back to Johnny.

Guangxiu Dai: With A251 and 580 currently in global trials, A830 entering the clinic soon, and more candidates behind them, our pipeline is well positioned to deliver a sustained growth for years to come. Thank you, and I'll give it back to Johnny.

Speaker #2: Thank you and I'll give it back to John.

Speaker #1: Thank you. Dr. Dai, a quick highlight on our outlook. So on the innovation side, as mentioned by Dr. Dai, multiple ATTC programs are progressing well.

Johnny Cheng: Thank you, Dr. Dai. A quick highlight on our outlook. On the innovation side, as mentioned by Dr. Dai, multiple ATTC programs are progressing well. We believe around this time next year, there should be a total of five programs already in clinics. More importantly, our efforts in AI will be transforming and accelerating further discovery and development in our innovation platform. On the commercial side, we expect Fuzecca's sales growth to continue. We anticipate it will reach its next sales milestone in the near term. Regarding our hematology portfolio, our commercial team is preparing for the launch of our immunology asset, which is anticipated to commence next year. Finally, we are continuing to engage many multinational companies on collaboration discussion regarding our ATTC program. I will now pass it back to David to begin our Q&A session.

Speaker #1: And we believe that around this time next year, there should be a total of five programs already in clinics. More importantly, our efforts in AI will be transforming and accelerating further discovery and development in our innovation platform.

Speaker #1: On the commercial side, we expect FUSEKA's sales growth to continue. We anticipate it will reach its next sales milestone in the near term. Regarding our hematology portfolio, our commercial team is preparing for the launch of our immunology asset.

Speaker #1: Which is anticipated to commence next year. And finally, we are continuing to engage many multinational companies on collaboration discussion. Regarding our ATTC program. I will now pass it back to David to begin our Q&A session.

Speaker #3: Thank you, Johnny. We will now start our Q&A session. Before we start, I'll just would like to repeat the instructions to ask questions. On the bottom of your screen, you can see the raised hand button.

David Ng: Thank you, Johnny. We will now start our Q&A session. Before we start, I would like to repeat the instructions to ask questions. On the bottom of your screen, you can see the raise hand button. Just press on the button, and we will call out your name and unmute your line. When you start, please do mention the name of your company as well as your name. The first question comes from Matthew of CLSA. Matthew, you can now go ahead and talk. Thanks.

Speaker #3: Just press on the button and we will call out your name and unmute your line. And when you start, please do mention the name of your company as well as your name.

Speaker #3: So the first question comes from Matthew of CLSA. Matthew, you can now talk. Thanks.

Speaker #4: Hi, thank you for taking my question. This is Matthew from CLSA. I have three questions. First is regarding the collaboration opportunities for the ATTC programs—two in clinic, one about to be in clinic—so Q1, Q1. More on the kind of progress, because I think there's been some expectation on maybe early stage collaboration before.

[Analyst] (CLSA): Thank you for taking my question. This is Matthew from CLSA. I have three questions. First is regarding the collaboration opportunity for the ATTC programs, two in clinic and one about to be in clinic. Could you elaborate more on the kind of progress, because I think that there's been some expectation on the maybe earlier stage of collaboration before. Yeah, can you comment on that? Second one is regarding your HMPL-760, the BTK inhibitor. Yeah, as you mentioned, you have initiated a phase III trial for DLBCL in China. May I understand how is this drug different from other BTK inhibitors, and why would you choose the DLBCL to proceed for phase III as there are no other BTK inhibitors approved for these indications, including the covalent ones and also the non-covalent ones that are non-approved?

Speaker #4: So yeah, can you comment on that? And the second one is regarding your HMPL-760, the BTK inhibitor. Yeah, as you mentioned, you have initiated the Phase III trial for DLBCL in China.

Speaker #4: And may I understand how is this drug different from other BDK inhibitors and why would you choose the DLBCL to proceed for phase three as there are no other BDK inhibitors approved for this indications including the covalent ones and also the non-covalent ones, none are approved.

Speaker #4: And the third question is regarding the on the financial side, I know that the other ventures is a low margin distribution business, but may I still have some color on why in first half is on a constant exchange rate basis declined by almost 20%.

[Analyst] (CLSA): The third question is regarding on the financial side. I know that the other ventures is a low margin distribution business, may I still have some color on why in the H1 is on a constant exchange rate basis declined by almost 20%? Okay, that's my question. Thank you.

