HUTCHMED (China) - Earnings Call - H1 2025

Transcript

Speaker 2

Hello everyone, this is David Ng, Head of Investor Relations of HUTCHMED. Thank you for joining HUTCHMED's 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. Just a quick moment on the disclaimer. 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, 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. Weiguo Su, our CFO, Johnny Cheng, our CMO, Dr. Michael 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, but please make sure you have your name and your company name on the screen. Now, let us welcome our Chief Executive Officer and Chief Scientific Officer, Dr. Weiguo Su, to begin our presentation. Dr. Su?

Speaker 6

Thank you, David. I forgot the next slide. Again, good evening, good morning, everyone. Welcome to the HUTCHMED mid-year result conference call. The highlights for the first half of 2025: Global commercial success for ZECLA continues to grow, first half, up 25% compared to 2024. Savolitinib, potentially our second global commercial product. There are filings ongoing based on SAVANNA in some countries, and obviously, the global registration study, SEFRON study, is recruiting. We anticipate completion of recruitment later this year. LNH 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 three first-line, non-small cell lung cancer, osimertinib plus savolitinib study called SENOVO, should complete enrollment very, very soon. If anything, I think we are already fully enrolled. SEFRON, as I mentioned, should also complete recruitment shortly.

Surufatinib, phase two-three study in first-line pancreatic cancer, phase two readout, and phase three transition is progressing. FGFR4 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. FRUQUENTINIB, RCC, as I mentioned, NDA filed early this year, and within the next 12 months, we expect approval. The SEFRON study, the phase three readout should be sometime first half 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.

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

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, which includes proceeds from the partial divestment of our joint venture with Shanghai Pharmaceuticals Holding Co., Ltd. So 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 $18 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 seven, our P&L. Overall, the revenue for the first half of 2025 was $278 million, down 10% versus the same time last year. Investments in R&D amounted to $72 million, reflecting multiple NDA submissions under review in China.

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 Holding Co., Ltd. Moving on to the next page, we have adjusted down our full-year revenue guidance to between $270 million to $350 million, mainly to reflect a revision for the phasing of certain clinical and commercial milestones, and also the delay of savoplanib commercial launch. I will now pass to our Head of Commercial, George Yuan, to share with us on the commercial performance.

Speaker 6

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

The China CRC market becomes very competitive in the later line. We see more REGORAFENIB generics and the TAS102 generics launched in the past 12 months. Also, there's an uptake of the combo regimen in the third line. BEVA combo cross-line treatment becomes more popular than before, and we face a final push by the REGORAFENIB before the VVP. We adjust our market strategy, and we gain back some of the share on the Q2 last 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. The EMC launch, as well as the future RCC approval, will further drive our growth. Next slide. This year, the MAT market went through a strong turbulence with additional four NRDL-listed products starting from the year beginning, with all of the four 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 of first-line, as well as the SACHI approval before the middle of this year. ORPATHYS has been well positioned for this year's NRDL renegotiation. Of course, SACHI is certainly the key differentiator versus other TKIs. We will strongly leverage AstraZeneca's expertise in the 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 NAT market, we also have some kind of headwinds. We see the octreotide generics launched in the market. Also, we saw this year SULANDA gained to the NRDL, and the 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, 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 the SULANDA in the NET treatment. The diagnosis and the know-how of the treatment for the NET is still growing, and we believe there's a lot of educational opportunity as a leader in the TKI segment. We will further drive the category. Next, I will hand over to Michael.

Speaker 4

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, FRUQUENTINIB is also expanding into the new indication in China, such as endometrial cancer and RCC. Our other 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 surufatinib is in the late phase two development with the late phase readout later this year. Our first heme product has metastasized and has been approved in China, with additional new indication development in the follicular lymphoma. Later on, I'll also give you an update on our first SYK inhibitor in savoplanib for NDA and also the WIHA development. Our third wave product, rinocetinib and fenergatinib, are also at a pivotal registration trial stage.

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 clinical development. First, 760 is our third-generation BTK inhibitor, currently still in the phase two development in the refractory DLBCL. Our new MET inhibitor, 506, also entered clinical development. It's in the dose escalation stage in the AML. Today I'm going to give you an update on some of our new class of agents. Dr. Su mentioned the ATTC, Antibody Targeted Therapy Conjugate product. Three early pipelines, A251, 580, and the 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. Now we're actually making pretty advanced progress in our first three molecules, and all targeting enters clinical pretty soon.

