HUTCHMED (China) Ltd (HCM) 2025 Q2 法說會逐字稿

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  • David Ng - Head, Investor Relations & Capital Strategies

  • Hello, everyone. This is David Ng, Head of Investor Relation 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 operation of HUTCHMED Group contained within this presentation are historical in nature, and past performance is no guarantee of future results, and actual results may vary materially from those set forth in the forward-looking statement.

  • So today, we are very glad to have our CEO, Dr. Su; our CFO, Mr. CHENG; our CMO, Dr. SHI; and our Head of Commercial, Mr. Yuan, to go over the results and provide the latest update on our performance and the projects and the development.

  • As usual, we will have a Q&A session at the very end. When you can press the raise head 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.

  • So now let us welcome our Chief Executive Officer and Chief Scientific Officer, Dr. Weiguo Su to begin our presentation. Dr. Su?

  • Weiguo Su - Chief Executive Officer, Chief Scientific Officer & Executive Director

  • Thank you, David.

  • If we go to the next slide. So again, Good evening, good morning, everyone. Welcome to the HUTCHMED mid year results conference call. The highlights for the first half, 2025, global commercial success for FRUZAQLA continues to grow first half, up 25% comparing to 2024.

  • ORPATHYS or savolitinib, potentially our second global commercial product, there are filings ongoing based on savannah in some countries and also obviously the global registrational study, Saffron study, is recruiting. We anticipate completion of recruitment later this year.

  • And of course, ELUNATE in China new indications, endometrial cancer approved early this year and RCC already filed as well. We do have a lot going on. We expect in the next 12 months our Phase III first line, non-small cell lung cancer, osimertinib plus savolitinib study called SANOVO should complete the enrollment very, very soon.

  • If anything, I think we already fully enrolled. SAFFRON, as I mentioned, should also complete recruitment shortly. SURUFATINIB Phase II/III study in first line pancreatic cancer, Phase II readout, and the Phase III transition is progressing.

  • FGFR4 inhibitor NDA submission is in preparation. Plan to file this later this year and the SAVOLITINIB SAMETA study for PRCC globally and gastric cancer in China. NDA submissions are also planned. For [quintin] RCC, as I mentioned, NDA filed earlier this year and within the next one month, we expect approval.

  • The saffron study, of course, the Phase III 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.

  • And we are also exploring BD activities for not only our ATTC programs, but other programs as well. Without further ado, I'll just send it over to the next speaker, our CFO, Johnny Cheng to give you a financial overview and update.

  • Johnny?

  • Johnny Cheng - Chief Financial Officer & Executive Director

  • Thank you, Dr. Su.

  • On page 6, we can see our balance sheet reflects a very strong cash position. Over $1.3 billion in cash resources, which includes proceeds from the partial divestments of our joint venture with Shanghai farm. So these resources will allow us to accelerate global ATTC development and explore potential investment opportunities.

  • Further down the balance sheet, under no other non-current liabilities, we have deferred approximately $18 million of divestment gains as a provision for profit guarantee to the buyers. This will be recognized over the guarantee period, subject to the joint ventures performance in the next few years.

  • Turning over to page 7. Our P&L. So overall, the revenue for the first half of 2025 was $278 million, down 10% versus same time last year. Investment in R&D amounted to $72 million reflecting multiple NDAs 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 farm.

  • 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 facing of certain clinical and commercial milestones and also the delay of so commercial launch.

  • I will now pass to our Head of Commercial, George, to share with us on the commercial performance.

  • George Yuan - Executive Vice President & Head, Commercial

  • Thanks, Johnny and the first half year of our commercial results is relatively flat. So [Zacla] posted a very strong growth, 25%, but offset by a weaker China performance in for three brands, ELUNATE, SULANDA, and ORPATHYS.

  • That slide, if we look at the FAA, we know that CRC is the third most common cancer and also the second leading cancer for the fatality worldwide and with a new country adding to the launch market and also include the reimbursement, we see for ZAA deliver a very strong solid growth in the first half year.

  • Especially Japan with Tata's strength in and the know-how in the CRC mark as well as the benefit and the value of SAA in CRC being highly recognized by nice recommendation. So these products will continue to gain market share and through the expansion of the reimbursement and the new launch countries.