Speaker #4: Okay, that's my question. Thank you.

Speaker #1: Thank you, Matthew. So, I will invite Dr. Dai to answer the second question, and Lorenzo to answer the last question. Regarding the first question about collaboration opportunities, basically, we are continuing and we have active multinational companies engaging in discussions with us on not just one program, but multiple ATTC programs.

Johnny Cheng: Thank you, Matthew. I will invite Dr. Dai to answer the second question and Lorenzo to answer the last question. The first question regarding the collaboration opportunity, basically, we are continuing, and we have active multinational companies engaging in discussion with us on not just one program, but multiple ATTC programs. As you know that our programs are still at the very early stage, different expectation in terms of timeline and information to be provided from our side to the collaborate potential partners. They have kind of different requirements. All I can say right now it is we are in active discussions with multiple parties, and the discussions are progressing well. The discussions is coming to a close to mature and is disclosable items, then we will be making an announcement to the public.

Speaker #1: As you know, our programs are still at a very early stage, so there are different expectations in terms of timeline and information to be provided.

Speaker #1: From our side to the collaborate they have kind of different requirements. So I all I can say right now it is we are in an active discussions with the multiple parties and the discussions are progressing well.

Speaker #1: When I think the discussions are coming to a close, to mature and disclosable items, then we will be making an announcement to the public.

Speaker #1: Maybe Dr. Dai, you can answer the question number two regarding the 760 BDK.

Johnny Cheng: Maybe Dr. Dai, you can answer the question number 2 regarding the HMPL-760 BTK.

Speaker #2: Sure. Sure, Johnny. So yes, we are we have actually started phase three study with 760. It is a combination of 760 plus RGMOX versus RGMOX.

Dr. Dai: Sure, Johnny. Yes, we have actually started phase III study with HMPL-760. It is a combination of HMPL-760 plus R-GemOx versus R-GemOx. We pick DLBCL obviously because it's the largest lymphoma subtype, accounting for about 40% of lymphoma, and no other BTK inhibitors has been approved for this particular subtype of lymphoma. It represents a huge unmet medical need and good market potential. With our HMPL-760, it's reversible BTK inhibitor. In earlier clinical study, it demonstrated a very good selectivity and safety profile. We actually had phase II study validating its efficacy in the second line setting. It is the same study design, and we achieved a very impressive overall response rate and the CR rate, and a very favorable safety profile to encourage us to go into the phase III study.

Guangxiu Dai: Sure, Johnny. Yes, we have actually started phase III study with HMPL-760. It is a combination of HMPL-760 plus R-GemOx versus R-GemOx. We pick DLBCL obviously because it's the largest lymphoma subtype, accounting for about 40% of lymphoma, and no other BTK inhibitors has been approved for this particular subtype of lymphoma. It represents a huge unmet medical need and good market potential. With our HMPL-760, it's reversible BTK inhibitor. In earlier clinical study, it demonstrated a very good selectivity and safety profile. We actually had phase II study validating its efficacy in the second line setting. It is the same study design, and we achieved a very impressive overall response rate and the CR rate, and a very favorable safety profile to encourage us to go into the phase III study.

Speaker #2: We pick a DLBCL obviously because it's the largest lymphoma subtype counting for about 40% of lymphoma. And no other BDK inhibitors has been approved in for this particular subtype of lymphoma.

Speaker #2: So it represents a huge unmet medical need and good market potential. And with our 760, it's a reversible BDK inhibitor, and in earlier clinical study, it demonstrated a very good selectivity and safety profile.

Speaker #2: And we actually had a phase two study validating its efficacy in the second-line setting. It is the same study design, and we achieved a very impressive overall response rate and CR rate, and a very favorable safety profile, which encouraged us to go into the phase three study.

Speaker #2: So, it is a very exciting opportunity for 760, and we hope to achieve the enrollment completion as quickly as we can. Thank you.

George Yuan: It is a very exciting opportunity for HMPL-760, and we hope to achieve the enrollment completion as fast as we can. Thank you.

Speaker #3: Yep. Johnny will answer question three. As for the other ventures, I think you're right to point out that other ventures business which is not our focus.

Lorenso Chiu: Yep. Johnny, I'll answer question three. As for the other ventures, I think you're right to point out that our other ventures is a low margin business, which is not our focus. We are putting our focus on our major ongoing revenues. As you can see, the growth is there, and that's the reason that there was some decline in the other ventures business. I don't think we need to look into too much about behind this because as you said, it's low margin and it's not our core.