I think the ATTC has several key differentiations 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. Through the linker optimization, we really overcome some of these physicochemical properties of small molecules as a payload. By doing that, it could have a better efficacy through antibody and small molecule combination while targeting specific mutations can overcome drug resistance and potentially support a combination with other target therapies, particularly in the front-line setting. It also improves the safety given the low target, on-target, and off-tumor toxicity than the small molecule. Unlike other toxin-based ADC, it has less myelosuppression and also has a better quality of life. It also has a favorable pharmacokinetic profile resulting from antibody-guided delivery to the target sites, improved the bioavailability, and reduced drug-drug interaction compared to oral small molecule TKI. Next slide.

Mechanistically, the ATTC can target proteins required for cancer growth. It has a synergistic effect with a combination with functional antibodies and also has the ability to combine with other chemo target therapies or standard of care chemotherapy, which is particularly important in the front-line setting. There are numerous reports that the chemo-based ADC is working less effectively with the tumors with dry remediation. This will have the opportunity to really establish a better therapeutic window through the reduction of on-target and all-tumor toxicity. It has other less other compound-induced toxicities such as liver QT, lung QT, et cetera. It can be dosed long-term with the improved safety window and with a reduced systemic toxicity for small molecules. More generally, the ATTC platform can also be expanded to incorporate high molecular weight drug payload. This is actually a platform to have multiple opportunities. Next slide.

This is the design of our first ATTC candidate, A251. On the antibody side, it uses clinically proven, well-established humanized IgG1 antibody, and with a small molecule payload with a drug-to-antibody ratio of four. For the proof of concept of this platform, the antigen we selected is expressed in multiple tumor types, and the antibody is internalized favorably. On the payload side, it really leverages our small molecule expertise and with a highly potent against kinase family with border 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 effects to kill the antigen-negative cells. On the linker side, it is pretty stable in the plasma, and it will be cleaved by the proteins highly expressed in the cancer cells, so it has a very precise target delivery in the tumor cells. Next slide.

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 for tumor cell lines with high antigen expression. In the middle figure, it shows the bystander effect. For antigen-expressed tumor cells, it has pretty good tumor killing, but for low or no expressed antigen, the A251 has no anti-tumor activity. If you co-culture the antigen-positive and negative cells, it actually has the activity to kill both the negative and the positive cells. It really demonstrates the bystander effect. It also preserves the ADCC activity, same as the nickel antigen antibody shown on the right-hand figure here. Next slide. This is a proof of concept, 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 one antibody shown in green and the small molecule payload shown in red here with a biweekly dosing, and it shows tumor growth inhibition. The single dose of target one and ADTC shows robust anti-tumor activity compared with the antibody alone or the small molecule payload alone or the combination of both payload and the antibody. This is a very important proof of concept showing a single dose ADTC delivers sustained tumor inhibition over a 14-day period of time and shows good tolerability. On the right-hand side, we can see the payload itself or payload plus antibody, although it has an anti-tumor effect, also reduces the body weight. The A251 itself, dosed at 30 milligrams per kilogram, has no weight loss. It is very important to show not only induced tumor regression but also a very good safety profile. Next slide.

The A251 also shows very good synergistic activity with the standard of chemotherapy. The left panel here is the tumor xenograft model. The combo with chemo shows a synergistic effect. On the right-hand side, we have seen the tumor cell line study also shows 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 ADC, toxin-based ADC, cannot actually combine with the standard of care because of the toxicity. Okay, next slide. I'm going to highlight some of the progress on our key asset, Savolitinib. Both in the global and the China development are really going to drive the future growth. At the ELCC 2025, we have reported the data, AZ reported the data for the Savanna study and showing the durable response overall response rate.

