Innovent Biologics, Inc. (4502) Earnings Call Transcript & Summary
October 22, 2025
Earnings Call Speaker Segments
Zhengwei Song
executiveOkay. So good evening, and good morning, dear investors and analysts. So thank you all for joining Innovent Investor call today. Earlier today, we just announced a significant global strategic collaborations with Takeda. So we are hosting this call to share details and to discuss the strategic importance with us. So before we begin, I'm very honored to introduce a special guest from our partner Dr. P.K. Morrow, the Head of Oncology Therapeutic Area Unit of Takeda, who will join us for the discussion later on. So I will brief you today's agenda as follows. So Dr. Michael Yu, the Founder, Chairman of the Board and CEO of Innovent, will open with an update on Innovent's Globalization Strategy. Follow that, our CBO, Dr. Samuel Zhang, will then review the partnership arrangement and introduce Takeda as our partner. And after that, Dr. Hui Zhou, the Chief R&D Officer for Oncology pipeline of Innovent will present the details on the programs in the collaboration. So we will follow the presentation with a Q&A session, during which Dr. P.K. Morrow will also join the discussion. So with that, I will invite Dr. Yu to begin, please.
De-Chao Yu
executiveExcellent. Thank you, Wendy. Good morning, and good evening to each one of you. And welcome to joining our conference call tonight today. And I'm thrilled to announce our strategic partnership with Takeda, which will focus on the global development of our next-generation and oncology assets. Before we dive into the detail of the partnership, I just want to give you a brief introduction to Innovent's mission and goals, which described in this first slide, which is Slide 3. And at the beginning of our second decade, as some of you know that Innovent was found in 2011. So at 2021 the end of our first decade, we at our strategic meeting, we set a clear goal for the second decade which by the end of 2030, the company want to become a global premier biopharma. That was the goal we set for the company. The key to achieve that strategic goal is they actually need a 2 key pillars. The number one, we needed to develop a global competitive products, which will address unmet medical needs worldwide not only in China. Number two, to build a world-class global organization. Such an organization will have expertise and a capability in global development, regulatory filing as well as commercialization. So those are the 2 key pillars, we believe, will enable us to achieve our strategic goals. Next slide, Slide 4. In terms of the product, which is, we believe, the first pillar to achieve our strategic goal is to build a robust pipeline. As you may know that Innovent has been focused on 4 disease areas from oncology, immunology, CVM and ophthalmology. So in the last couple of years, we have been very productive from our own labs. In this slide, to give you a few examples from different stage of development from IND-enabling study to Phase I and II, to pivotal MRCT trials. We have over 10 assets, which potentially could become the product, meet the criteria we described earlier.So the goal to achieve our strategic goal is to -- as we shared with you earlier, is at least we can to have 5 assets going to be in MRCT Phase III studies. That's our first pillar. The second pillar, which is described in Slide 5, related to global development capabilities. Currently, we have about 100 people in U.S. cover from wet lab discovery research to development, including medical operations, regulatory as well as the -- some of the early development talents. And this team, we have achieved a few very significant milestones including the approval of IND for pivotal trial for one of the product we couldn't not talk about today which is IBI363. And our goal is to develop further growth team, develop the capabilities to meet the strategic goal we described earlier. Next slide, which is Slide 6. When I look back for the last 14 years, Innovent has been heavily depends on the partnership or collaboration arrangement with a variety of companies globally. For example, in 2015, we entered a partnership with Eli Lilly. And since 2015, we expand 6x now with Lilly from oncology to beyond the oncologic disease areas. We strongly believe the partnership we're entering today with Takeda will do the same to the growth of our business. The partnership not only give us the opportunity to work the best company in the world at the same time, an opportunity to us to learn from our partners in terms of how to develop and scale up the capabilities we are targeted to have. So by leveraging the both parties expertise in each collaboration, we have been able to advance the key tasks we found more efficient, more effectively than we could through internal efforts alone. Next slide, Slide 7. So today, we are very thrilled to announce a landmark strategic partnership with Takeda for the global development of our next-generation IO and ADC assets. This collaboration we consider as a transformative. The two parties, we share the same vision, and we feel that Takeda is the best fit for what we try to do in many aspects. Co-development and co-commercialization partnership for one of the products will allow us to work and learn with our partner every step of the way to grow our global capabilities and potentially become a truly global biopharma. For our collaboration assets, both IBI363 and IB1343, the two parties had a thorough discussion on the future development plan. And both parties are committed and confident that our combined efforts will maximize the value of those assets and will significantly enhance the growth of our company in the future. So this is just a very brief introduction about the announcement we made today. So next, I would like to hand over to Sam, our Chief Business Officer, to introduce to you the deal in detail and our partner. Sam, please.