  • Next slides. The China CRC market become very competitive in the later land. We see more refined generics in the past one or two generics launched in the past 12 months. Also there's an uptake of the combo regime in the sirin.

  • Beva combo become crossline treatment become more popular than before and also we face a final push by the rein before the BDP. And so we adjust our market strategy and we came back some of the share on the Q2 last this year and we still believe we are the strong market leader in the Surland CRC and we will continue to be the market leader in the CRC and the EMC launch as well as the future RCC approval will further drive our growth.

  • Next slides. The year, the TKI the map market went through a strong turbulence with additional four RL listed the products starting from the year beginning with all of the four with the first slide indication. OA is actually lost the market share in the beginning of the year, but through the middle of this year, we get a full approval first one as well as the such approval before the middle of this year.

  • Oasis has been well positioned for this year's NRD renegotiation. Of course, such is certainly the key differentiator versus others TKIs. Also we will strongly leverage the AstraZeneca's expertise in the lung cancer.

  • The combo treatment will be the first and the best oral due precision medicine to offer to the lung cancer patients.

  • Next slides. If we look at the net market, we also have some kind of headwinds. We see the octa real ide the generics launched in the market. Also we saw this year Leno. Tied again to the NRL 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 short term hiccup for our business, but If we look at the future, we still believe we are the market leader in the TAS segment, and we have an obligation to gain the market share for the whole segment as well as the surrender in the net treatment.

  • The diagnosis and the know-how, the treatment is 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 hang over our Ming Shi.

  • Ming Shi - Executive Vice President, Head, Research & Development & Chief Medical Officer

  • Yeah, thank you, George. I'm going to give you an update about our pipeline. So we have made tremendous progress in our late stage product development in addition to the global approval of the CRC for Quan also expanding into the new indication in China, such as endometrial cancer and RCC.

  • And our another brand Savaliin also achieved label expansion approval with multiple new indications in the late stage of the moment again with our partner, AstraZeneca. Dr. Su also mentioned Surfain it is in the late Phase 2 development with the late phase readout later this year.

  • And our first hen product has metastat has been approved in China, with additional new indication development in the follicular lymphoma. Later on, I will also give you an update on our SI inhibitor in subplanet for NDA and also the YA development.

  • And our third wave product reno and the ferrograinate also at a pivotal registration trial stage. All these products will profound our future growth. Next slide. And this slides also give you an update of our our early stage pipeline advancing or will be entered into the clinical development.

  • First, 760 is our third generation BDK inhibitor currently still in the Phase 2 development in the refractory DLBCL. And our new main inhibitor 506 also entered the clinical development is in those escalation stage in the AML.

  • Also today, I'm going to give you an update some of our new class of agent. Docto mentioned the ATTC and antibody target therapy conjugate product. Three early pipeline A251, 580, and the A30 will all enter clinical development later this year and also next year, nextli.

  • Here's our update about the ATTC platform. During the last conference call, with this disclose our new platform and so now we are actually making a pretty advanced product in our first three molecule and all targeting enter clinic pretty soon.

  • And so I think the ATTC have several key differentiation showing here because we really leverage and maximize the synergy between the the the target therapy and also our small molecule know-how as a as a as a payload.

  • And really through the linker optimization to really overcome some of these physical chemical property of small molecule as a pay and so by doing that it could have a better efficacy through antibody and small molecule combination while target specific mutation can overcome drug resistant and potentially support a combination with other target therapy, particularly in the frontline setting.

  • And also improve the safety given the low target on target and off tumor toxicity than the small molecule. And also unlike other toxin-based ADC, it has less mild suppression and also have a better quality of life. And also have a federal pharma kinetic profile resulting from antibody guided delivery to the target sites, improve the viability and reduce drug drug interaction compared to all small molecule TKI.

  • Next slide. So mechanistically, the ATTC can target protein required for cancer growth. It has a synergistic effect with a combination with functional antibody and also has the ability to combine with other chemo target therapy or center of care, chemotherapy.

  • And which is particularly important in the frontline slighting and also there are numerous reports the chemo based ADC is working less effectively with the tumors with dryer. So this will have the opportunity to really establish a better therapeutic window and through the reduction on target and the tumor toxicity and also, it have other less other compound induced toxicity such as liver QT, lung QT, et cetera.