In the same conference, we also showed our Savolitinib in MET exon 14 skipping non-small cell lung cancer, also showed a very good response rate and also the sustained overall survival. This also leads to our approval, not only getting a full approval for late-line MET exon 14 non-small cell lung cancer indication, but also expanded the first-line indication. Very importantly, George also mentioned our second-line EGFR TKI refractory patients, Savolitinib plus osimertinib in MET amplified patients. This one, we achieved the 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 SENOVO first-line trial, and we're planning on trying to finish the SHIFRON trial recruitment this year. The gastric cancer in MET amplified patients also is 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 OC plus Savolitinib, which has a ratio of 0.34, and the PFS improvement versus chemo from 4.5 to 8.2 months. Also, regardless of the first, second generation TKI treatment or prior third-line TKI progress, the patient has a ratio that is very consistent. In particular, for third-generation TKI refractory patients, as you can see, the controlled chemo arm only had a PFS of three months, and the Savolitinib plus OC reached the PFS of almost seven months.

Also, the response rate, disease control rate, and durability of response have been extended by OC plus Savolitinib combination. Next slide. Interestingly, we also observed the publication for amivantamab in the MARIPOSA-2 trial, as you recall, the amivantamab plus chemo versus chemo trial. They also have a biomarker subgroup analysis. MET amplified patients only identified about 14% of the patients in the MARIPOSA II trial. Unlike our study for SACHI, we observed about 30% of the MET amplification by FISH analysis. In the patient population, as you can see, the chemo RNA actually both trials, the MARIPOSA II and the SACHI trial, are very consistent. Remember, these patients have MET amplification progressed on the prior third-generation TKI, and amivantamab trial showing the PFS of 3.1 months, but their improvement is only to 4.4 months PFS with a hazard risk of 0.51.

The patient population, in this population, what we can conclude, just like the SACHI, MET amplified patients have a very poor prognosis. Their PFS is only three months. The SAVOLITINIB plus OC reached the PFS almost seven months with a hazard risk of 0.32. This is quite a significant difference. We believe in the biomarker selected patient population, SAVO plus OC really demonstrates superior activity, really addressing these patients with a poor prognosis. Also, both the Savanna and the SACHI trial demonstrate the combo has a very effective effect in the patient with the baseline brain metastases. These are the key differences between the OC plus SAVO compared with other studies 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. Next slide.

The SACHI approval, I also want to mention, that enables us to go through the NRDL negotiation this year. We presented our SAVOLITINIB medicine 14 trial at the ELCC. We have observed very substantial improvement of OS. The patients with the prior treated patients with the OS of 25 months, and the patient with the front-line setting, the treatment naive patients, the OS with the long follow-up have an OS with 28 months, and the upper limit has still not been reached. Among all the MET TKI, the SAVOLITINIB actually demonstrates the longest overall survival repeated so far. We're very excited about this data. Next slide. Also, FRUQUENTINIB has been extending into the other indications. We already got early approval for the endometrial trial. We have the overall response rate of 35%, and also the median PFS reached 9.5 months.

We are also going to present our phase three FRUZAQLA II trial at the upcoming ESMO later this year and showcase the activity that's been chosen as a meaningful oral presentation. We will highlight the data. The NDA has already been accepted and is under review at the NMPA. Next slide. Our first hematological product with metastasis also got 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 IRC overall response rate of 63.6%. The index here assessed the ORR with 68%. It is very consistent with the global trial leading to the approval in the U.S. and Japan. Next slide. Surufatinib is our combination study in pancreatic cancer. It is going very well. Pancreatic cancer is a highly deadly disease.

It has a five-year survival rate of less than 13%. In general, the PDAC is a cold tumor, immune cold tumor, and not responsive very well with immune therapy. From our preclinical work and the IT study, we actually demonstrated that surufatinib as a VEGF inhibitor not only inhibited the VEGF FGFR pathway, but the CS1R inhibitor pathway also has an immune modulating function. This is a phase two, three trial currently ongoing in combination of camrelizumab PD-1 and chemotherapy for the treatment-naive PDAC. At the ASCO 2025, the investigator-initiated trial also showed this surufatinib plus camrelizumab with chemotherapy in the first line, demonstrated overall 51% versus 24% of the chemo. There is also a significant improvement of the PFS. The phase two portion of the trial is going to read out later this year.

If the results are good, it will trigger the decision-making to the phase three portion of the trial. Next slide. I am going to give you an update about the ESMO-1 study. We presented the data at the EHA last year, demonstrated robust overall response rate of 71% and the durable response 48%. Because the dual mechanism not only inhibited the macrophage digestion but also stimulated and inhibited B-cell production. This dual mechanism of SYK inhibition really provides advantage, particularly in patients who are refractory to TPO-TFRA treatments. During the review course, as you recall, we submitted NDA, and the NMPA stipulated there is a lower impurity limit. This requires further CMC validation and stability tests. We target resubmitting with the additional data in the first half of next year, 2026, and with additional rolling data, it will be the later part of next year.