Speaker #3: We are putting our focus on major college revenues. As you can see, the growth is there, and that's the reason there was some decline in the other ventures business.

Speaker #3: But I don't think we need to look into too much about behind this because as I said, it's low margin and it's not our core.

Speaker #1: Maybe I’ll just supplement that. I think, as highlighted by Lorenzo, this is not our core business, and it is basically a logistics distribution business.

Johnny Cheng: Maybe I just supplement that. I think, as highlighted by Lorenzo, this is not our core business. It is basically a logistic distribution business. The reason that it has been some decline is because of the volume-based procurement list has actually in China have been expanded. Some of the previously our customers in the logistic distribution side have actually affected by the volume-based procurement in terms of the selling price and so forth. That services business is not what we focus basically because of the high working capital requirement for this business. As a way to manage this business, we try to just maintain this line of business to help to gain insight into the commercial channel in Shanghai. I think that the drop, it doesn't actually affect the bottom line, doesn't affect in terms of the entire business operation of HUTCHMED.

Speaker #1: The reason that it has been some decline is because of the volume-based procurement list has actually in China have been expanded. So some of the previously our customers in the logistic distribution side have actually affected by the volume-based procurement.

Speaker #1: In terms of the selling price and so forth. So that surfaces business is not what we focus because of the basically because of the high working capital requirement for this business.

Speaker #1: So as a way to manage this business, we try to just maintain this line of business to help to gain insights into the commercial channel in Shanghai.

Speaker #1: So I think that the job it doesn't actually affect the bottom line. It doesn't affect in terms of the entire business operation of HUTCHMED.

Speaker #4: Okay, that's very clear. Thank you very much.

[Analyst] (CLSA): Okay, that's very clear. Thank you very much.

Speaker #3: Thank you. Thank you, Matthew. Thank you, Johnny. So the next question is from Chen Chen of UBS. Chen Chen, we will now open up your line.

David Ng: Thank you, Matthew. Thank you, Johnny. The next question is from Chen Chen of UBS. Chen Chen, we will now open up your line. Your line is now unmuted.

Speaker #3: Your line is now on mute.

Chen Chen: Sure. Thank you for taking my questions. My first question is on sovleplenib. This candidate is expected to receive approval next year. Could you please elaborate on your commercial preparation strategy in China, including pricing, marketing access and NRDL, and your sales force? In addition, what are your overseas R&D plans and priorities for this asset? My second question is on ATTC. Well, what is the expected timeline for clinical data readout from your candidate one and two? Thank you.

Speaker #5: Sure. Thank you for taking my questions. So my first question is on soft laminate. So this candidate is expected to receive approval next year?

Speaker #5: Could you please elaborate on your commercial preparation strategy in China including pricing? and RDL and your Salesforce in addition, what are your overseas R&D plans and priorities for this asset?

Speaker #5: My second question is on ATTC. Well, so what is the expected timeline for clinical data result from your candidate one and two? Thank you.

Speaker #1: Thank you. So may I ask George to answer the first question and Dr. Dai to the second question?

Johnny Cheng: Thank you. May I ask George to answer the first question and Dr. Dai do the second question?

Speaker #2: Yeah. Thanks for launch preparation. We are focused on few area. One is market access. Value proposition. We need to make sure this product is going to the other and we expect this product to get approval maybe in the first half of this year and next year and qualify for the other negotiation.

George Yuan: Yeah. Thanks, Chen Chen. For sovleplenib launch preparation, we are focused on few area. First thing is market access, value proposition. We need to make sure this product's going to the NRDL, and we expect this product to get approval maybe in H1 of next year and qualify for the NRDL negotiation. One of the challenges is how can we position us very well to achieve affordable and realistic price in this disease. One of the understanding is we will do a kind of EHR data based on our clinical trial.

Speaker #2: One of the challenges is how can we position us very well to achieve affordable and realistic price. In this disease, one of the understanding is we will do kind of HUR data based on our clinical trial.

Speaker #2: On the other side, we also would like to work with patient group with opinion leaders to understand the pain points of the current treatment and try to make sure we really leverage those patient insights to make sure the government understand there's many needs and there's a quality of life kind of compromising for those patients who receive other treatments.

