Operator
Thank you for joining Kelun-Biotech earnings call for 2025 annual results. Within next 1 hour, we are going to present our business and financial performance in 2025, followed by a Q&A session.
Management presentation will be conducted in Mandarin with English interpretation. Please switch to English channel if you prefer English language.
This conference call will be recorded and provided to Kelun-Biotech's clients or used internally for reference and distribution. Any forward-looking statements made during this call are based on current expectation and assumption made by the management.
The company undertakes no obligation to update or revise, unless required by laws or regulations. The unaudited information is just for reference only, and should not be considered as investment advice or guarantee of the future performance.
Ze Jian Zhou
OK, let me introduce you attendees on corporate side: President and CEO, Dr. Ge; Chief Strategy Officer, Mr.
Feng; Chief Scientific Officer for biologics, Dr. Tan; Chief Scientific Officer for small molecule, Dr.
Yu; Chief Medical Officer, Dr. Jing; Chief Commercial Officer, Mr.
Ding; Chief Officer for Distribution Management and Market Access, Mr. Cheng; VP of Small Molecule R&D, Dr.
Song; and myself, Chief Financial Officer, Mr. Zhou.
I'm going to pass on to the CEO, Mr. Ge, for the presentation.
Over to you, Mr. Ge.
Ge Junyou
Thank you. Dear investors, analysts, good evening, or good morning.
Thank you so much for taking the time for this call with Kelun-Biotech. The presentation will contain 4 parts.
I will start with myself covering the business overview and the business highlight in 2025. The second part will be covered by Mr.
Ding for the commercialization, and CMO will take you through the pipeline review. Then, finally, CFO, Mr.
Zhou, will cover the financial performance. Let me start with the first part.
Kelun-Biotech is a company that's dedicated to R&D, manufacturing, and commercialization of oncology, immunology, and metabolic diseases. The company very well.
The company has been established for over 10 years with real differentiation, our technical platform and pipeline. We are becoming a leader in the innovative drug industry of China.
The core of our R&D is the OptiDC, which is the antibody-conjugate, the technical platform. Also, Merck and Kelun Pharma are the 2 largest shareholders, and this reason we are getting the resources from the top players from China and the U.S.
to drive the company forward. We have over 30 R&D projects, including 4 products that have been launched in the market with 8 indications, 1 in NDA, and 10+ projects in clinical development stages.
We expect in 2026 this year, more products will be approved in China with more indications expanded. A company as of December 2025, as you can see, we have a headcount of over 2,000 people.
As you can see, the main changes is that we now have a commercialization team with nearly 600 people who are responsible for the marketing and sales promotion in China. Now I'm going to talk about the pipeline for the company.
As you can see, starting from the left, we have 4 launched products and 1 NDA. Among the launched products, the TROP2 ADC, we got our first indication in end of 2024 for triple-negative breast cancer in the late-line treatment.
Then, in 2025, we had several indications, which is including in the second-line, the third-line for EGFR-mutated non-small cell lung cancer, which is really the first TROP2 ADC approved for lung cancer worldwide. Also, we also have approval for second-line and above for the zero-positive, HER2-negative breast cancer.
Last year, the HER2 ADC, which is the trastuzumab botidotin, which was also approved in China October last year, making the first domestic ADC approved for HER2-positive breast cancer. Additionally, we have 2 more products, namely cetuximab for RAS wild-type colorectal cancer, monoclonal antibody ML1, as well as PD-L1 drug for nasopharyngeal cancer as a third-line, the first-line treatment approved last year and shown in the table on the right in addition to trastuzumab injection.
We have also 9 other ADC projects in different stages and new conjugate drugs, differentiated targets, and the design of linkers, and new drug payload structure, including our ADC for bispecific antibody SKB571, and the first radionuclide conjugate drug, SKB107, which entered clinical stages. At the same time, SKB575, which is really the first TSLP with bispecific with targets undisclosed, but is already in clinical stages.
This is the pipeline. Moving on, Kelun-Biotech value a lot on international collaboration, partnership, and cooperation.
This is really where the best way to promote our pipeline to the world market, achieving maximization of the value of the pipeline, the maximization value of the company. As last year, we been working with MSD, Libo Therapeutics, and Biotheus, and Crestline.
We signed multiple licensing-out agreements for cellular and genetic therapy. You can see our partners have started 17 global Phase 3 clinical trials, including 5 for lung cancer, 4 for breast cancer, 6 for gynecological oncology, 1 for gastric cancer, 1 for urinary oncology, covering all the way from second-line, third-line to first-line and even adjuvant and neoadjuvant therapy.
Last December, we partnered with Crestline for common commercialization efforts, including SKB105, which is RGBIT 6 ADC, and CR201, which is the PD-L1 bispecific antibody. That's where we are forming new collaboration on the treatment of oncology.
This is showing on what we have done in 2025 as well as year to date. You can see other than the approval of the products, I'd like to talk about the clinical progress, and then Dr.
Jing is going to give you a bit more detail. I'm just going through some highlights.
In terms of production, in 2025, the company has expanded our capacity for ADC. The ADC capacity expansion is to secure the market supply for 10+ clinical trials and 4 commercialized products.
At the same time, the HER2 ADC also was qualified for cross-provincial pilot production in China, make sure we can have rapid approval and launch for sale. In terms of commercialization in 2025, we are really starting as the first year of complete commercialization.
In the first half, the 3 approved products are all successfully included in the National Reimbursement Drug List, NRDL. Also, we have a commercialization team, marketing team with over 600 people, including marketing, medical affairs, strategy, excellence in operation, model departments, and as well as market compliances.
The commercialization team is not covering over 300 cities in China with 1,200 medical institutions, providing excellent new choice of treatment for patients. Also, Mr.
Ding, Mr. Zhou, and Mr.
Chen will elaborate further. In terms of capital market, we have H share placement in 2025 with the raising $250 million.
At the same time, our stock is also included into the MSCI Global Standard Index and FTSE Global Stock Index and Hang Seng Index and other indexes. In terms of capital financial market, that will be further covered by our CFO, Mr.
Zhou. Now this is some of the collaborated publication 2025.
You can see in 2025, we had published 6 pivotal studies in multiple academic congresses, and clinical data readout for Phase 2 and Phase 1 study, and also publication in renowned international journals, particularly 2 important blockbuster study, the OptiTROP-Lung04 study, which is the study for second-line EGFR-mutated non-small cell lung cancer, which is subject to an oral presentation and ESMO Presidential Forum. At the same time, at the same day, exactly, it was also published on New England Journal of Medicine.
These are some of the achievement of key registration and pipeline. We're going to elaborate a bit further.
Now, this slide is going to talk about the strategy for R&D. As mentioned, we now already have over a decade experience in terms of ADC.
With this experience ADC, we're going to name our platform OptiDC, which is the optimal drug conjugate. For every candidate, we're going to design and customize this design with specific target and mode of action with the best payload and best linker strategy to strike the balance in terms of efficacy and safety with our experience and know-how.