Samuel Suhua Zhang
executiveThank you, Dr. Yu. It's my great pleasure to be here today. We are very excited about this global strategic partnership with Takeda. And this is not only China's largest -- next slide, please, largest strategic collaboration. For the first time, a China-based biotech strike a co-development, co-commercialization deal with more than $1 billion in upfront. Furthermore, the total deal value ranked #2 among all biopharmaceutical global partnerships. On the Merck Daiichi partnership, 3 well-differentiated late-stage ADC assets had more deal value. Not only that, this deal is going to create long-term value because of the co-development, co-commercialization structure on IBI363, our next-generation IO foundation therapy. This is not just bring financial value to the company, but also help us to build strategic capabilities as Dr. Yu just laid out for our globalization effort. We were very, very careful about picking the right partner. And when we were looking for the right partner, obviously, there is a basic requirement for the capability and resources. And we also feel that share the strong conviction of our assets is particularly important. We have a strong belief in our IBI363 as a transformational next-generation IO therapy because it is 2 magnet action -- both of the 2 magnet action are IO-based and therefore, are very well differentiated. As you may know very well, the IO mechanism of action has a potential to bring real difference to patients' life, extend survival and potentially have really bring transformational change to patients' life. And therefore, when we are looking for a partner, we're also looking for partner who have a strong conviction and strong belief and has a really strong strategic fit of IBI363 can really help their organization in a dramatic way. And last but not certainly not the least, we're looking for a true collaboration, a team spirit. And then we find Takeda. Takeda is a truly global company. It has more than $30 billion in annual sales and 52% of that coming from the U.S. When you combine U.S. and Europe, in total, it has more than 75% total revenue. The company had business over 80 different countries and has employees in 24 different countries. And in total, they have 50,000 employees around the globe. It has a very strong capability. More importantly, as soon as the 2 companies start to work together, we find very strong chemistry and the team has a very -- just worked together so well from beginning to now and to the future. Furthermore, we feel that Takeda is a great model that has really turned Asia regional player into a global powerhouse and therefore, have a lot for us to learn. And therefore, we think Takeda can be a really ideal partner for us in this journey to really help us to achieve success in globalization effort. As Dr. Yu mentioned, particularly Takeda, their commitment to this partnership really coming from the leadership level, and this really distinguishes Takeda. Next slide. Not only Takeda has overall very strong capability from global R&D perspective, as you can see, it also has a very strong footprint across geographic regions. Cambridge, Massachusetts is their U.S. headquarter and also U.S. R&D center that we have visited many times. And certainly, Dr. Morrow can comment more on that. And 45,000 across different countries, really strong development capability in North America, in Europe and Japan. In particular, the oncology leadership, next slide. Dr. Teresa is a very strong leader from a commercial perspective, and Dr. Morrow is a very strong clinical leader. And Teresa actually led the nivolumab global launch in the U.S. As many of you know, in the beginning, nivolumab really was a very -- nivolumab launch was one of the most successful global launch. It was able to achieve $3 billion, $4 billion per year sales in just over 2 years. And all those are under leadership of Teresa. So with Teresa as a leader of Takeda's Global Oncology business unit President, we feel very confident that IBI363 global commercialization is going to be really successful. And Dr. Morrow is a very strong R&D leader who was a professor at MD Anderson, I mean the top-notch cancer center in the world and also spent many years at Amgen, where many clinical research leader from the industry came from. And before he -- she took the head of R&D Head for Oncology at Takeda, she was also a Chief Medical Officer at CRISPR Therapeutics. So with Teresa and Dr. Morrow leading Takeda Oncology from business side and clinical development side, we feel very confident that our assets are in really good hand and can maximize its benefit to patients and realize commercial value. And in particular, in IBI363 in the codevelopment, co-commercialization model, we can also work hand-in-hand with Takeda to really develop our global development capability and also U.S. commercialization capability. Next slide. So just to give you a little more color