  • So it can be those long term with improve the safety window and with a reduced the systemic toxicity of a small molecule and more generally that the ATTC platform can also be expanded to incorporate high molecular weight drop payload.

  • So this is actually is a platform to have multiple opportunity next slide.

  • So this is the design of our first ATTC candidate 8,251. So on the antibody slide is use a clinically proven, well established humanized and IgG1 antibody and with a small molecule payload, with a drop to antibody ratio of 4.

  • For the proof of concept of this platform and the antigen we selected is expressed in multiple tumor type and the antibodies is internalized favor and on the palo side, it really leverage our small molecule expertise and with a highly potent, against kine family with broader genetic alteration and has the potential to synergize with the antibodies to overcome resistance and improve the efficacy.

  • We also show you some of the bystander effect to kill the energy negative cells and also on the linker side, it has a pretty stable in the plasma and it will, you will be cleared by the pros highly expressed in the cancer cells.

  • So have a very precise target delivery in the tumor cells. Next slide. And this slide shows some of the preclinical data for 82, 51 in a panel of the tumor cells. We actually see a very potent activity with a subno molar range of IC 50 for tumor cell lines with a high energy expression.

  • And in the middle figure, it shows the bystander effect for energy expressed tumor cells it has the pretty good the tumor killing but low or no express antigen right the the 82, 51 has no anti-tumor activity but if you co-culture the energy positive and negative cells, it actually have activity to kill both the negative and the positive cells.

  • So it really demonstrate the bystander effect and also it preserve the ADCC activity is the same as the naked antigen antibodies showing on the right hand figure here.

  • Next slide and this is a proof of concept preclinical proof of concept for our 82, 51. The target antibody is linked to a target therapy payload with a special linker, and the left figure show here is the target one antibody showing green and the small molecule, payload with the showing red here with a biweekly dosing and it shows a tumor growth inhibition.

  • And also the single dose of target one and ADDC shows the robust and the tumor activity compared with the antibody alone or the small molecule payload alone or the combination of both payload and antibody. So this is very important proof of concept showing a single dose of ATTC deliver a sustained tumor inhibition over 14 day period of time.

  • And show good tolerability because on the right hand side, we can see the payload itself or pay lo plus antibody, although have under tumor effect but they also reduce the body weight, but the 82/51 itself, those at the 30 mg per kilogram has no weight loss.

  • So it's very important to show not only induce that tumor regression, but also have a very good safety profile.

  • Next slide. And also the 82, 51 also show very good synergist activity with the standard of chemotherapy. The left panel here is a tumor enograph model. The combo with chemo show, a synergicity effect, and also on the right hand side, we have seen the tumor cell line study also showed that chemotherapy plus A251 have a synergist activity.

  • So this is quite different from the other toxin-based ADC because in the all the clinical development setting you can see. Most of the ADC, toxin-based ADC cannot actually combine with the standard of care because, the toxicity.

  • Okay. Next slide. Also I am going to highlight some of the progress on our, the key assets of internet and both in the global and the China development, really going to drive the future growth. So at the ELCC 2025, we have reported the data AC reported the data for Savannah study and showing the durable response overall response rate.

  • And in the same conference, we also show the our cyber in medicine 14 escaping non-small cell lung cancer also show a very good response rate and also the sustained the overall survival. So this also lead to our approval not only get a full approval for lali medicine 14, a non-sport cell lung cancer indication. But also expand the first line indication.

  • Very importantly, George also mentioned about our second line EGFR TKI refractory patients, opasis plus osimmergen in me amplify patient. This one we achieved the NMPA approval in the June and also, has been selected in ASCO presentation, during the annual ASCO meeting.

  • Doctor Su mentioned our PRCC, the Semida trial will also finish the also finish recruitment and the readout for for this trial will be early next year. And for the China side, we also achieved the recruitment for the Sanoval first line trial and also we are playing trying to finish the Saron trial recruitment this year. And the gastric cancer, in meta amplified patients also are preparing NDA for later this year.

  • Next slide. And this is also showing the key results for Sai trial and in the overall intend to treat patient population, the PFS OC soid which is a has a ratio of 0.34 and the PFS improvement versus chemo from 4.5 to 8.2 month. And also regardless the first second generation, TKI treatment or prior third line TKI progress the patient.