We are really using a multipronged strategy to drive the OptiDC platform. For example, in the field of oncology, our ADC is usually thought to be the replacement of the conventional chemotherapy.
We are now developing new targets with the bispecific structures, and the payload is also expanded to the common topoisomerase inhibitor and microtubule inhibitor when are developing some bispecific antibody drugs in the payloads. At the same time, we are exploring some non-toxic drug conjugates, such as radionuclides, PROTACs, or some molecules for tumor immunotherapy as payload.
Later on, we'll share some of the project which has entered clinical stages. In addition oncology, we also have non-oncology ADC for autoimmune disease and metabolic diseases with a new type of targeting mechanism, combining a chemical drug with small molecule to bring better safety and efficacy for disease in chronic disease case.
Now, I'm going to talk about the ADC and also the IO, including the subsequent integrated development strategy. When we are deploying ADC product, we've been really reaching strategic collaboration with our partners because, in terms of ADC and IO, we want to put them into combination as important direction for future development.
For example, in 2026, the first ADC plus IO in the first-line application, the data has been read out. Also we had already submitted PMDA, and we achieved the primary endpoint, which is PFS, in treatment of small cell lung cancer.
Also, we have observed a beneficial trend of OS. At the same time, there's some other ongoing study.
For example, 264 with pembrolizumab. Right now, in the non-small cell lung cancer, there are 9 global registration study for PD-L1, for the first-line non-small cell lung cancer, and also the combination therapy with Merck, with MSD.
In terms of lung cancer, breast cancer, and EC, we're also working on other partners like Biotheus with the PD-L1/VEGF, which is a bispecific. We'll continue to develop our ADC together to be used with the bispecific.
The combination use is really something we want to promote further. In SKB264, which is the PD-1 antibody, this is going to be another case of combination with many ADC in our portfolio.
Other than the combination strategy, we're exploring the strategy of integration, which means we have actually 2 projects where we have already filed IND. For example, SKB103, which is a bispecific ADC, which is dual target, TA plus IO, we have precision on-target activation, as well as the antitumor activity.
It's a dual target for both oncology and immunity. At the same time, we also have the 2-toxin 2-payload ADC with 1 toxin with 1 immune agonist.
This is another key project this year as well. Before I close my part, I'd like to really summarize a little bit here in terms of the development outlook for the company, and I'd like also talk about our overall strategy.
Our main goal is to continue to advance our differentiated pipeline. Also, clinically speaking, we want to address some of the unmet needs in the clinical setting.
At the same time, we're also going to optimize and innovate our ADC platform and also further expand our new type of payload, new linker, new ADC, and also to expand our antibody conjugate technology to non-oncology diseases. The third key point is to expand commercial partnership from R&D to production to clinical and commercialization.
This is really to build our capability throughout the chain and also through our global partnership, we want to expand our business footprint to develop and register and commercialize outside China. Now, okay, Mr.
Ding will cover commercialization.
Ding Nanchao
Okay. I'm going to take over on commercialization presentation as of 2025, the end of last year.
Kelun-Biotech, we have 4 products, multiple multiple indications officially entering the stage of commercialization. In 2025, the commercial team is working on brand building, team building, and also medication introduction, and business expansion, channel expansion.
All-around expansion to deploy the business, and also build a foundation for rapid ramp-up after the NRDL listing. In the first year, we this is the first year we have the non-NRDL promotion.
As of now, we have we have completed listing in all the provinces of China, covering 300 cities, 1,200 hospitals. We are now having some positive prescription.
At the same time, we cover 10,000 doctors and specialists. In 2025, we have over 1,200 academic meetings of various types for different medical institutions, large and small, different conferences, meetings.
Also, we published over hundreds of medical publications in professional media. Also, in academic meeting, we have received high recognition from international and domestic experts.
Our product in 2025 has been actually enrolled in multiple domestic guidelines into CSCO, [CACA?] .
Also, other than market promotion, importantly, we want to continue to complete our team build-up, focus on the systematic build-up of the commercial team. We want to build a team that can really thrive in a new competitive landscape and compliance landscape.
In 2025, we further, refine our medical and marketing department. In the future, a female-oriented gynecological oncology will be a team, and another team will be focused on lung cancer.
Also, we're going to reinforce our compliance and operation. In the second half, we have recruited more people.
In the last 2 quarters, we are now expanding the team member headcount to over 500 on the ground. The in total, the the general commercial team is close to 650.
With more, with more indications being approved, we continue to, and also with the 166 to be launched soon, we are now covering the market. Now, we are actually looking at even more, detail layout.
For example, in the second-line non-small cell lung cancer and also the ER-positive ADC, we really want our team to focus on promotion on finer details. This year, we we are valuing a lot in the second-line lung cancer and ER-positive, ADC and the 2026 NRDL listing.
We want to prepare for the expansion we expect. By the end of the team, the team will be exceeding 800.
Mr. Chen, over to you.
Wei Chen
Okay. Good evening.
In 2025, actually, for the whole company, I would say other than the achievement in commercialization, I think many investors and analysts, including our company, what we care the most is about the national negotiations. We are proud to say that actually 3 out 3 products and 4 indications have already been included into the medical insurance coverage.
In 2025, 3 products have been listings for the entire country, which is a great foundation for the hospital access that's to come. Now, at this stage, we are really driving full force in 166 for the national listing.
Of course, in 2025, this is still out-of-the-pocket for innovative payment system and also inclusive insurance in different provinces. We're also doing a lot of those.
We are covered by the inclusive insurance for more than 50 cities and also including 4 key provinces. Some of you might be noticing the second-line lung cancer where there's still out-of-the-pocket payment, but we are focusing a lot on the inclusion into the inclusive insurance in different locations for second-line lung cancer.
Like cities in Beijing and Hangzhou, at the end of last year, actually, the inclusive insurance has already been covering this. That's market access.
In terms of channel, actually, we are really building a lot of national channels like Sinopharm, Shanghai Pharma, and also China Resources as core distributors. The core distributor account for 90% our business.
At the same time, we deploy over 400 professional pharmacies footprints. Those pharmacies are really dual-channel pharmacies, laying a good foundation for the medical insurance landing this year.
After implementation in January this year, we added another 200 professional pharmacies, the coverage is making more accessible to the patients. Now, as you can see, we have a new product, which is the Lucan.
Actually, we have this new product because this is new product, we focus on the retail management in 400 professional pharmacies. We actually trained 10,000 professional pharmacists so that can serve our patients better.
This is some of the presentation on the commercial and collaboration last year. Now clinical pipeline, Dr.
Jing.
Jin Xiaoping
Good evening and good afternoon, dear investors. I will take a few minutes to talk about our product pipeline.
Our CEO already covered this. Like end of 2024, in a year or 2, we already have 4 drugs that are launched with 8 indications, including 1 NDA.