about the strategic partnership. As Dr. Yu mentioned, it involves 3 different assets. IBI363 is a PD-1 IL-2 bispecific, which has clinical validated across 1,200 patients and has demonstrated superior efficacy over the existing PD-1 and in particular, in large unmet medical need, non-small cell lung cancer and also the so-called immune cold tumor MSS CRC. And both has a really high unmet medical need in two different ways. In non-small cell lung cancer, once patient receive the standard of care, let's say, PD-1 chemo, really, there's not much -- there's no immunotherapy that can work really well. And IBI363 as a single agent has offered a robust clinical activity demonstrated so far. And Dr. Hui is going to comment more on that. And that also shows the great potential to move into first line as well. And in microsatellite stable CRC, so-called immune cold tumors, the current standard of care PD-1 therapy just don't work at all, basically 0% response rate. As a single agent, IBI363 has double-digit response rate, clearly demonstrate clinical proof of concept. And both Takeda and Innovent has a strong commitment to really move this quickly through clinical development, not only in this particular indication, but also explore in other potential uses. For this particular assets, we have a global co-development 40/60 cost share and in the U.S., profit and loss share. And this, we believe, is going to enable a long-term financial return, but more importantly, strategic capability development in this as we are going hand-in-hand with Takeda. Ex-U.S., ex-China, Innovent is going to receive sales royalty up to high teens. And during the development stage, we also receive potential development and sales milestone as well. For IBI343, this is out-licensing deal, and we also feel Takeda is very well positioned to maximize the potential value of these assets and the GI targeted as the main indication of IBI343, we think Takeda is particularly well equipped to maximize, it is global development as well as commercialization. And for this asset, Innovent is to receive potential milestone and also to receive sales royalty up to high teens. And the third asset is the option of ex-China right. This is our first-in-class EGFR B7-H3 ADC. Once Takeda decided to exercise option, Innovent is going to be receiving option exercise fee and a milestone payment and sales royalty. So this is the high-level review of the key terms and the deal structure. Next, I'm going to ask Dr. Zhou Hui, our Chief R&D Officer for Oncology to go into more details of these assets.
Hui Zhou
executiveYes. Thank you, Sam. So as Dr. Yu and Sam mentioned that -- so today, we are really exciting to announce this strategic deal with Takeda. Actually, during almost last 1 year, we had deep discussion with Takeda's team, both are exciting about 2 assets scientific data and indication opportunity. We have fully aligned on 2 molecules future clinical development plan. And also, we are looking forward to collaborate together. So next. So IBI363, I think you may already familiar with this molecule. We believe this is -- we call the next-generation IO. And as you know, so this molecule designed with Alpha bias, so global first in class. Till now, we almost dosed over 1,200 patients, and we already have the melanoma study, the first registration study in China and also the global level, the IO-resistant squamous non-small cell lung cancer global study, we already approved from FDA and prepare for the initiation. And also for the third-line CRC also, we plan to initiate in China first. And also, we have more ongoing and other broader cancer population, we call the POC study. And also, we already have received multiple FTD or BTD from different agency. So next is our summary about the data for IBI363. So you can see that have strong immune activation and so across different tumor types, different indication, especially for the IO resistant squamous or non-squamous non-small cell lung cancer and also the melanoma patients and also the late-line MSS colorectal cancer. So here in summary actually, the key is from our ASCO presentation, so from different angle and to show the significant of improvement from the treatment of IBI363. And next is about our -- in our mind that IBI363 have a broader coverage, although we began from the IO resistant population and cold tumor population, but we still believe that this molecule could also cover IO-naive population. So that means we believe that cover even that means all-comers and across the different indications. And now as we shared with you in the past that the first wave, we focus on monotherapy in late line. And now we're also moving to the second wave. So the first-line non-small cell lung cancer, the first-line CRC and also, we are planning for more proof-of-concept study in other first-line indications and also including the neoadjuvant, adjuvant setting and in combination with our ADC, for example, now