George Yuan: On the other side, we also would like to work with a patient group with opinion leaders to understand the pain points of the current treatment and try to make sure we really leverage those patient insights to make sure the government understand there's unmet needs and there's a quality of life kind of compromising for those patients who receive other treatments. This will help us to leverage the future. On the other side, we definitely will do the guideline, we do the KOL, and as well as a physician education program, also a patient advocacy group as well. If we look at the current setup for the launch, we have already built up a dedicated hematology team with a lot of experienced people in the hematology side.

Speaker #2: So this will help us to leverage the future. On the other side, we definitely will do the guideline. We do the KTL and as well as physician education program also patient advocacy group as well.

Speaker #2: And if we look at the current setup for the launch, we have already built up a dedicated hematology team with a lot of experienced people in the hematology side.

Speaker #2: We are starting to work with our partners to understand the market potential, try to figure out what's our first wave target hospitals territories and the resource deployment.

George Yuan: We are starting to work with our partners to understand the market potential, try to figure out what's our first wave target hospitals, territories, and the resource deployment.

Speaker #2: Okay. I'll get the second question. So the first and second ATTC assets are both in the middle of phase one, dose escalation. The trials are moving very fast.

Dr. Dai: Okay, I'll take the second question. The first and second ATTC assets are both in the middle of phase I dose escalation. The trials are moving very fast. Enrollment has been going strong in the US and in China sites. Investigators are very excited about the novel mechanisms and the differentiation. They understand the rationale and they are enthusiastic about the immune mechanism of the ATTC. We will find the right time to disclose the clinical data sometime in 2027. Thank you.

Guangxiu Dai: Okay, I'll take the second question. The first and second ATTC assets are both in the middle of phase I dose escalation. The trials are moving very fast. Enrollment has been going strong in the US and in China sites. Investigators are very excited about the novel mechanisms and the differentiation. They understand the rationale and they are enthusiastic about the immune mechanism of the ATTC. We will find the right time to disclose the clinical data sometime in 2027. Thank you.

Speaker #2: Enrollment has been going strong in the US and in China sites investigators are very excited about the novel mechanisms and the differentiation. The understand the rationale and they are enthusiastic about the new mechanism of the ATTCs.

Speaker #2: So we will find the right time to disclose the clinical data sometime in 2027. Thank you.

Chen Chen: Got it. Thanks, George and Dr. Dai.

Speaker #5: Got it. Thanks, George and Dr. Dai.

Speaker #2: Thank you.

Dr. Dai: Thank you.

Guangxiu Dai: Thank you.

Speaker #3: Thank you, Chen Chen. The next question comes from Fo Choi of Goldman Sachs. Oh, go ahead. Yes, we can. Thanks.

David Ng: Thank you, Qianqian. The next question comes from Paul Choi of Goldman Sachs. Oh, go ahead.

Paul Choi: Hi, can you hear me?

David Ng: Yes, we can.

Speaker #6: Hi. Thank you. Good morning. Good evening. I want to talk a little bit about first ask on sulfa and as you sort of look at the warm autoimmune hemolytic anemia landscape.

Paul Choi: Hi. Thank you. Good morning, good evening. I want to talk a little bit about, first ask on sovleplenib, as you sort of look at the warm autoimmune hemolytic anemia landscape, and just sort of the other products or candidates that are in that category, how do you think about potential developments and planning for a global trial outside of China? Just sort of any additional thoughts on what aspects or differentiation are needed there. Then I had a follow-up question.

Speaker #6: And just sort of the other products or candidates that are in that category. How do you think about potential developments and planning for a global trial outside of China and just sort of any additional thoughts on what aspects or differentiation are needed there?

Speaker #6: And then as a follow-up question.

Speaker #1: Dr. Dai? Yeah. Yeah.

Johnny Cheng: Dr. Dai? Yeah.

Dr. Dai: Of course.

Guangxiu Dai: Of course.

Johnny Cheng: George, yeah.

Speaker #2: So 523 now both studies in ITP and YHAR were completed in China. We are waiting for CDEs feedback on our NDA data. But in the ex-China, we are our strategy is to develop this asset through partnership.

Dr. Dai: 523, now both studies in ITP and wAIHA were completed in China. We are waiting for CDE's feedback on our NDA data. In ex-China, our strategy is to develop this asset through partnership.