The NDA pipeline is for RET fusion, which is now being reviewed. Hopefully, we can get approval in the first half of this year.
We are really looking forward to it. Also, our partner, Ellipses, they're also engaging Phase 2 study worldwide.
We also hope the drug can be launched overseas. For Phase 3 projects, actually, in this year's ASCO, it's reported that the our ADC combined with immuno- immunotherapy that have been data, PFS is close to 16 months.
Oh, that's amazing data. Also, we have multiple Phase Phase 3 study with 264 combined with pembrolizumab in on patients with PD-L1-positive patients.
That research is also getting a positive results. Recently, we also communicating with the regulator.
Hopefully, we can deliver and submit NDA soon that's and this is now being receiving the designation of breakthrough therapy. We hope being designated as breakthrough therapy, we can have prioritization in review.
Also, in PD-L1-negative patients, we also have a Phase 3 study. We are enrolling patients.
Also, in 264 for EGFR-mutated population, actually, we already got approval. Actually, for Phase 2 and Phase 3, a lot of clinical data is actually showing the results.
Probably we expect good synergies in the combination. Phase 3 in last July and August, we already completed recruitment.
We are now actually following the patient up. Hopefully, we can submit NDA this year.
In breast cancer, ASMO in ESMO, we reported that 264 in the first-line, we have amazing data for breast cancer. PFS is 13 months already.
Now having a Phase 3 study in the first-line triple-negative breast cancer, and we have completed enrollment. Also, for another subtype, which is the ER-positive ER-negative breast cancer, CDK4/6 who fail CDK4/6 treatment, we are already engaging a large Phase 3 clinical study.
The and also, multiple pipeline has now moved from Phase 1 to Phase 2. There's 1 bispecific, which is 571, which is a blockbuster for us.
This is now moving to Phase 2 on multiple indications. We have multiple Phase 2 studies.
In the future, we also have a lot of plans for Phase 2 studies regarding that target. As I mentioned, many of the ADC pipeline is now exploring adding the ADC on top of immunotherapy for future applications.
In the future, we also expect a Phase 2 study combining PD-L1 and PD and also bispecific application. Also, there's another 1, 51A.
We're expecting a bispecific ADC to be expanded in multiple Phase 2 on multiple indications. Now when it come to Phase 1 program, compared with last year, we also have many pipeline that moving to clinical Phase 1.
SKB107, this is actually a for advanced solid tumor for oligometastasis. This actually, we are now in a in in a stage of dose dose expansion.
Hopefully, we can actually compare with multiple, other study to compare with other treatment for oligometastasis. SKB105, this is really an ADC, targeting RGBIT 6.
Also, actually, we have actually we are really looking for this drug to be used in combination with the bispecific PD-L1 for lung cancer, head and neck cancer, and other indication. Also, SKB108, which is which is also a bispecific with PD-L1.
This is we hope this is really could be combined with our own very ADC pipeline. We look forward to, SKB105 and also TROP2 ADC.
Maybe this can be forming a some sort of combo, ADC plus IO 2.0. 575, which is SKB575, which is This is a non-oncology drug in clinical phase.
As I mentioned, the vivo is just a 37A, which is TGF-beta antibody. This 575, this is actually based on this targeting TGF-beta, another type 2 inflammatory factor combined into a bispecific antibody.
Currently, the first indication is dermatitis. Of course, in the future, it might be used for asthma, COPD, and others.
We will be expanding the indications further. As mentioned, the CEO mentioned that we already submitted 2 IND applications, which are also from ADC monoclonal antibody ADC to bispecific antibody ADC, including the SKB103 mentioned before, we just submitted IND application and looking forward to the approval soon, which is a bispecific ADC targeting the combination of TA, tumor antigen, and PD-L1.
Also, there's SKB565, which actually dual payload, dual payload ADC composed of a cytotoxic and an agonist. We can see our pipeline from monoclonal ADC, which is now entering the stage of bispecific dual payload ADC.
Of course, we are looking forward to future of this bispecific dual dual payload ADC and advancement of the RET approval. The and the next page, our CEO mentioned just now, from the customer side, we are we are really supercharging.
We have 9 item in the third phase third phase, including those that are approved for testing, and those has been just started. Most of the multiple first Phase 3 study that have been completed and now now in a stage of follow-up.
We need to mention that this year for, we we, for the ADC, we are laying out the Phase 2 on the neoadjuvant in in in TNBC because in TNBC, we have really a lot of experience in combination for second Phase 2. We hope to move from second-line to second-line third-line moving to second-line and moving to first-line and even we can adopt the drug in the neoadjuvant therapy for some lung cancer with new rare mutation.
For MSD, well MSD actually conducting multiple Phase 3 study worldwide. MSD's strategy will be starting to focus on some differentiated indication, including gynecological gynecological tumor.
We can see 6 item in gyne tumor. Also, this is really for first-line and also moving to second-line and later line for ovarian, cervical, and also the uterus.
Also in breast cancer, there's also some differentiation mostly on the early stage like the adjuvant, third-line, fifth-line, and also some of the, neoadjuvant with some Phase 3 study. As mentioned, MSD just they are deploying this drug approval like the ASCO GU, we published the Keytruda combination on TNBC.
The data has been really amazing. PFS close to 12 months.
As a as a result, MSD is engaging a Phase a study for the second-line. Also, we mentioned like this year in ASCO and ESMO, gradually, we'll be reporting the data readout from large Phase 3 clinical study.
As you can see, for second-line EGFR-mutated, second-line TKI, particularly non-small cell non-small cell lung cancer after resistance of the TKI in the second-line, and also non-small cell lung cancer, after TKI or after chemotherapy in the third-line, and also for there's some also later-line data readout. Actually, from this capture micrograph, you can see you see a lot of OS data are really amazing.
A lot of OS benefit are really good, and particularly you can see the capture micrograph, long-term OS seem to have a long-tail effect. This is really similar to PD-1 kind of telling effect.
Whether the EGFR EGFR control or BTCA or and some other breast cancer, there's some hypothesis. Actually, we are testing this hypothesis.
Maybe they have a potential for immunity. Perhaps particularly for triple-negative breast cancer or the non-small cell lung cancer, I think in March, at end of this month, in the ELCC Congress in Europe, we'll be announcing the final OS result.
The OS is now close to 20 months for a patient after the TKI resistance, chemo resistance with EGFR mutation. Still, after the resistance, OS can still be that high.
It's really worth waiting. Also, the 166, the for small small cell lung cancer, right now in small cell lung cancer, the competition is quite intense.
The 166 is differentiated with some other pipelines because our toxins. The toxins is the only 1 that is that is targeting the microtubule MMAF.
This is a different payload, is different toxin. The linker design is also different.
You can see the safety spectrum compared with many other pipelines, we are very different. The we have very low incidence of interstitial lung disease, for example, a very mild hematological toxicity, mild GI toxicity.