we have the IBI343 and 301 and also have a collaboration with our Takeda for the further global development. So as we discussed, so both parties actually fully aligned that on the overall clinical development plan, especially that for us that we believe the first-line lung and first-line CRC is the most important indication. We would like to maximize the value of IBI363 in both indications. Okay. Next, so 343, as we also shared with you that for this molecule, we believe that also differentiation molecule design, especially we have Fc-silent and site-specific the glycan conjugation. So this enables this molecule have the better safety profile that especially improved in terms of GI safety profile. So that means for us, it also could be, again, in combo with other potential treatment and also because of such kind of stable linker payload, we have a few hematology toxicity. So we can combo with other chemo again. And because of high potency payload so -- and also combined with the overall the molecule profile that we show the differentiation of the data for the PDAC population. So in total till now, we have over 340 patients dosed in gastric, PDAC and other tumor types. And we have the ongoing MRCT study in gastric cancer. And also this year, we announced that we initiated the Phase III study in third-line PDAC in China. We also received multiple FTD and BTD from the different agency. So next, about the key summary for the data. So for the gastric cancer, we published our data in Nature Medicine. So we also already have the oral presentation for the PDAC part, especially we believe that our molecule that potentially improved the PFS and OS in such highly unmet medical need disease. So we are also really exciting about this data. Okay. Next, for the key focus of 343, I think that based on CLND18.2 expression level, gastric cancer and the PDAC is our key indications. So for us, actually, we also aligned with our partner, Takeda, that the first-line gastric cancer and first-line PDAC is our key focus for the next -- we will support our partner for further the clinical development in both indications. And for the third molecule, which is the option in potential the right from our partner, so 3001, this is a global first EGFR/B7H3. And also, we shared with you that for this molecule that share the same linker payload platform and because of wide coverage of expression level of EGFR and B7H3, we believe that this molecule could target a lot of different tumor types. But for us, that actually we focus on the tumor types with B7H3 expression level first and also we will consider the EGFR expression level. So we identified that, for example, the esophageal cancer and also the head and neck and also PDAC as well, but also widely the potential for the non-small cell lung cancer. And also, we already saw the encouraging signal from ongoing Phase I study in U.S., in Australia and China. So we will update with you about the clinical data in the future academic conference. So in conclusion that we believe that the collaboration -- this collaboration will fully unlock greater value of our pipeline by combination 2 parties strength and efforts. This is also important for Innovent to for our global operation by a deep co-co partnership with Takeda. Two parties will benefit from this partnership and Innovent will maximize our long-term value, including financial returns, global influence and industry credibility. Thank you.
Zhengwei Song
executiveOkay. Thank you. Dr. Hui. So with that, we conclude the presentation part, and we will now open up for questions on the line. So I think the first question go to Ziyi Chen from Goldman Sachs.
Ziyi Chen
analystBasically, it's two questions. We do have the curiosity to understand the views from both Innovent and Takeda about the deal. For Innovent, what do you eventually make you feel this collaboration with Takeda is the best fit to Innovent's globalization road map. I think this has been a milestone deal for Innovent. This is the first major one for the core assets going into global. So what could potentially be the synergy? And why do you choose to do a co-development? I think this question could potentially address to Michael and Sam. And also for Dr. Morrow from Takeda, we're also trying to get a view from you that why did Takeda choose Innovent as a partner? And particularly, if we look at Takeda's portfolio in the past few years, oncology now currently about 12% of the sales. And there are 4 business segments in terms of revenue contribution is larger than oncology. So how should we see the strategy position of the oncology within Takeda? And how does Takeda see its oncology business in 5 to 10 years? And particularly, how would IBI363 and IBI343 fit into the strategy? Because we feel like Takeda do have a very strong presence in gastrointestinal cancers, including colorectal cancers, but what about lung cancer? I try to understand a bit more on that.