  • The haz ratio is very consistent and in particular for 3rd generation TKI refracture patient as you can see, the control chemoR have only have a PFS three months and the Savo plus OC reached the PFS almost seven months and also the response rate disease control rate and ability of response also has been extended by all all C+ subvo combination.

  • Next slide. And interestingly we also observed the the publication for Evan and in the M2 trial as you call it the Amiplus chemo versus chemo trial. They also have a biomarker subgroup analysis.

  • M5 patients only identify about 40% of the patients, in the Mariposa 2 trial. And unlike our our study for Sai, we observe about 50 30% of the me amplification by fish analysis and so in the patient population as you can see the chemo arm actually both trial the Maripos too and the Sachi trial are very consistent. And remember these patients have amplification progress on the prior third generation TKI and am trial showing that PFS of 3.1 months but their improvement is only to 4.4 months PFS with a hazard of 0.51. So, the patient population in this population, what we can conclude just like the Saatchi.

  • Me amplified patients have very poor prognosis. Their PFS only 3 months, but the sub limit plus O reached the PFS, almost 7 months, with a high rate of 0.32.

  • So this is quite significant difference. We believe in the biomarker selected patient population, Salvo plus OC really demonstrates superior activity, really addressing these patients with a poor prognosis. And also both the Savannah and Saatchi trial demonstrate the Congo has a very effective effect in the patient with the baseline brain brain metastasis.

  • So these are the key difference between the all C+avo compared with other study because this is the only biomarker selected patient population. And also with the only chemo-free regimen. So we believe this will have a very substantial usage in the in the clinical setting. Yeah, next slide.

  • And the Saatchi approval, I also want to mention that enable us to go through the NRD negotiation this year. And also present our subin medicine 14 trial at the ELCC and we have observed very substantial improvement of OS so the patients with the prior treated with patients.

  • As the OS 25 months and the patient with the frontline setting, the treatment IE patient, the OS with a long follow up have a OS with 28 months and the upper level SP will now be reached. So among all the med TKI. The salit actually demonstrate the longest over survival repeated and so far. So we are very excited about this data.

  • Next slide. And also for quininab has been extending into the other indication. So we already get the early approval for the mutual trial. We have the overpo rate of 35% and also the median PFS reached 9.5 months and we are also going to present our phase three.

  • Seek a 2 trial at upcoming ISO later this year and showcase the activity has been chosen as a meaningful oral presentation, so we will highlight the data and the NDA has already been accepted and under review at the MMPA.

  • Next slide.

  • Our first hematological product has metastat also get the third line for formal approval. It showed the high consistency with the global trial and, so at the EHA this year we showed the patient in the third line of follicular lymphoma with the RRC over response rate of 63.6. And the and the investigator assess the OR with 68%. So, it is very consistent with the global trial leading to the approval in the US and Japan.

  • Next slide.

  • Surfatinib, is, our combination study, in the pancreatic cancer is going very well. Pancreatic cancer is a highly deadly disease, have a 5 year survival rate of less than 13%.

  • In general, the PDAC is a tumor, immune cold tumor, and not responsive very well with the immune therapy. From our preclinical work and IT study, we actually demonstrate the, sin as avaja inhibitor, not only, inhibited the vaja FGFR pathway, but the 61R inhibitor pathway also has an immunomodulating function. So, this phase 23 trial currently ongoing.

  • Combination keralizumab, PD1 and the chemotherapy for the treatment of PDAC, so this will, at the AO 2025, the investigator initiative trial also show this sero plus paralizumab, with the A chemotherapy in the first line demonstrate that over 51% versus 24% of the chemo and also there is a significant improvement of the PFS. So the phase two portion of the trial is going to read out later this year. What will trigger if the result is good will trigger the decision making the phase three portion of the trial.

  • Nextli. Also I am going to give you an update about the EL one study. So we presented the data at the IHA last year that demonstrate the robot over response rate of 71% and the d response 48%. So because the dual mechanism, not only inhibited the macrophage digestion but also stimulating.

  • Inhibitor B cell production. So the dual mechanism of sick inhibition really provide advantage, particularly in patients who are refractory the TOTFRRA treatment. During the review course, as you recall, we submitted NDA and the MMPA stipulated as a lower impurity limit. So this requires further CMC validation and stability test.