In terms of efficacy, you can see in the Kaplan-Meier curve, you can see the hazard ratio 0.39. Particularly a different study and different drug, there's some difference in absolute PFS because they are enrolling different population with different history and different, lines of treatment.
Actually, the mean PFS could be different, but hazard ratio is something we can compare with different drug across different studies because our drug is for second-line and above. Hazard ratio 0.39.
If it's only second-line, hazard ratio will be even smaller. Also, there's a compared with TDM, there's significant benefits, including the ORR as high as 87%.
This is really differentiated for extra for HER2-positive breast cancer. Okay.
For my report today, I'm going to talk about the financial performance this year. The revenue and margin: In full year 2025, the company revenue was 2.06 billion, including the revenue with the external partnership, cooperation, and R&D-related revenue total 1.52 billion.
The commercialized revenue was 540 million. Total revenue increased by 6.5% compared with last year.
I have to make a note here: The commercialized revenue on the accounting statement, as per requirement of accounting rules, we need to deduct the inventory for the end of the year because deduction is related to the NRDL price adjustment, which means if you look at the price before the NRDL deduction, the revenue will definitely be higher than the number reported on the statement. Also, the second-half revenue definitely was better than the first half.
Secondly, the GP margin: Gross margin 1.47 billion. Compared with previous year, increased by 16.1%.
The growth was actually higher than the revenue growth, which benefit the change of the income mix. As I mentioned, last year, in our income mix, commercialization revenue was much higher than the previous year.
The commercialization revenue really benefit from our cost advantage. Because of the cost advantage for the drug, the commercialization's GM that's operated by ourselves, the gross margin will be higher than the gross margin with our cooperation or co-development.
Therefore, the gross margin will be trending higher than revenue. GM was moving faster than the top line.
The loss-wise, the total loss was 380 million yuan, which is indeed slightly higher than the previous year. The increase actually related to the financial structure because we have commercialization activity.
There are expenses for marketing and sales, particularly this was the first year of commercialization. In the first few years of the launch of a innovative drug, sales expenditure will usually be higher.
In terms of the profit contribution from commercialization, of course, the contribution was not as great as the profit contribution from external cooperation. Even though our top line was higher compared with previous year, the loss is actually higher.
Deducting the stock incentive options for employees, which is non-operational factor, the loss will be 210 million yuan. Now, this is the breakdown of the cost expenses.
The operating costs, as I mentioned, operating costs was 580 million yuan. The main component is because of the cooperation, the external cooperation, the investment in R&D, the personnel salary, and also the clinical trial expenditure.
This is the absolute majority of the operating costs. However, for the commercialized drug, the corresponding production cost is also included into our operating costs.
Because our production and CMC process are very advantageous, so, correspondingly, our commercialized product and corresponding production costs are relatively small in absolute amount. In terms of composition, the composition operating costs is mainly brought about by our investment in collaborative R&D.
Regarding our R&D expenditure, last year, it was 1.32 billion yuan, increased by 9.4% compared with previous year. Over the last 3 years, the trend of R&D expenditure is relatively stable, quite stable, actually I would say.
A slight increase, which is line with the expansion our business scale. Administration expenses also the same.
Last year, administrated expenses 180 million, increased by 8.6%, slight increase. Finally, sales and distribution expenses amounting to 475 million.
Compared with previous year, it was up by 160%, as mentioned, since last year was the first year of commercialization. We saw a significant increase in commercial revenue.
Correspondingly, marketing in early stage for investment in personnel or other conferences, marketing activity that also require investment to support the growth of commercial revenue. Therefore, the sales and distribution expenses last year show relatively large increase.
Next, the final part of finance presentation about the performance of assets and liabilities: By the end of last year, our total assets were close to 6 billion yuan. Compared with previous year, increased by 40%.
In the past few years, our assets has been increasing every year. Among which, the largest component is cash and financial assets.
Last year, cash and financial assets reached 4.6 billion yuan. The financial assets mainly include bank wealth management product, which are also liquid resources that we can use flexibly.
Therefore, the company's cash reserve are really abundant. The growth of the cash assets mainly due to Hong Kong placement in June last year.
We had about $250 million of financing through that placement. At the same time, the end of last year, also signed 2 new BD transactions.
The corresponding down payment will also have a positive impact on our cash position. Also, the scale of assets, including the cash reserve, has increased significantly compared with before.
On the liability side, end of last year, total liability were 1.12 billion RMB. Compared with asset side, the debt-to-asset ratio is very healthy.
The liability mainly include account payable under trade items, as well as contract liability, which reflect our financial performance. Now we move on to question and answers.
We are grateful for some analysts who actually make their way to come to our meeting room. If you have any questions, please raise your hand.
Also, those of you online, you can also ask question online. Feel free to raise your hand.
We see some hands already. Ziyi, why don't you start first?
Shen Ziyi
Thank you. Thank you.
This is Shen Ziyi. Two important questions: The first is for Dr.
Jing. This year, we care a lot about the first-line lung cancer, TPS, greater than less than I remember 05 and 06, 2 clinical trials, and also the readout, the first-line TNBC.
I'd like to really just confirm want to confirm when the date will be when will this data be available? When when this data available?
A second question that's more important, in the previous case, like we already like TPS greater than 1, PD-L1-positive clinical, we already read out the data. How do you how do you view the 2 data readout?
Because for MSD, some ongoing global Phase 3 study for first-line lung cancer, how do you interpret the outcome and impact? The 007 that they develop, which is also PFS about 50%, there's another file for squamous cell carcinoma first-line maintenance therapy 023.
How would the 2 data readout be read across? Their design are really different.
Dr. Jing, you just talk about you have 1 that is actually in combination osimertinib.
I wonder whether they will be read out this year. That would be my first question.
As Mr. Zhou mentioned, the commercialization achieve a revenue 540 million this last year.
Of course, that include the price adjustment with the NRDL insurance coverage. I want to understand the price adjustment.
If you restore the price adjustment, what will be the number be before the price adjustment? Also, end of the year, there's a target of 800 million to 1 billion target.
If there's a gap, what's the reason causing the gap to the year beginning year beginning guidance? How would I understand it?
In the current environment, particularly after the medical insurance inclusion, how how much is going to be the revenue from licensing? I want to understand the the amount of licensing and how much of the expensive R&D.
Okay. Thank you,
Ze Jian Zhou
Ziyi, for the question. I will refer the first question to Dr.
Jing. Secondly, regarding the sales outlook this year, and Mr.
Ding and also licensing revenue mix, Dr. Jing, would you start first?
Thank you. Those are some interesting questions.
Xiao Ping Jin
You can see as of now, second-line, third-line, and even first-line, we're moving to first-line, which is a bigger population. We already for 10G-male, we already have we already PFS, OS, we're already we are looking forward, in to release Q4 this year on ASCO meeting.
We might release that data then. For 10G-negative patient, it could be for for end of Phase 1.
For MSD, is mainly because the standard of care. Chinese SOC is different from global SOC.