Here's the update of our savoplanib in the ITP NDA status. Next slide. We also have another trial with warm autoimmune hemolytic anemia, the phase 3 trial. We have shown previously that savoplanib reached the overall response rate of 66% and the durable response 77% because WIHA is a very deadly disease, and no targeted therapy has been approved. It represents a high MMI need. We are very excited that the phase 3 registration trial has already completed recruitment with the data readout next year. I think we make very strong progress in the R&D, and we're really hoping our R&D team with our novel Antibody Targeted Therapy Conjugate (ATTC) platform will develop new treatment modalities for the new development, and our late-stage product line will advance and propel for future growth. With that, I'll turn to Dr. Su.

Speaker 6

Thank you, Mike. And also thank all speakers for the update. Before we get onto the Q&A, I just want to highlight and give you a sum up. In the first half of 2025, we completed SHPL partial divestment with a proceeding of over $600 million. We also worked on two major products, Savolitinib and FRUQUENTINIB, in an effort to expand their indications. 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. This combination, 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.

This combination, by precisely targeting the two 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 SENOVO study, as well as the global phase three study in second-line EGFR-mutant non-small cell lung cancer called SHIFRON 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 Mike 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 INFINZI. FRUQUENTINIB, we obtained approval in second-line endometrial cancer earlier this year, and we filed for RCC. These additional indications will continue to drive the commercial performance of FRUQUENTINIB in China.

Outside China, FRUZAQLA continues to grow, delivered 25% growth in the first half. We expect launches of this innovative product in other countries around the world in the 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 products or 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, with more to follow. Longer term, if ATTCs reach clinical proof of concept, as demonstrated in the preclinical setting, we expect these ATTCs to position us for the long-term future growth.

These programs will have the 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, 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, and thank you very much. I think we are now open for questions. David, you want.

Speaker 4

Thank you, Dr. Su. We are now open for questions. 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 CLSA? Matthew, your line is now unmuted. Go ahead.

Okay. Thanks, David and Dr. Su, for taking my questions. I've got three questions. First is regarding our very exciting ATTC platform. I wonder, am I right that we will likely see what drug targets it is in the second half this year? Firstly, regarding A251, and also the development strategy. It seems that, am I right, that you will go directly to the front line as combo chemo standard of care, right? This is the 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 effects of the change of the sales team and marketing strategy. Can you get more elaboration on this? This is my second question. The third question is regarding the SYK inhibitor, savoplanib.

My original expectation is to have finished the stability test by the end of this year and received NDA approval. What's the new message from CDE regarding this new change of a new submission required next year? That's all. Thank you.

Speaker 6

Okay. Thank you very much, Matthew, for your questions. I briefly touched on your questions, and maybe Mike can chime in later. Regarding ATTC targets, the plan is to, for A251, which IND submission is expected in September, 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. You will see, you will have all the information, all the preclinical development, all preclinical data at EORTC. Development strategy, clearly, I think they have, these molecules are very different from chemos. They'll have a very different chemo or toxin-based ADCs. They will have very different safety profiles. 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.

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 are our payload targets, or high overexpression and so forth. 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, 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 transition certainly has some impact, but 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. There is a practice change in the field or in hospitals.

There is certainly much less or much more careful off-label usage prescribed by the doctors. That certainly will shrink the off-label contribution to the total sales. The 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, the first quarter was bottomed out, and the second quarter started to grow. We are pretty much back to where we would expect in June and July. We are very optimistic in the second half, the momentum will continue and will perform to our expectations. We believe that the sales decline in China is transitory, and we are already seeing recovery. We are quite optimistic about the second half. Your last question about SIG. It went through a lot of discussion.

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 qualify 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. Recent communication with CDE guided us to focus on CMC. Now we are full speed ahead in the CMC area where we have to complete the PPQ batches and accumulate the stability data. We expect to have the data available for initial submission March or April next year, with additional or longer-term stability data to be rolled in since the program is under breakthrough therapy designation in China. That is where things are.