Guangxiu Dai: 523, now both studies in ITP and wAIHA were completed in China. We are waiting for CDE's feedback on our NDA data. In ex-China, our strategy is to develop this asset through partnership.

Speaker #3: Thank you.

Paul Choi: Thank you. Any thoughts on, again, sort of what clinical differentiation might be needed versus development strategy?

Speaker #6: But any thoughts on, again, sort of what clinical differentiation might be needed versus development strategy?

Speaker #2: Right now, the treatment paradigm for, for example, for YHAR, the first line is mainly the steroids. Like George mentioned earlier, and we are targeting the second line patients, which doesn't have.

Dr. Dai: Right now, the treatment paradigm, for example, for wAIHA, the first line is mainly the steroids, like George mentioned earlier. We are targeting the second line of patients, which doesn't have a lot of choices other than the steroids. The online mechanism is very high in China as well as in the US. As you can tell from our phase III data, the overall durable response rate looks very promising compared to the other competitors, which is FcRn antibody product. We think this asset has great potential, so we are actively looking for partnership to co-develop this asset outside China.

Guangxiu Dai: Right now, the treatment paradigm, for example, for wAIHA, the first line is mainly the steroids, like George mentioned earlier. We are targeting the second line of patients, which doesn't have a lot of choices other than the steroids. The online mechanism is very high in China as well as in the US. As you can tell from our phase III data, the overall durable response rate looks very promising compared to the other competitors, which is FcRn antibody product. We think this asset has great potential, so we are actively looking for partnership to co-develop this asset outside China.

Speaker #2: There are a lot of choices other than steroids. The online mechanism is very high in China as well as in the US. And as you can tell from our Phase 3 data, the overall durable response rate looks very promising compared to other competitors.

Speaker #2: Which is a CRN antibody product. So we think this asset has great potential. We are actually looking for partnership to co-develop this asset outside China.

Speaker #1: Yeah. Maybe I can add because

George Yuan: Maybe I can add, because this wAIHA is regarded as a rare disease, we also have a plan to apply US orphan drugs status.

Speaker #4: This YHAR is regarded as a rare disease, and we also have a plan to apply for US orphan drug status.

Speaker #6: Okay, great. Thanks for that clarification. My second question is on HMPL-453, specifically regarding regotinib. You have advanced it through the second-line ICC population on the oncology side, but I want to ask what your thoughts are on potential endocrinology applications, such as achondroplasia and other bone growth disorders?

Paul Choi: Thanks for that clarification. My second question is on fanregratinib. You advanced it through the second-line ICC population on the oncology side. I want to ask what your thoughts are on potential endocrinology applications, such as achondroplasia and other bone growth disorders, and if you think this might be a potentially appropriate candidate there. Thank you.

Speaker #6: And if you think this might be a potentially appropriate candidate there. Thank you.

Speaker #2: With 453, our main focus right now is intrahepatic cholangiocarcinoma, second line. And we have started the confirmatory trial to get this indication confirmed in the same setting.

Dr. Dai: With HMPL-453, our main focus right now is intrahepatic cholangiocarcinoma, second-line. We have started the confirmatory trial to get this indication confirmed in the same setting. Thank you.

Guangxiu Dai: With HMPL-453, our main focus right now is intrahepatic cholangiocarcinoma, second-line. We have started the confirmatory trial to get this indication confirmed in the same setting. Thank you.

Speaker #2: Thank you.

Speaker #6: Thank you.

Paul Choi: Thank you.

Speaker #3: Thank you, Paul. The next question comes from Adam McCarter of Cavendish. Adam, your line is now unmuted.

David Ng: Thank you, Paul. The next question comes from Adam McCarter of Cavendish. Adam, your line is now unmuted.

Speaker #7: Hi there. Yeah, thanks. Thanks for taking the questions. A couple of questions for me just on the commercial portfolio. So obviously it was encouraging to see the recovery across L unit and Salanda.

Adam McCarter [Equity Research Associate Director: Hi there. Yeah, thanks for taking the questions. A couple of questions from me just on the commercial portfolio. Obviously it was encouraging to see the recovery across ELUNATE and SULANDA. Just on ORPATHYS, you did highlight the opportunity for NRDL inclusion following the SACHI-based approval. I am just wondering how significant do you think that could be commercially? Do you expect that to be a key driver of a recovery in China sales, or is the more meaningful inflection point still the SANOVO readout and the opportunity to further broaden adoption? That is my first question.