Actually MSD have a Phase 3 study with TTS above 50. They didn't have enrollment for patient with TTS before below 50.
Maybe it's not convenient for them. Also, we already have 2 large Phase 3 study.
Maybe they're waiting for our data readout for the Phase 3 study. Secondly, you can see AC ACR, ACR this year, we might be reading out MSD might be reading out the the PVR, data.
Maybe that could be a combination possibility. EGFR mutation, we we talk about moving into first-line like TROP2 ADC.
There can some synergies with 264. There's a great synergy with 264.
We can actually enhance the the overexpression. This would be the best partner for the second-line.
In the future, we can see June last year, we actually completed enrollment, we have been waiting for the follow-up data. If the data is not available, good good thing, because with less follow-up data, it might be difficult to predict because we're going to have a very long PFS with the combination of chemotherapy.
We definitely will be better than the chemo alone. As I mentioned, we are talking about the primary endpoint for the second second Phase 2.
We hopefully, we are looking at data readout in next year's ASCO. Okay.
Regarding commercialization, in 2025, the TROP2 ADC, the Sac-TMT, the 264 has already out-of-the-pocket. There are some concerns when payment is out-of-the-pocket.
In that year, we focus on the brand building. Actually, we already seen excellent data, even it's paid out of the pocket.
With that great achievement with limited accessibility. In 2025, we've been focusing on meeting the unmet clinical needs, we focus on our data superiority to support out-of-pocket pricing.
In actual actions, we are driven both by the hospital procurement and DTP pharmacy. Mr.
Chen talk about we have a lot of DTP pharmacies, which is a pathway for clinical application for the non-generic drugs in China. At the same time, the full year, our pricing strategy is related to patients, but also related to the strategy for the NRDL medical insurance.
In our pricing strategy, we also have a patient care program. We have made adjustment to the patient program in the execution last year to make it more accessible to patients, but also lowering the threshold of accessibility.
Also, we have done a lot of online and offline commercial academic meetings with high-level KOL and department coverage to introduce our product philosophy. Also, in the first year of ADC used in China for breast cancer, we actually have some experience.
For lung cancer, we were really the first in China. We are the first trial lung cancer introduction in China.
We need to really deal with the communication for AE, building up the protocol of the ADC adoption and so we are really leading China, leading the world in this ADC, we've done a lot. Also, in 2026, what's the plan?
We are doubling the business in the future. In terms of strategic, we actually have 4 important things to do: like 2 drugs that have been enrolled in NRDL, 2 have not, how do we position them?
In the second-tier TNBC, we definitely want to establish the preferred choice in domestic TNBC in the second-tier cities. We must obtain the absolute leading position, leading market share in the market.
Secondly, in the HR-positive breast cancer, which we have just launched, our first goal is to establish a preferred plan after endocrine failure and chemotherapy failure. We know although we have competitors, our characteristics are really different, our focus are different.
I think our strategy is that no matter what the situation of the HER2 expression is, we'll win the market. Through the introduction of the concept, we'll lay the solid foundation for rapid development of the indication.
In term of Phase 3, which account for a big part of our current sales, our goal in this regard is definitely defining our TGI and patients. Also, in the second-line, even though we have SKI23 and also 410, and those are NRDL, but we do have our data advantage.
We have better data, we have better compliance, we have better safety, and so we're going to promote our advantage through academic promotion so next year, once our indication was covered by NRDL, the entire EGFR-mutated second-line will be the preferred drug. By our planning, the NRDL revenue will account for more than 80% for our revenue.
This year, we have several data readout like the gefitinib and also the non-small cell lung cancer and GI, and also we're going to explore more oncology. Any more questions?
Shen Ziyi
Now, I think there's a question, a lot of people interested. We we we talk about so in terms of commercialization, the results has been in line with our expectation.
Of course, this is really the beginning, the first year of commercialization. Particularly, when we make sure we connect the last mile, it's really from 0 to 1.
Xiao Ping Jin
It's really starting it is is a it take a progress. It take a process for for us to build a team, allow the team to access the market.
Always speaking, our parent company has been providing commercialization resources and support. In the past year, our sales has been growing very positively, including hospital listing, hospital access, the pharmacy expansion, the pharmacy coverage, and the product commercial sales.
I think we are seeing a growth trajectory. At the same time, this year, well last year, we had 3 products that are enrolled in the NRDL, and the medical insurance negotiation have been quite successful.
You can see the price we get quite good. For this year, in terms of commercialization, we are very confident for this year's commercialization.
As Mr. Ding said, definitely will be double compared with last year.
Just 1 more thing: Like most important this year, after a large-scale kind of work, we're going to focus on small-scale development. I think we we we Well, because in the clearly in China, we have the Two Sessions talking about the support for innovation.
We're clearly feel that now that we're covered by NRDL, in less than a quarter, less than a quarter, now top 100, top 200, and top 300 hospitals, we are doing very well in the listing in the top hospitals. As long as they have the pharmacy meeting, our listing will be completed once they have the pharmacy conference discussing including our drugs.
Thank you, Mr. Ge, Mr.
Ding.
Ding Nanchao
Ziyi also talk about after the licensing revenue, how much was related to the R&D reimbursement? There's a trick here because in terms of the co-development reimbursement, is accounted as revenue and cost at the same time.
They're not exactly corresponding because reimbursement has its own logic. It can be based on costs, but it can also be used as a reference.
As I mentioned, in our revenue, a lot of revenue actually is coming from the cooperation and development. You can see in the number.
The cost and revenue is a great reference, but they are not exactly 1-to-1 ratio.
Zhang Qing )
Okay. Now, this is Zhang Qing.
I'd like to talk about commercialization. Now that you have a team commercialization operating, now you should invest more in R&D and more in resources.
My question is: Breast cancer and lung cancer team, how would you address the staffing for the breast cancer team and lung cancer team? Also, the second question is looking at the overseas market launch, what are the indication?
Wei Chen
Hopefully, we can see some overseas data in this year. First on breast cancer commercialization staffing, and MSD's overseas expectation.
Dr. Jing, maybe you can cover the question?
Xiao Ping Jin
Thank you. In terms of indication, and indeed, we have a lot more breast cancer.
Lung cancer has a lot of population, we definitely will have more team members for lung cancer commercial team. Also in terms of ratio, lung cancer will be more than breast cancer.
In terms of development, in all the top hospitals in the country, we started from the first-line post. We separate the team working on lung cancer and breast cancer.
Because in China, there are so many number of hospitals, we mentioned we cover 1,200 hospitals in a non-NRDL provinces, and this year, we're going to double the coverage with NRDL inclusion. We're going to cover all the tertiary hospital from provincial, municipal, and county level.
We still want to bundle some of the team in some of the hospitals, but we're going to separate breast cancer and lung cancer for key hospitals, key province, and key cities. Thank you.