I know we are all disappointed by the delay, but at least now we have clarity. We can drive with our activities. I also want to mention 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 the U.S. FDA was okay with the level of the impurity and allowed us to proceed, we felt we wanted to explore ways to sort this out. I think the issues in China forced us to look into other ways. We potentially have a strategy to go forward in the U.S. with a new chemical entity with full patent life. It would make a lot of sense to switch the molecule outside China completely and with a much longer LOE for the product. Potentially, it could be a very short development timeline because of the known target.

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 is a great target for these indications. It is probably the best in ITP and WIHA we have done so far, and it could be potentially useful for other indications as well. With regard to ATTC and SIG, maybe Mike, if you have anything to chime in.

Speaker 4

Yeah. Thanks, Dr. Su. I just want to mention that for the clinical development side, I think we're very excited about this A251 development. What we're trying to do is really the global development simultaneously with the U.S.-China development to really not only leverage our synergy but also take advantage of some of the regulatory approach, particularly in the United States. The FDA is really kind of encouraged through this Project Frontrunner, right? You can actually start a combination in the 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 frontline combination earlier. That will be the key for our development strategy.

We think also, right, you talk about the target, and we are planning to close at the future scientific conference later this year. I think the most important, like I mentioned, our antibody part selection is a well-known target and has a well-established drug in the clinic. The payload is really the innovation part. 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 reached, this will be a very robust platform for a lot of new generation molecules to come. I don't think I have too much to add on the SYK inhibitor part. Thank you.

Speaker 5

Thank you, Dr. Shi. Thank you, Dr. Su. Next question is from Chen Chen of UBS. Chen Boshe, 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.

Hi, can you hear me now?

Yes.

Okay. Hi. Good evening. 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 second half recovery. I want to maybe just ask how you're thinking about potential economic sensitivity here affecting end demand for oncology products in the China market and just 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 what potential timeframe you're thinking about there. That would be helpful. Thank you very much.

Speaker 6

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 team, the whole 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 on-label CRC, we actually saw growth over the first half of last year for FRUQUENTINIB, as well as for SULANDA in neuroendocrine tumors. I think that what we need to, I think George's team has now sorted out the marketing strategy, and it seems it's working. I think we just need to adapt. The team needs to adapt to the marketing-driven strategy and help physicians understand our products and also to help patients, obviously. I obviously expressed optimism for the second half.

That's built on the strong performance or strong recovery of these products in China in the past three months. It's been challenging. We just want to be transparent. We are seeing good momentum at the moment. I believe that the momentum will continue in the second half. 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 second quarter next year. Hopefully in the clinic before end of second quarter. Most important is that this is going to be a, we believe it's going to be a very rapid clinical development. Mike sometime will be able to share with all of you.

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 to clinic, go into clinic, hopefully we have a partner to either co-develop or out-license. Yeah.

Speaker 4

Okay. Great. Thank you.

Speaker 6

Thank you.

Speaker 5

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

Speaker 1

Thank you. Can you hear me now?

Speaker 5

Yes, yes. Thank you.

Speaker 1

That's good. Thanks to management for taking my 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 FRUQUENTINIB sales in the U.S.? My second question is for your Savolitinib. When can we expect its NDA submission in third-line gastric cancer in China? Also, for your ESAH2, will you consider NRDL negotiation or commercial insurance drug list this year? Thanks.

Speaker 6

Okay. Thank you for the questions. Tariffs, to be honest, we don't have any idea. Given the exporting or the manufacturing cost for FRUQUENTINIB 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 something to pay the tariffs. I think, 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. ESAH2 product, Tezvaric, of course, we are preparing for NRDL discussion later this year. Obviously, this is a very different product. At the moment, it's a still imported drug. The cost is higher.

The patient population it serves, the first indication we got approved for is third-line follicular lymphoma, which is a relatively rare form of lymphoma. Overall, I think we have a lot to talk about when we go up to the, when we engage with NRDL. That's our plan at the moment. Thank you.

Speaker 1

That's very clear. Thank you.

Speaker 5

Thank you, Chen Chen. Thank you, Dr. Weiguo Su. Sorry, we ran over time a little bit. I noticed there may be some questions still outstanding. Please 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. Weiguo Su, Dr. Michael Shi, Johnny Cheng, and George Yuan for attending the call. That's all for the call. Thank you.

Speaker 6

Thank you.

Speaker 4

Thank you all.