Adam McCarter: Hi there. Yeah, thanks for taking the questions. A couple of questions from me just on the commercial portfolio. Obviously it was encouraging to see the recovery across ELUNATE and SULANDA. Just on ORPATHYS, you did highlight the opportunity for NRDL inclusion following the SACHI-based approval. I am just wondering how significant do you think that could be commercially? Do you expect that to be a key driver of a recovery in China sales, or is the more meaningful inflection point still the SANOVO readout and the opportunity to further broaden adoption? That is my first question.

Speaker #7: But just on our path, you did highlight the opportunity for NRDL inclusion following the SACCI-based approval. I'm just wondering how significant do you think that could be commercially?

Speaker #7: Do you expect that to be a key driver of a recovery in China sales? Or is the more meaningful inflection point still the synoval readout and the opportunity to further broaden adoption?

Speaker #7: That's my first question.

Speaker #1: George, yeah.

Johnny Cheng: George, you would like to answer that one?

George Yuan: Yeah. I think that such inclusion in the NRDL will significantly improve the growth potential for the brand. Because if we look at the data, if you look at the EGFR-resistant patients, there are quite significant amount of patients with MET amplification. So far, there's no other choice. The bispecific monoclonal antibody in China is not included in the NRDL from Johnson & Johnson. We still have a growth potential. Also, this combination will extend the TAGRISSO treatment duration as well, and as well as kind of levers for AstraZeneca to compete with other TKIs. That's why we believe that this is a strong growth potential. Having said that, also one of the hurdle is we still need a secondary biopsy, so there's a kind of adoption at practice in the medical side.

Speaker #4: I think the SACCI inclusion in the NRDL will significantly improve the growth potential for the brand and because this is if you if we look at the data, it is if you look at the EGF resistant patients, they are quite significant amount of patients with meta amplification.

Speaker #4: And so far, there's no other choice and the specific monoclonal antibody in China is not included in the NRDL from Johnson & Johnson. So we still have a gross potential.

Speaker #4: And also this combination will extend the tagrisso treatment duration as well and as well as kind of levels for osteogenetic to compare with other TKS.

Speaker #4: That's why we believe that this is a strong growth potential. Having said that, also the one of the hurdle is that we still need a secondary biopsy.

Speaker #4: So there's a kind of adoption at practice in the medical side.

Speaker #7: That's great. Thanks, Adam, much for clarifying. My second question, again, in the commercial side of things is for Zacla. Just wondering how we should think about the growth trajectory for US sales going forward.

Adam McCarter [Equity Research Associate Director: That's great. Thank you very much for clarifying. My second question, again, in the commercial side of things is for FRUZAQLA. Just wondering how we should think about the growth trajectory for US sales going forward. Should we now be thinking about a period of steadier growth, with ex-US markets becoming an increasingly more important contributor to incremental growth for the brand?

Adam McCarter: That's great. Thank you very much for clarifying. My second question, again, in the commercial side of things is for FRUZAQLA. Just wondering how we should think about the growth trajectory for US sales going forward. Should we now be thinking about a period of steadier growth, with ex-US markets becoming an increasingly more important contributor to incremental growth for the brand?

Speaker #7: Should we now be thinking about a period of steadier growth with ex-US markets becoming an increasingly more important contributor to incremental growth for the brand?

Speaker #1: Okay. Maybe I'll just comment on this one. I think for Zacla, for the last year or less, I think there was some Medicare impact in terms of the growth unit.

Johnny Cheng: Okay, maybe I'll just comment on this one. I think for FRUZAQLA, for the last year or less, I think there was some Medicare impact in terms of the growth to net. As you can see, the growth momentum is through the geographic expansion of the ex-US market in the H1, especially. We have looked at a 70% growth there. Also, I think one point to note is, although the geographic has expanded, but the NLD in those market is only 50% so far. We believe there will still be a lot of opportunity for ex-US. Earlier, we have also shared with all of you that from our information from Takeda, that they expect US size, basically, the size of US peak sales versus the rest of the world will be kind of a 50/50 ratio.

Speaker #1: But as you can see, the growth momentum is through the geographic expansion of the ex-US market in the first half, especially. We have looked at 70% growth there.

Speaker #1: And also, I think one point to note is although the geographic has expanded, but the NRDL in those markets is only 50% so far.