For indication, I think we looking forward to the indication approval this year. Main strategy is to be combined with pembrolizumab in the first-line, even earlier for neoadjuvant therapy.
It will take some time because it would take time for enrollment and follow-up. The first indication should be endometrium carcinoma.
Thank you.
This is [Huoluobi?] .
Thank you for having me. My first question for Mr.
Ding about sales: The 3 products are now listed for NRDL. This year, you want to double the sales for 264, but what about sales guidance for 140, 166, and 167?
Second question, Dr. Jing talk about the PFS data for PD-L1-positive patient should be read out in ESMO, and the negative patient is also ESMO.
Dr. Jing, other than ASCO and ESMO, what other data could be read out this year?
Also, Dr. Zhou, Mr.
Zhou, can you talk about the revenue from MSD? If there is a potential DLA, what is the potential milestone payment from MSD?
Okay. Firstly, other than 264, what about other sales guideline for other drugs?
Also, ASCO, ESMO, what about other data readout? Dr.
Jing.
Xiao Ping Jin
Okay. The few products they are now NRDL covered: 140, we have good progress and good opportunity because this is the first in the world head-to-head study with original drug, we're different from another 1 from China.
Also, our product safety and efficacy has been well received by the market. Also, we also have a benefit in terms of pricing and channel compared with the original.
Also, this is a very mature product, we can actually ramp up really quickly after hospital listing. That's for 140 140.
For 166, I think it is still non-NRDL, and also you can see the respiratory medicine is a crowded space, we want to price ourselves differently. Though 166, we are outstanding in terms of HR, AE, toxicity, but we want to differentiate versus AD215.
Also, next year, we want to really, just pave the groundwork. Once we got NRDL, definitely we want to have more synergy with ADC.
It doesn't have to be used after A21, we can actually use it before and after. Now for the drug 117, indeed, there's a lot of product of immunology in China.
After NRDL inclusion, we want to explore combination therapy.
Thank you. For the data, ESMO is a bit early.
ESMO will be in October. We are just still planning on this.
Xiao Ping Jin
There are a few things. We still have a lot of to do.
For example, for Phase 3, I think when the plan mature, we're going to read out the data. This is 1 thing we're still planning.
Of course, that depends on the progress in the Phase 3 study. As mentioned, for PD-L1-negative, we expect to announce the results at the Istanbul meeting, including the first-line TNBC.
We need to see the timeline there because we're waiting for the result. For ASCO, now maybe results coming out by the end of March.
Perhaps the abstract may not be released yet. In addition to the PDA online meeting, we have our 5 500 pipelines.
Some of the pipeline, we want to go to Phase 3, or maybe we can come out with a readout Phase 2 data to be presented on ASCO, but depends whether that can become concluded before ASCO. In terms of milestone this year, we have some R&D collaborative income.
We explain that this revenue on the book is not 1-to-1 correspondent to the receiving to the receiving of the payment because there is some in terms of accounting treatment, there it could be stagger because the requirement of accounting principle for installment recognition according to the standards. Precisely because the pipeline, they triggering some milestones, and this all going to be stagger.
Therefore, you can see the statement in the past 3 years, in terms of recognition of the revenue from cooperation, it's very stable, quite stable over the last 3 years. This year, we're going to have some more pipeline to trigger milestone payment, and they will be recognized accordingly based on the accounting principles.
For 264, you mentioned 264, we just talk about there's upstream with the milestone, total amount is $1.5 billion, and we have been disclosing the payment receive. Up to now, actually we are receiving about $200 [million] to $300 million so far, if you don't account for the reimbursement, right?
Actually the majority will be received in the future. As Dr.
Ding mentioned, particularly you talk about the voucher and and so after it was approved to be listed in in the U.S., it will trigger several income: development milestone, and also the second, the commercial milestone. When you get to a certain commercial sales, it's by different gradients, right?
Development milestone followed by commercial milestone, and the thirdly, there's a sales royalty. It's really a royalty, sales commission.
A certain percentage will be taken from every penny sales, and this percentage is also tiered, which is segment by different stages. The higher the income, the higher the percentage the commission we got.
We have made announcement to the make a disclosure of this before. Overall speaking, the cooperation income will be contributing greater and greater contribution as the pipeline become more mature, as our cooperation making more contribution.
Okay. Congratulations.
Very happy to see we have more Phase 1, Phase 2, earlier pipeline. Congratulations.
My question is: In Phase 1, Phase 2, and even earlier pipelines, What are the high priorities? Is it bispecific, ADC, or non-oncology?
My second question is about the PD-L1 monoclonal antibodies because you can see now you have PD-L1, EGFR. Now, you can see people really like the combo, PD-L1, EGFR.
Also with such a second-generation bispecific like second-generation IO plus ADC, now in the future, we might have second-generation IO with ADC. This is really special combo, PD-L1, EGFR, combined with your IO.
The data in China, this is quite specific, PD-L1, EGFR, and the data in ADC, particularly from China, how would MMC interpret your data for you? What is the impact from licensing some of the ADC assets?
Ze Jian Zhou
Thank you. Thank you for the question.
The assets priorities for Phase 1, Phase 2 early assets, Dr. Jing, maybe you can take this?
Mr. Ge, you can talk about strategy.
Secondly, you talk about if we have some Chinese data for bispecific, which is comparable to ADC, how would it help us? What would MMC look at our data?
Ge Junyou
You talk about earlier pipelines. It's difficult to say any priority because these pipeline, they are not targeting the same target.
It's not like we have multiple pipeline for the same target. You can see even though we have bispecific ADC, but they are actually different.
Some are TA like tumor antigen like 571, they are really addressing different targets for different tumor antigens. You can see the 103, which is a TA and PD-L1 bispecific, is actually targeting the tumor antigens combined with immune PD-L1.
Actually, we hope the bispecific, they can enrich the tumor microenvironment, improving the tumor environment. Then, we talk about the bispecific, is actually a agonist plus a cytotoxic.
For every pipeline is different. Every pipeline is dealing with a different question, a different clinical problem, different setting, different scenario.
It's difficult to say which 1 carry more priority. You can see our important pipeline, we have TSLP bispecific and also TGF-beta antibody.
Our half-line is actually 60+ days. Then you can have a dosing every 6 months.
With TSLP in combination, you can actually have great synergies. In terms of efficacy, it will be better than PD-L1.
It's difficult to say which pipeline will be more prioritized. We want to drive them together, either they're best-in-class or first-in-class, we want to be more flexible, maybe more flexible combination with ADC.
Okay. The second question related PD-L1 for ADC: You are doing clinical study in China, you're thinking about global implications.
I don't think I need to answer that question because a global MMC, they are more and more receptive for the early data from China. You can see MSD.
MSD, they have 17 clinical study, clinical 17 Phase 3 trials. They don't have their early-stage data anymore.
Whether it's gynecology, urology, lung cancer, they are doing Phase 3 studies. They don't have early data already.