  • So we target, resubmit with the additional data, in the first half, next year 2026, and with additional rolling data will be next, later part of the next year. So, here is the update of our sub planet in the ITP NDA status and next slide.

  • And we also have another trial with warm autoimmune hemolytic anemia, the phase three trial. We have shown previously that soplat reached the overall response rate of 66% and the durable response 47% because the Y is a very deadly disease and no target therapy has been approved so represent a high.

  • I need. So we are very excited that Phase III registration trial has already completed movement a recruitment and with the data right read out next year. So I think we make a very strong progress in the R&D and we are really hoping our R&D.

  • With our novel ATTC platform will develop new treatment modality for the new development and our late stage prop line will advance and propel for future growth and so with that I'll turn to Dr. Su.

  • Weiguo Su - Chief Executive Officer, Chief Scientific Officer & Executive Director

  • Thank you, Ming, and also thank all speakers for the update.

  • Before we get on to the Q&A, I just want to highlight, give you a A sum up So in the first half of 2025, we completed SHPL. Partial divestment with the proceeding of over $600 million. We also worked on two major products, Slettinib and through Quintinib.

  • In an effort to expand their indications, severalitinib, we obtained the Saatchi approval in second line EGFR mutant non-small cell lung cancer with mat amplification. We anticipate. Following the treatment with third generation EGFR TKI, about one-thirds of patients will develop resistance due to that amplification.

  • So this combination, the approval of this combination, sublitinib plus osmotinib offers a treatment potential for these patients, and that amplification, as we know, is a driver and patients, and these patients do very poorly on standard leukemmo and this combination by precisely.

  • Targeting the two drivers, EGFR mutation and map amplification. Demonstrate very strong clinical benefits. And also chemoree and additional trials are ongoing, including the first line, EGFR mutant on small cell lung cancer with met over expression in China called Sannova study as well as the global Phase III study in second line, EGFR mut mutant no small cell lung cancer called Saffron study.

  • So we look forward to data readout of these trials. We believe that activation play, 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 several lain in China in gastric cancer.

  • And we also expect the data to read out in the global PRCC study in a combination with the infinity. Frequent, We obtained approval in second line. Endometrial cancer early this year and we filed for RCC so these additional indications will continue to drive the commercial performance of entity in China.

  • Outside China, for ZEA continues to grow, deliver 25% growth in the first half and we expect launches of this innovative product in other countries around the world in coming months. So there are launches. These launches will continue to drive the growth of furzela outside China.

  • So midterm, strategically, we are exploring how we can leverage our cash to accelerate growth both in commercialization and potentially R&D portfolio as well. So looking for opportunities to acquire products or commercial products or pipeline. Candidates.

  • And of course, we are highly focused on our ATTC platforms, very, innovative globally first in class molecules. Really, I look forward to the first molecule initiating clinical trial later this year and with more to follow.

  • Longer term, we need to, if, ATTCs reach clinical proof of concept as demonstrated in, pre-clinical setting, we expect these ATTCs to, position as for the long term future growth, these programs will as we will have potential to be positioned in in early lines, particularly front lines in combination with chemos in combination with IOs and in combination with targeted therapies.

  • So we expect that these platforms will deliver multiple products in the future for us.

  • Next slide, I think this, 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.

  • David Ng - Head, Investor Relations & Capital Strategies

  • (Operator Instructions)

  • Matthew Yan, CLSA,

  • Matthew Yan - Analyst

  • Yeah, I've got three questions. First is regarding our very exciting ATTC platform. I wonder, is it, am I right that that we we were likely to see what drug targets it is in the second half this year, firstly, regarding A21. And also the development strategy it seems that am right that you go directly to the front line combo chemo standard of care, right?

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

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

  • So what's the new message from CDE regarding this new change of a new submission required next year.

  • Weiguo Su - Chief Executive Officer, Chief Scientific Officer & Executive Director

  • I briefly touch on your questions and maybe Mike can chow me later. So regarding ATTC targets, I'll the plan is to for A20 for A251, which IND submission 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.

  • So you will see you will have all the information, all the pre-clinical development of all clinical, pre-clinical data at the ERTC. Yeah, strategy, clearly, I think they have these molecules are very different from chemos. They'll have, are very different from chemo or toxin-based ADCs. They will have very different safety profile, and we expect that these molecules can be, will be able to be combined with.