Speaker #1: So we believe they will still be a lot of opportunity for ex-US. Earlier, we have also shared that with all of you that from our information from Takeda that they expect US side, basically the size of US pig sales versus the rest of the world will be kind of a 50-50 ratio.

Speaker #1: So we believe there's still a lot of growth momentum behind this global sales of Fuseca.

Johnny Cheng: We believe there's still a lot of growth momentum behind this global sales of FRUZAQLA.

Speaker #7: Great. Great. Thank you, Nathik. A chance maybe a final question just obviously reiterate the guidance. And could you just help us try and understand the key drivers that determine whether the business lands towards the lower the upper end of the range and other words, should we primarily be thinking about the contribution from milestones continued recovery of the China portfolio or ongoing growth in ex-China for Zacla revenues?

Adam McCarter [Equity Research Associate Director: Great. Thank you. If I could chance maybe a final question, just on, obviously, you reiterate the guidance. Could you just help us try and understand the key drivers that determine whether the business lands towards the lower or the upper end of the range? In other words, should we primarily be thinking about the contribution from milestones, continued recovery of the China portfolio, or ongoing growth in ex-China for FRUZAQLA revenues? Thank you.

Adam McCarter: Great. Thank you. If I could chance maybe a final question, just on, obviously, you reiterate the guidance. Could you just help us try and understand the key drivers that determine whether the business lands towards the lower or the upper end of the range? In other words, should we primarily be thinking about the contribution from milestones, continued recovery of the China portfolio, or ongoing growth in ex-China for FRUZAQLA revenues? Thank you.

Speaker #7: Thank you.

Speaker #1: Yeah. Well, I think, as you can see, that in the first half, the guidance for this year is actually $330 million to $450 million.

Johnny Cheng: Well, I think, as you can look that in H1, the guidance for this year is actually $330 million to $450 million. With our baseline achievement, it is without any business development contribution in there. We would be at least beating the lower end of the guidance. With certain potential partnering, which will recognize some up-front income that we can reach higher or even exceeding the high end of the guidance. That is the range. Also other factor that can affect H2 is, as we mentioned, FRUZAQLA, that we do anticipate that it will reach another level of sales milestone that will contribute, again, some one-time commercial milestone income that would also help us to meeting or even exceeding our target that we have given out to the market.

Speaker #1: So with our base line achievement, it is without any business development contribution in there, we would be at least beating the lower end of the guidance.

Speaker #1: But with certain potential partnering, which we will recognize some upfront ont income, that we can reach higher or even exceeding the high end of the guidance.

Speaker #1: So that is the range. But also other factor that can affect the second half is, as we mentioned, Fuseca, that we do anticipate that it will reach the another level of sales milestone.

Speaker #1: That will contribute again some one-time commercial milestone income that would also help us to meeting or even exceeding our target that we have given out to the market.

Speaker #1: So we are quite confident that we will be able to achieve this guidance that we have given out to the market earlier.

Johnny Cheng: We are quite confident that we will be able to achieve this guidance that we have given out to the market earlier.

Speaker #7: Great. Thank you very much for answering my questions.

Adam McCarter [Equity Research Associate Director: Great. Thank you very much for answering my questions.

Adam McCarter: Great. Thank you very much for answering my questions.

Speaker #3: Thank you, Adam. Just to repeat the instruction, if you have any question, do press the raise hand button at the bottom of your screen.

David Ng: Thank you, Adam. Just to repeat the instruction, if you have any question, do press the Raise Hand button at the bottom of your screen. The next question comes from Julie Simmonds of Panmure.

Operator: Thank you, Adam. Just to repeat the instruction, if you have any question, do press the Raise Hand button at the bottom of your screen. The next question comes from Julie Simmonds of Panmure.

Speaker #3: The next question comes from Julie Simmons of Pamir.

Speaker #5: Thank you for taking the question. Thank you.

Julie Simmonds: Thank you for taking the question. Thank you.

David Ng: Thank you.

Speaker #3: Thank you.

Speaker #5: Julie Simmons from Pamir Librum. Just again on the milestones, there was a milestone in the first half from Takeda. I was just wondering what that related to.

Julie Simmonds: Julie Simmonds from Panmure Liberum. Just again, on the milestones. There was a milestone in the H1 from Takeda. I was just wondering what that related to. Beyond the sales milestone to which you just referred, are there any other milestones anticipated? I was wondering if there is anything due from Astra on the SAPPHIRE-NN trial readout.