They use our early clinical data. You can gradually in the SGO, which is a gynecology congress, and reporting data, the data reported are actually all coming from us, from our Phase 2 data.
This is helping the global study, including MSD. MSD, they are doing study like the ADC trial 2, which is combined with Canada.
Many
actually, they're doing Phase 3 study, but actually much data are actually coming from China. I think people are now getting used to Chinese early-stage data because we have patient resources in China, we have the advantage of doing clinical trials in China, we have great investigators in China, many investigators in China are international.
MMC are happy to take Chinese data. Of course, we also want the MMC to do global Phase 3 study.
Actually, I didn't make myself clear. I want to clarify my question.
For every PD-L1, EGFR, every PD-L1, EGFR are different. You are getting a very new molecule, you actually have the new data in China.
How would this Chinese data help the MMC to believe that your ADC in a combo, how would they how would they be compelled to use our ADC in a combo with their molecules? If they're using their own drug, can the combo produce the same result?
Ge Junyou
That's a great great question. You can see the 11A molecular structure.
You can see what's the purpose. We are very interested in this molecule because the MMC interested to buying the molecule because this is very similar to their molecule.
I believe that in this traveling structure, which is based on PDB, our molecule is very common to this common 1. This is why we're confident that we can accelerate development of the ADC with a flexible PDB structure.
Our BDC, whether using combo with our own pipeline or with other pipeline, we're confident. Of course, we're driving a lot of our own ADC bispecifics.
Hopefully, we can promote the joint development. You have an excellent question: Not all the PD-L1, EGFR are the same.
Of course, there are lots of differences, different design, different risk. Not all the PD-L1, EGFR are born the same, not all ADC are the same.
The same thing, not ADC are all different. It's not possible to just copy the combination with another drug.
You still have to look at the P2P structure interface.
Thank you. Thank you.
I have a question for Mr. Zhou.
Now, regarding priority of a pipeline, I think for us, indeed, you can see we are not having many pipelines. We don't have many pipelines.
Actually, as I mentioned, every pipeline initiation mean to PCC or IND, every molecule is actually looking at a OPTC. We have done a lot of comparison, horizontal and vertical comparison.
We have high hope for every pipeline. Of course, it's based on risk and data finally.
It may not succeed, but at least in early stage, we do more work and to to drive it, and to to make the chance to move into clinical. Every pipeline is something that we we take a lot of, pride in.
We are very prioritizing every pipeline. We hope they can be druggable.
The second question for PD-L1, VEGF, PD-L1, VEGFR, I think it it is a very hot topic, very hot target, but can you really develop PD-L1, VEGFR interface? Also can you demonstrate better efficacy compared with single-target IO?
Ze Jian Zhou
Right now, you don't know. You don't know whether combination is better than monotherapy.
It's something we need to explore. At least from right now, PD-L1, VEGFR in in synergies with ADC, I I think people really have high hope.
People really believe that it's going to be successful, or more very likely it will be successful, that combination is better than monotherapy. How will how will use the data in the future?
Our partners: I hope our partner will use our data in combination because only get the rights in China, they can they can license the right for outside China, they can use it. We hope to have a potential value for global development.
Secondly, people are also exploring which is the better PD-L1. We want to draw the conclusion, which is the better PD-L1.
We have to find out by exploration. We have to explore.
We hope to have more data to answer the question: Which is the better PD-L1? Thank you
for having me. Two quick questions: Try to understand your internationalization strategy.
Many company, large and small, they are looking outside of China. My question is: Mid- to short- to long-term, what's your strategy for internationalization?
Second question: With a lot of AI application in China, in the world, many company using AI. Is your company doing anything in AI?
The first question on internationalization, Mr. Ge, you can take this.
The second question, the use of AI, Dr.
Ze Jian Zhou
Song and also Dr. Yu, they can talk about the use of AI.
Mr. Ge, you start first?
Ge Junyou
Thank you. International strategy: As I mentioned the last slide of my PowerPoint, we position ourselves to be aiming or aspiring to be an international company.
We have a clear pathway. We are working with MMC and series of international partnership to build the international R&D and development capability.
As I mentioned, in our cooperation with MSD, they need our early-stage clinical. Many international multi-center is done by Korea, done by us, done by our team.
They can use our team to go to FDA to register for Phase 3 clinical trials. We're building our team and building our capabilities.
Apologies, there's some audio issues from the conference room. When it come to AI application, I think we are not just doing it for the last 2 years.
If you trace back, we've been doing this for quite a long time. Right.
When AI was not so trendy yet, even in Rednotes, we are recruiting an experienced director to build our platform. When AI starting to be popular, we already using AI application in our departments.
As AI is mostly used in the front end of pharmaceutical R&D, and we're just gradually building the maturity. Far, whether it's a small molecule, or the large molecule, or translational medicine, in the upstream, we are really using AI, actually using AI application in terms of upstream R&D.
For example, let me show you an example in small molecule platform. We've using some of the early-stage AI startups.
We've been using their AI products, we know some of the models that are pretty good in terms of explainability, credibility. We're building relation with some great partners already.
Secondly, other than building partnership, we have our own very own AI department. We are not just using AI model, we are building our own model.
Why are we building our own model? AI has a lot of appetite for data.
It's important to have your data from your own platform. We've been doing R&D for 10+ years.
The compounds, many bio medicine tests, a lot of data is in our database. We have our own model, which is a great way to use our data.
Shen Ziyi
We're not just using the data in a small molecule R&D, but also in our ADC. You can see you can make all kinds of linker structure.
If you are synthesizing every molecule and you have to validate it after synthesis, it take a lot of time. We can use AI software for the molecular synthesis and to predict the property of the molecule.
It's a very helpful. Back to small molecule, it's even more simple because we make a good achievement in small molecule because small molecule R&D is less difficult.
There's a very significant overlap in pattern overlap. If you only optimize the structure of a known structure, you're very likely to be hit by a patent risk.
Now we have AI, we have abandoned that model.
Ge Junyou
We actually start from molecule with brand new structures. In symbiology, genotype determine phenotypes.
Actually your advantage come from the molecular structure. You can actually sense the help from AI to R&D.
Now, back to ADC: Many complicated linker, we have tried different linker, different combination. In the end, we have to differentiate in indications.
That is actually very helpful in translational medicine because by using some open-source model, we're building our own very model. Our medicine is actually finding a better differentiation in the clinical indication, the clinical application so that we can meet the needs.
Also in biomarker, actually AI helps with a lot of promotion. Also large molecule as well in antibody optimization, bispecific, we are feeling really if we have not been using AI few years back, we are not able to really leverage the advantage in the program.
We are confident that the AI department with the data sharing, we're going to really benefit from this advantage. Dr.
Tan, Dr. Yu, anything that you want to add to this?
Xiangyang Tan
Let me just add a couple things. I think Dr.
Song has been quite comprehensive. We have our own R&D, we have our AI team, our AI department.