  • A variety of therapies, as I mentioned, including, chemo, SOC or IO or even other targeted therapies. So, 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 payload targets or, high over expression and so forth.

  • So as a monotherapy, however, we all, but that might be a strategy for rapid, biomarkers selected pathway for for registration, but the much greater potential is in combination in first line in combination with the chemo chemo IO or even other targeted therapies, targeting all comers without even genetic alterations, and we will explain the rationale at the URTC conference.

  • So that's about ATTC sales decline, team transitioning certainly has some impact, but a lot more than that. As the anti-corruption trial, anti-corruption, anti-corruption activity has been going on in China for some time. So compliance is now becoming more and more important physicians are fully aware of compliance issues.

  • So they -- so there is a practice change in in the field or in hospitals. So there's certainly much less or much care much more careful off-label usage, prescribed by the doctors. And so that certainly will shrink the off-label contribution to the total sales.

  • So 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, first quarter was bottom out and the second quarter start to grow. We are pretty much back to where we would expect in June and July.

  • So we are very optimistic in the second half, the momentum will continue and well perform to our expectations. So we believe that the sales decline in China is it is transitory and we are already seeing recovery and we are quite optimistic about about the second half.

  • The last question was sick, so it, 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 to studies to qualify the level and additional CMC studies to bring it all the way down to a minimum or to blow the target or allow the target level.

  • So the activities went on in these two areas in parallel and recent communication with CDE, they, guided us to focus on CMC, and, now we are full speed ahead in the in the CMC area we have where we have to. Complete the PPQ batches, accumulate the stability data, but we expect to, have the data available for initial submission.

  • March or April next year, and with additional or longer term stability data to be rolled in since the program is under breakthrough therapy designation in China. So that's where things are I know it's, we are all disappointed of of the delay, but at least now we have clarity, we can drive with, our activities.

  • I also want to mention about potential outlicensing outside China. This program, as because of these issues, we pretty much stopped the outside China clinical development, even though USFDA was okay with the level of the impurity allowed us to proceed, but we felt.

  • We wanted to explore ways to sort this out, and I think this forced the issues in China forced us to look into other ways. So I think we are, we potentially have a strategy to go forward with in the US with a new chemical entity with the, with full patent life.

  • So I think it would make a lot of sense to to, switch the molecule outside China completely and, with a much longer LOE for the product, but potentially could be a very short development timeline because of the non-target, no, and, so I think outside China it could actually present a very attractive our licensing opportunity once we finish. Some clinical, of early clinical, development.

  • At least now we think it's a great target for for these indications. It's probably the best in ITP and why how we have done so far and it could be potentially useful for other indications as well. So I think that this, with regard to ATTC and SI, maybe Mike, if you have anything to charm in.

  • Ming Shi - Executive Vice President, Head, Research & Development & Chief Medical Officer

  • So I just want to mention that for the clinical development side, I think we are very excited about this 251 development and what we try to do is really the global development simultaneously with the US-China development because really not only leverage our synergy but also take advantage some of the regulatory approach, particularly in the United States, the FDA is really kind of, encouraged, for through this project front runner, right?

  • You can actually start the combination earlier line setting much sooner, compared with actually the CDE. So I think this is a part of the development strategy we are going to undertake even when we have the dose escalation defined the dose, we could actually move to the frontline combination, earlier.

  • So that will be the key for our development strategy and we think also right, you talk about the target and we we are planning to close at the future scientific conference later this year, but I think the most important like I mentioned.

  • Our antibodies part selection is a is a well-known target and have a well established drug in the clinic, but the payload is really the innovation part and we think our target therapy payload with the linker will be developed, really leverage our in-house small molecule expertise can really deliver a lot of potential first in class molecule, if this, if it is a clinical proof of concept is reached, this will be a very robust platform for a lot of new generation molecule to come. Yeah, so I don't think I have too much to add on the sick part the SYK inhibitor, yeah, so thank you.

  • David Ng - Head, Investor Relations & Capital Strategies

  • Paul Choi, Goldman Sachs.