De-Chao Yu
executiveGreat. Thank you, Ziyi, for the question. So I will take the first one and ask Dr. Morrow for the second question. Why Takeda? As Sam and in his introduction about our partner, you probably already hear that lots of numbers and with all the credential credibility about that Takeda has built in the last over 200 years. Takeda, as you know, is a great company with a long history, probably one of the longest history in our pharma industry, over 240 years. So now become the leading biopharma in the world in several disease areas. We strongly believe based on all the facts and what we learned during the interaction over a year now with our Takeda colleagues, not only we see that Takeda has a development capability, commercial capability and the team and all the talent individual we have interaction with. As an example, Dr. Morrow, you're going to talk -- she's going to answer your question. And all the professional, we have a lot of respect and mind from us. Of course, Takeda has resources. So those, I think, the facts that help Innovent help me made the decision. We feel that Takeda is the best company can help us to maximize the value of the assets in both in IBI363 and 343. And at the same time, we feel that Takeda also is the best company who can help Innovent in achieving our strategic goals. And I remember that in several our annual strategy meeting, Takeda has been a showcase for us. When we talk about globalization, Takeda always is our best examples. We would like from regional company go to global and the step they took. And I believe they have learned lots of -- and accumulated lots of experience, which Innovent can learn from. And at the same time, as you may know that when we're asking for co-development and co-commercialization for a company like Innovent, and most of -- many companies we're interacting with, they may have a hesitation. So I'm very grateful to Takeda from the CEO to all the individual colleagues we have interaction with. They give us the opportunity to leverage what they have and help Innovent to achieve our globalization strategic goals. So those are I believe that besides additional to the fact that we talk about is the -- make us feel that Takeda will be the best -- is the best company as a partner for the partnership we have selected. So we strongly believe that with the -- all the vision we shared that the capability they have, the partnership will be a very productive. And all the key assets we have in the partnership will be have -- we're going to maximize the value through the collaboration and in the years to come. So those are the two major aspects we consider when we form a partnership with Takeda.
Phuong Morrow
executiveThank you, Michael. And maybe I can add from the Takeda standpoint, we really are honored to work with Innovent. We believe that Innovent is a strong strategic, scientific and clinical partner for Takeda. And specifically, as you asked, IBI343 and IBI363 align directly with our prioritized strategic modalities, which have been ADCs, biologics and small molecules. So they are among those -- 2 of those 3. And the prioritized tumor areas, which include GI and thoracic tumors also are well aligned and truly fit hand in glove with the Takeda oncology strategy, which, as you know, has also been based upon success with therapies such as fruquintinib as well as brigatinib. So we are delighted to partner with Innovent. This is truly, we believe, an accomplished team with very deep expertise in next-generation immuno-oncology as well as understanding ADC biology. When you asked about the oncology portfolio, I would note that this really helps us to further balance our pipeline across heme cancers for which we're very well known and now with more solid tumor indications potentially. IBI343 and 363 are both important investigational medicines for our oncology pipeline and also for the broader Takeda pipeline. And we're really encouraged by the ability for these therapies, having dosed so many patients and having such encouraging data to address significant unmet need near term as well as for the future.
Zhengwei Song
executiveThen we will take the second question. So the next question goes to Dr. Huang Yang from JPMorgan.
Yang Huang
analystThis is Yang from JPMorgan. So I have two quick questions, one for Innovent management and one for Dr. Morrow. Maybe first one for Dr. Morrow. So from a scientific and clinical standpoint of view, what does Takeda or you think as a key advantage and the market opportunity for IBI363 and IBI343?
Phuong Morrow
executiveThank you so much. I would note specifically that these 2 therapies, and I'll start with IBI363, which is truly an IO-IO therapy, combining both IL-2 alpha bias as well as PD-1 mechanism of action in a novel way to potentially be very effective in both the second line as well as in the frontline settings in lung cancer and in other tumors. So we are very encouraged by the data that Innovent has shared with us, and we believe that it has potential to really help patients with thoracic cancers and in immune deserts such as MSS CRC as well as other potential life cycle management indications. For 343, the novel platform as well as the widened therapeutic index with very encouraging and durable efficacy, tolerability as well as the ability to be dosed and combined to become part of potential other frontline therapies for gastric cancer and pancreatic cancer are very encouraging to us also. I would not note the market, but I would say that we're very encouraged by the ability to reach as many patients with clinical unmet need as possible. Thank you.