However, we also spend a lot of effort to seek out the top AI companies externally where they are doing well in innovative drug AI technology, and we are building a collaborative relations with many companies. AI is now being used in Kelun-Biotech in a few ways.
AI helps to improve the quality of our projects. For example, right now, we have a lot of best-in-class and first-in-class efforts.
Secondly, AI is helping to accelerate the progress of the projects. In these 2 regards, several projects have really benefit from AIs.
Also, of course, when it come to ADC, it can help us to predict the payload, linker property, and the druggability of small molecule. AI also help us with the challenge in terms of the synthesis SAR.
All these are where AI can play a role.
Thank you.
Ze Jian Zhou
Matthew?
Matthew Culley
Thank you. This is Matthew.
My question is about Phase 2 clinical C10. Some time ago, MSD also have a level 2.
What's your expectation in the coming year of readout compared with Astellas' asset, how is it different from the Astellas? My second question is the STING in the pipeline has removed A269.
What's the consideration? Now, first of all, thank you.
Regarding this question, the first question, we license the global equity to MSD entirely. Secondly, the STING, because this is a small molecule?
Xiao Ping Jin
As I mentioned, we license to MSD. MSD is doing this global development.
It started out with domestic development, but after getting the molecule, MSD might want to do some technical transfer, it may take a bit of time. Phase 1, Phase 2 in China, and then they're going to do global trials.
It takes some time for technical transfer. Right now, it's actually going on very well.
They have launched some Phase 2 study on multiple indications. Compared with Astellas' EV, it is mainly targeting topoisomerase.
The molecule is similar to 264 ADC, have the same payload and linker. Therefore, with the success of 264, we are very confident in the molecule.
Also, the molecule is very different from EV because EV is a MMAE drug. MMAE has a lot of side effects and toxicity in dermatology, neurotoxicity.
Our molecule can cross a blood-brain barrier. We have tried ADC through the 264, and the data has been amazing.
We hope in the future, we can have good target for cervical cancer, breast cancer. Also, compared with EV, we really have a different payload toxin, which means it's easy to breakthrough into new indications.
Now, the second question on STING, the small molecule: Actually this molecule is 1 that have been tried in earlier stage. Right now, you can see someone else also remove it from the pipeline.
Immune agonist, everybody want to do immune agonist. Lots of people have tried.
A lot of them have been failure, including the small molecule immune agonist. Maybe the failure come from the lack of efficacy.
People are saying actually whether immune agonist plus PD-L1 will be okay, but I think it's not able to get a good results.
Xiangyang Tan
This is the reason why we're not spending too much effort on this. Also on 565, they also have an immune agonist as a payload.
This is where we want to focus on. With this payload, we want to improve the efficacy.
For STING, whether it's in tall or STING, this is the first attempt. Even though we are not promoting it to clinical trial, it doesn't mean we have stopped the pipeline R&D.
We'll continue to build data from R&D, the clinical, and iteration. You can see our data and the TLR receptor molecule, and other small molecule and other isoform with those as target, they are actually using antibody with this immune agonist.
Xiao Ping Jin
By building this data, we now understand the immune agonist, a single target, the druggability is limited. It's difficult to strike the right balance between efficacy and the safety.
Also, you can see in order to avoid activation of the entire body's immunity, it will have less activity. In terms of clinical ramp-up, then it's difficult to get the PK or PD.
Because if you have efficacy, you're going to have immune activation. Whether it's a small molecule or ADC, we don't want to get people into Grade 5 AE just because we want to have efficacy.
We found this type of molecule, they do need a partner. They need a partner to act.
They itself mainly act to activate immunity. Then there's another molecule, another mechanism.
Ding Nanchao
This is why we follow up with the 515, as Dr. Jing said.
We'll have the immune agonist combined with the cytotoxic with dual payload. We are actually researching on the combination mechanism.
We want to see what is the best receptor agonist, we are iterating design. I think that's still promising.
It should be something that provide a better balance with both efficacy and durable efficacy. Maybe we can take final 2 questions.
Maybe Wang Xueyu? There's a question on the financial statement: Price adjustment, you talk about what's on the inventory.
For whatever in your stock is already priced based on the adjusted reimbursement price. Also, will the expenses be recorded in the sales expenses when you're cooperating with the pharma?
These are 2 questions. We are working with pharma, as mentioned, 140, we make an announcement for 140.
Clearly, we have a CSO model for 140. We're going to commission a pharma.
140 is focusing on the first-line colorectal cancer, right? There need to be someone who have resources for GI, and also thinking about this business, we have some commercial collaboration with CSO model on the project of 140.
Any revenue generation, it will be booked to Kelun-Biotech, but we'll also book the corresponding expenses. The expenses will include the payment to sales services, promotion services, but from Kelun-Biotech, the recording and expenses are all recorded here on our own company.
Ze Jian Zhou
On the online audience? Thank you.
Thank you for having me. I have 4 I have 2 follow-up questions.
The first question is: You can see like this year ASCO will read out the PD-L1-positive data. Do you split the cohort between squamous cell and adenocarcinoma?
Because MSD in their indication do split between squamous cell versus adenocarcinoma. I want to know whether the TROP2 ADC's cohort will be differentiated.
My second question is: Last year in HER2-pos HR-positive, HER2-negative breast cancer, that was PFS result, which is amazing, and also a beneficial trend of OS improvement. I want to know is there any more data regarding the upgrade update of OS maturity?
Because in AstraZeneca, OS is not significantly benefit better than the control group, which really compromise their sales.
Ze Jian Zhou
Just want to know do you have any update? Yeah, 2 detailed clinical question, Dr.
Jing.
Xiao Ping Jin
First question: Indeed, we're going to record both squamous cell and adenocarcinoma. Those will be data readout accordingly.
Secondly, to positive HER2-negative, yeah, indeed, for indication, MMPA has been approved. For final OS analysis, because it's event-driven trial, the timing doesn't come as fast as you think.
We hope maybe in this year or maybe in next year's ASCO, we might be able to have final OS data. There are more and more drug coming on, including A201, A111 from China, and also a lot of patient will be using this type of drug.
Also, subsequent new OS, we're going to see some OS improvement. As I mentioned, we are very confident in our TROP2 OS benefit because in terms of lung cancer because subsequent treatment for OS is a bit less, lung cancer should produce bigger.
We are having a positive results in the 30 3A5 in OS. We are significantly behind schedule, we're overrun a lot on time.
I know you still have many questions, but going forward, we're going to go to Hong Kong, we're going to have some offline communication, NDR roadshow in other cities. If you have further questions, feel free to join our offline roadshows.
Mr. Ge, can you wrap up?
Ge Junyou
I think you have summed it up pretty much. I like to just leave you with a thank you.
We thank all the investors and analysts for your interest, attention to the company. Every time, you have had great questions for us, which help us to think.
This is a great help for the company's development. Also, in the future, there's going to be even more activities to line up.
We hope to see you more often in the future. Thank you.
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