Speaker #5: And then, beyond the sales milestones to which you just referred, are there any other milestones anticipated? I was wondering if there's anything due from Astra on the SAFFRON trial readout.

Speaker #1: No. Actually, in the first half, just to clarify, it was from the approval of the RCC Renew Cell Carcinoma. So it was from Eli Lilly.

Johnny Cheng: No. Actually, in the H1, just to clarify, it was from the approval of the RCC renal cell carcinoma, so it was from Eli Lilly. Yeah. In terms of our H2, besides the sales milestone, so far, we do not expect any other milestones from our partners yet. In terms of if we achieve good results for our savolitinib, we will be receiving milestones more likely next year, not this year.

Speaker #1: And yeah. So in terms of our second half, besides the sales milestone, so far we do not expect any other milestones from our partners yet.

Speaker #1: But in terms of if we achieve good results for our supplement, we will be receiving milestones more likely next year, not this year.

Speaker #5: Lovely. Thank you very much. And then just as far as sort of the overall margins are concerned, you've done slightly better, I think, probably in terms of sort of balance between sales and spending than maybe I thought you might do.

Julie Simmonds: Lovely. Thank you very much. Just as far as sort of overall margins are concerned. You've done slightly better, I think, probably in terms of balance between sales and spending than maybe I'd thought you might do. Is the aim to continue to try to continue to be broadly breakeven to slightly profitable going forwards in your thinking of how the business is going and using the cash in potential business development activities?

Speaker #5: Is the aim to continue to remain to try to continue to be broadly break even to slightly profitable going forwards in your sort of thinking of how the business is going and using the cash in potential business development activities?

Speaker #1: Yes, definitely. I think it is a strong commitment—it's a requirement by our Board that we will continue to be break-even, and that's a commitment that we made a couple of years back.

Johnny Cheng: Yes, definitely. I think it is a strong commitment, requirement by our board that we will continue to be breakeven. That's a commitment that we made a couple of years back.

Speaker #1: And this is a strong commitment from all our management team. So this is not going to be changing. And of course, we will balance with investment in area definitely that would drive growth and creating value for shareholders.

Johnny Cheng: This is a strong commitment from all our management team. This is not going to be changing. Of course, we will balance with investment in area definitely that would drive growth and creating value for the shareholders. That's why we're accelerating ATTC program. At the same time, of course, we are exploring business development opportunity with our partners so that we can basically creating, accelerating our ATTC innovation opportunity.

Speaker #1: So that's why we're accelerating the ATTC program. At the same time, of course, we are exploring business development opportunities with our partners so that we can basically accelerate our ATTC innovation opportunities.

Speaker #5: Lovely. Thank you.

Julie Simmonds: Lovely. Thank you.

Speaker #3: Thank you, Julie. Again, if there's any question, please do press the raise hand button. At this moment, I don't see any further question online.

David Ng: Thank you, Julie. Again, if there's any question, please do press the Raise Hand button. At this moment, I don't see any further question online. Johnny, would you like to make a concluding remark?

Operator: Thank you, Julie. Again, if there's any question, please do press the Raise Hand button. At this moment, I don't see any further question online. Johnny, would you like to make a concluding remark?

Speaker #3: Johnny, would you like to make a concluding remark?

Speaker #1: Yes. I think thank you everyone for joining this interim results. And we look forward to meeting again, I think, in later on. We will be planning for a R&D day sometime later this year.

Johnny Cheng: Yes. Thank you, everyone, for joining this interim results and we look forward to meeting again. I think in later on we will be planning for a R&D day sometime later this year. We will make relevant announcement in due course. Thank you.

Speaker #1: And we will make relevant announcement in due course. Thank you.

Speaker #3: Thank you everyone. And this concludes our interim result presentation. Thank you. Bye-bye.

David Ng: Thank you, everyone, and this conclude our interim result presentation. Thank you. Bye-bye.

Operator: Thank you, everyone, and this conclude our interim result presentation. Thank you. Bye-bye.

Speaker #1: Bye-bye.

Johnny Cheng: Bye-bye.

Paul Choi: Goodbye

Lorenso Chiu: Goodbye

Q2 2026 HUTCHMED (China) Ltd Earnings Call

Request DemoDemo

HUTCHMED

Earnings