Yang Huang
analystYes. My second question is for Innovent team. So I know a little bit more about your global development plan because you already started 1 global Phase trial, right, in second line squamous non-small cell lung cancer. So can you give us some more color on what additional global Phase III or late-stage trial you might consider to start or initiate in the next few months or years? And what could be potential development cost for 363?.
De-Chao Yu
executiveOkay. Hui, you may...
Hui Zhou
executiveOkay. Thank you for your question. So yes, as you know, we already announced that the first global MRCT IO squamous non-small cell lung cancer approved and plan to initiate. And also, as we shared with you that now we have a really good discussion and align on the overall clinical development plan with Takeda. And for the further global clinical development plan, so actually, we have a lot of discussions. And also, as Dr. Morrow said that we will focus on the lung cancer and CRC and for the time line or the details about such kind of plan, so actually, we will work with Takeda and then to share with you more about the future update. So thank you. So cost... okay.
Yang Huang
analystYes. Can you quickly comment on potential development costs? How much Innovent might have to spend to develop globally for 363 in the next few years?
Phuong Morrow
executiveYes. Thank you, Dr. Huang. Maybe I can give overall color on the overall development budget. You may be interested to ask. So I think, first of all, the two parties have conducted in-depth and detailed discussions and reached alignment on the overall clinical development plan for both IBI363 and IBI343. The target indications and the related budgets for both programs have been clearly defined. And secondly, we will use the POC plus MRCT model to balance the risk and reward of the investment. The MRCT will be initiated with the supportive data from POC. And thirdly, if we think about the financial position of Innovent, we actually have more than USD 2 billion in cash on hand. This strong financial position will primarily support the company's pipeline development and global expansion. Innovent's China business continues to demonstrate strong growth potential and improved profitability, providing the group with a very stable and sustainable positive operating cash flow. So based on the development plan, time lines of IBI363 and 343, Innovent's financial strength is expected to be sufficient to support the joint global development efforts. Thank you, Dr. Huang.
Zhengwei Song
executiveOkay. So the next question goes to Chen Chen from UBS.
Chen Chen
analystFirst of all, congratulations on your landmark deal with Takeda. It's really exciting to see that 363 find a best fit. Well, following this question, can management and Dr. Morrow, please help us understand how can the two parties leverage the perspective strength to fully unlock the value of these assets. For instance, how will Innovent's R&D experience and expertise in IO and also ADC support this collaboration? And Dr. Yu just now has highlighted Takeda's global experience, network and capabilities. Well, can management please also elaborate a bit more on well, in what way will Takeda's experience and capabilities contribute to the R&D and commercialization of these two assets?
De-Chao Yu
executiveGreat. Thank you. Maybe we'll go with Dr. Morrow first and then Dr. Hui.
Phuong Morrow
executiveThank you, Michael. So we at Takeda are very energized by the progress that Innovent has made to date, and we really look forward to the ability to collaborate in lockstep in order to, as you allude to, truly unlock the potential of these programs for which we find extremely encouraging data and great promise. So drawing from our shared deep experience in oncology, Innovent IO technology as well as expertise and the fact that the modalities that are leveraged by 363 and 343 are areas of our shared expertise. We feel that the two of us as partners are uniquely positioned to partner to accelerate and expand the potential of both of these agents in a range of solid tumors. And specifically, when I deep dive into those two elements specifically, for 363 as a next-gen IO-IO therapy, it has the potential to be highly effective in second line and earlier lines of therapy as well as in immune cold and IO-resistant tumors, giving an ability to demonstrate significant monotherapy as well as in combination in a multitude of solid tumors. And for 343, this next-generation ADC gives us great confidence in the ability for it to meet critical unmet need. And we believe that our partnership and leveraging not only the operational efficiencies across the two companies, but also our broad opinion leader network and engagements will help to continue to accelerate both enrollment as well as completion of these trials and moving them hopefully towards a potential future multiple approvals.