  • Paul Choi - Analyst

  • Congratulations on the progress. I want to maybe just address the commercial side of it first, and Dr. Su, you talked about your confidence in the second half recovery, but I want to maybe just ask, how you're thinking about potential economic sensitivity here.

  • Affecting and demand, in your for oncology products in the China market and just sort of what your thoughts are on sensitivity to the economic broader economic situation and then following up on your comments on the sick inhibitor and and partnering, potentially for a next generation or or follow on molecule here, can you maybe just comment on, how what your timing you think could be for, initial, entry into the clinic there? I know that's contingent up upon a partner, but just sort of what your potential time frame you're thinking about there, that would be helpful.

  • Weiguo Su - Chief Executive Officer, Chief Scientific Officer & Executive Director

  • On the commercial, China commercial, as it's being a bit turbulent because of the anti-corruption and the compliance requirements and also for Hajjmat in particular, obviously the team the whole the commercial team has gone through a lot of changes as well.

  • Overall, I think the market remains there. Competition may be up as George pointed out, particularly in CRC. But if anything, actually the on label CRC we actually saw growth over last year, first half of last year for for quintinib, as well as for seofatinib in neuroendocrine tumors.

  • So I think that what we need to, I think George's teams now, Sorted out the marketing strategy and it it's working and and I think we just need to take, to Adapt, the team needs to adapt to the to the marketing driven strategy and help physicians understand our products and also to help patients.

  • So obviously, I think I obviously expressed optimism for the second half, and that's built on the strong performance or strong recovery of these products in China in the past three months. So it's been changing, we just want to be transparent, but we are seeing. Good momentum at the moment, and I believe that the moment that the momentum will continue, in the second half, the obviously is there.

  • On the sick, yeah, this is going to be a very interesting approach. I think, I hope we can talk more about it. It will be very rapid. I, we expect.

  • The new entity will be in clinic or I&D submission, maybe second quarter next year, so, hopefully, in the clinic, before, end of second quarter and most important Is that this is going to be a, we believe it's going to be a very rapid clinical development. My sometime we'll be able to share with all of you, and.

  • All clearly with the high probability of success, because this is this is a known target, and we have a lot of data to support, so the probability of success should be very high. So I think, yeah, by the time we are ready to go to clinic, go into clinic, hopefully we have a partner to to either code develop our license, yeah.

  • David Ng - Head, Investor Relations & Capital Strategies

  • Chen Chen.

  • Chen Chen - Analyst

  • My first question is on tariffs, and earlier this week, Trump said that farmer tariff is going to be imposed starting from small next week and then up to 250% ultimately. So can management please comment on the impact of your frequent lip sales in the US?

  • And my second question is, for your syn, when can we expect an NDA submission in third line gastric cancer in China and also for your EH2, will you consider like an RDL negotiation or commercial insurance drug list this year?

  • Weiguo Su - Chief Executive Officer, Chief Scientific Officer & Executive Director

  • Tariffs, to be honest, we don't have any idea, but given, the exporting, or the manufacturing cost for the native is is relatively low. So 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 have to pay the tariffs, but I think that the the personally, I think the impact won't be that much.

  • But until we actually understand the details, I think it's very difficult to to to estimate. Your second question on GC, for salitinib, a NDA filing is planned later this year, likely end of this year.

  • This is for for a late stage gastric cancer met amplification, ECH2 product tester of course, we are preparing for NRDO, discussion later this year and obviously, this is a very different product at the moment. It's a still imported drug.

  • The cost is higher, so and the patient population serves the first indication we got approved for is third line follicular cancer, a follicular lymphoma, which is a relatively rare form of lymphoma. So overall, I think we have a lot to talk about when we go up to the -- when we engage with the NRDL, but yeah, that's our plan at the moment.

  • David Ng - Head, Investor Relations & Capital Strategies

  • Sorry we went over time a little bit, but, and I noticed there may be some questions still outstanding, so do feel free to reach out to us and we will try to answer your questions maybe offline. So thank you, everyone for supporting us and listening to the call.

  • Thank you, Doctor Su, Doctor, Johnny and George for attending the call and that's all for the call.

  • Ming Shi - Executive Vice President, Head, Research & Development & Chief Medical Officer

  • Thank you.

  • Weiguo Su - Chief Executive Officer, Chief Scientific Officer & Executive Director

  • Thank you, all.