Hui Zhou
executiveThank you, Dr. Morrow. So about Innovent part, so especially our expertise in IO and ADC. So as you know, so for IO, we have the backbone sintilimab and post-sintilimab, actually, we also have several other bispecific or different IO assets. So actually, for us, we learned a lot from sintilimab and other IO assets, especially through the clinical development and molecule design. So those actually help us to build up the foundation to currently what we already see from IBI363, actually, this really help for us for the overall development of IBI363. And for ADC in last 5 years, actually, we already built up 3 different platforms, 2 is single payload platform and the third is dual payload platform and over almost 20 assets. So we also have actually from ADC part, we already built up our such kind of clinical development capability. And for Innovent, I think, as you know, so our unique opportunity is that for China part, so especially for the efficiency, the clinical data generation. So we can continue to leverage such kind of advantage to generate the POC quickly, high quality and to support further global clinical development and leverage the expertise of Takeda in the global level experience and to work together to maximize the value of both assets. Thank you.
Zhengwei Song
executiveThank you. As we have almost -- the call has run almost for an hour, I think maybe we can just have one last question before we end. I think the last question goes to Wangbin Zhou from Citi.
Wangbin Zhou
analystCongratulations on the remarkable collaboration. So maybe I have two quick questions. The first to Dr. Zhou on the following catalysts for the IBI363. So given we are doing the Phase II POC studies for the first-line non-small cell lung cancer and CRC and also a global Phase II U.S. trial. So when do we -- when can we have some more data for these trials? And also a quick question for Dr. Morrow. So to follow the 363 plus ADC. So currently, the IO plus ADC is a new trend and 363 should be a new cornerstone product in the IO space. So how do we maximize the potential of this product and our future combination strategies. And we know that we have the option for the EGFR/B7H3 is the right? So could you give us more color on this?
Hui Zhou
executiveThank you. For the first question. So as we shared with you in the past that we believe IO resistant population and IO naive population are different population. So that means although we generate a lot of data already in IO-resistant population as a monotherapy, but we believe that we cannot just copy the dose level from the later line population. So that means for move to the first line, we still need to generate the safety line and also the dose optimization study and further potential the proof-of-concept data. So that's why we are still have such kind of ongoing study in first-line CRC and first-line non-small cell lung cancer. And so now we collaborate with our partner, Takeda. So for the overall publication plan and the future, so what the timing of the -- which conference we will disclose. So we will work together with our Takeda team and then to have overall publication plan, and we will share with you in the future investor call or through IR. Thank you. So I think then Dr. Morrow for the second question.
Phuong Morrow
executiveThank you. And along -- in answer to your question, we agree both companies have strong scientific and clinical conviction around not just the data, but also the scientific mechanism of action of 363. We've discussed in great depth, and we're fully aligned on the development plan, which reflects truly the shared conviction in both the biology as well as the ability for it to meet unmet need. If I could divide it into 3 areas in which we have the greatest focus, one, of course, is ensuring that we are effective and are developing in indications in which patients have progressed or developed resistance to frontline or earlier lines of IO. Second, the ability to be used in combination, potentially even in a novel, novel mechanism or others in earlier lines of therapy or as monotherapy. And thirdly, to be effective in potential immune deserts or in cold tumors in which IO therapies have not been effective. We've discussed this in great depth with Innovent, and we believe that we are fully aligned on hoping and working to maximize the potential of 363.
Zhengwei Song
executiveThank you. Now we are approaching the end of our scheduled time. So let's wrap up today's call. Again, thank you all for your valuable time and the questions during today's investor call. So we hope today's discussion has helped you again get a clear understanding of the strategic value of our global collaboration with Takeda as well as the potential of our joint IO and ADC programs to global cancer treatment. And also a special thank you to Dr. P.K. Morrow from Takeda for joining us and sharing your valuable perspectives. This partnership truly embodies the power of global collaboration in the biopharmaceutical industry, I believe. So for any follow-up questions, please feel free to reach out to our Investor Relations teams. And once again, thank you for your ongoing support of Innovent Biologics. So with that, we will conclude today's call. Thank you.
Phuong Morrow
executiveThank you.
De-Chao Yu
executiveThank you.
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