Sichuan Kelun Pharmaceutical Co., Ltd. (SHE:002422)
China flag China · Delayed Price · Currency is CNY
33.64
-0.39 (-1.15%)
May 8, 2026, 3:04 PM CST
← View all transcripts

Earnings Call: H2 2025

Mar 23, 2026

Operator

Thank you for joining Kelun-Biotech earnings call for 2025 annual results. Within next one 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 clients or used internally for reference and distribution. Any forward-looking statements made during this call are based on current expectations and assumptions made by the management. The company undertakes no obligation to update or revise unless required by laws or regulations. The audited information is just for reference only and should not be considered as investment advice or guarantee of the future performance.

Zhou Zejian
CFO, Kelun-Biotech

Okay, let me introduce you. 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. Jin. Chief Commercial Officer, Mr. Ding. Chief Officer for Distribution Management and Market Access, Mr. Chen. VP of Small Molecule R&D, Dr. Song. And myself, CFO, Zhou. I'm gonna pass on to the CEO, Mr. Ge, for the presentation. Over to you, Mr. Ge.

Ge Junyou
President and CEO, Kelun-Biotech

Thank you. The 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 four parts. I will start with myself covering the business overview and the business highlight in 2025. The second part will be covered by Mr. Chen for the commercialization. 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. You know the company very well. The company has been established for over 10 years.

The real differentiation, our technical platform and pipeline, we're becoming a leader in the innovative drug industry of China. The core of our R&D is the OptiDC, which is the antibody conjugate, you know, technical platform. Also Merck and Kelun Pharma are the two largest shareholder. There's a reason we are getting the resources from the top players from China and U.S. to drive the company forward. We have over 30 R&D projects, including four products that have been launched in the market with eight indications. The one in NDA and 10+ projects in clinical development stages. We expect in 2026, this year, more product will be approved in China with more indications expanded. Our 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 gonna talk about the pipeline for the company. As you can see, starting from the lab, we have four launched products and one 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.

We have approval for second-line and above for, you know, the HR-positive HER2-negative breast cancer. Last year, the HER2 ADC, which is the trastuzumab botidotin, which was also approved in China in October last year, making the first HER2 ADC approved for HER2-positive breast cancer. Additionally, we'll have two more product names. Cetuximab for RAS wild-type colorectal cancer, monoclonal antibody and CR-001, as well as PD-1 drug for nasopharyngeal cancer as a third line, the first line treatment approved last year and shown on the table on the right in addition to trastuzumab injection. We have also nine other ADC projects in different stages, and new conjugate drugs, differentiated targets in 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. So this is the pipeline. Now, moving on, Kelun-Biotech values 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. This last year we've been working with MSD, Liposis and Bio and Crescent Biopharma. We signed multiple licensing out agreements for cell and gene therapy.

You can see our partners have started 17 global phase III clinical trials, including five for lung cancer, four for breast cancer, six for oncology, one for gastric cancer, one for urinary oncology covering all the way from second line, third line to first line, even adjuvant and neoadjuvant therapy. Last December we partnered with Crescent Biopharma for commercialization efforts, including SKB105, which is ITGB6-ADC and CR-001, which is the PD-L1 bispecific antibody. That's where we are forming new collaboration on the treatment of oncology. This is showing what we have done in 2025, as well as you know year- to- date. I can see other than the approval of the products, I'd like to talk about the clinical progress, and then Dr.

Jin is gonna give you a bit more detail. I'm just going through some highlights. First of all, 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 four 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 of a sale. In terms of commercialization in 2025, we are really starting as the first year of complete commercialization. In the first half, the three approved product are all successfully included in the national reimbursement catalog, or NRDL.

We have a commercialization team, marketing team with over 600 people, including marketing, medical affairs, strategy, excellence in operation, module departments, and as well as market compliances. The commercialization team is now covering over 300 cities in China with 1,200 medical institutions providing excellent new choice of treatment for patients. Mr. Ding, Miss Zhao and Mr. Chen will elaborate further. Into the capital market, we have share placement in 2025 with raising $250 million. At the same time, our stock is also included into the MSCI Global Standard Indexes and FTSE Global Equity Index Series and Hang Seng Index and other, you know, other indexes.

In terms of capital financial market, that will be further covered by our CFO, Mr. Zhou. Now this is some of the cooperation that you know collaborative publication 2025. You can see in 2025, we have published six pivotal studies in multiple academic congresses and clinical study data readout for phase II and phase I study, and also publication in renowned international journals, particularly two important blockbuster studies, the OptiTROP-Lung04 study, which is the study for second-line EGFR-mutated non-small cell lung cancer, which is you know subject to 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 achievements of key registration, the pipeline.

We're gonna 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 ADC, we're going to name our platform OptiDC, which is the optimal drug conjugate. For every candidate, we're gonna design and customize the design with specific target and mode of action, with the best payload and best linker strategy to strike the best balance in terms of efficacy and safety. With our experience and know-how, we are really using a multi-pronged strategy to drive the OptiDC platform. For example, in the fields 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. The payload is also expanded to the common topoisomerase inhibitor and microtubule inhibitor when developing some bispecific antibody drugs, you know, in the payloads. At the same time, we are exploring some non-toxic drug conjugates such as radionuclides, proteasomes, or some molecule 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 chemical drug with small molecule to bring better safety and efficacy for disease, in chronic disease cases. Now I'm gonna talk about ADC and also the RO, you know, including the subsequent integrated development strategy.

When we are deploying ADC product, we've been really, you know, reaching strategic collaboration with our partners, because in terms of ADC and RO, we want to put them into combination as important direction for future development. For example, in 2026, the first ADC plus RO in the first-line application, the data has been read out. We have already submitted pNDA, and we achieved the primary endpoint, which is PFS in treatment of small cell lung cancer. We have observed a beneficial trend of OS. At the same time, there are some other ongoing study, for example SKB264 with pembrolizumab.

Right now in non-small cell lung cancer, there are nine global registration studies 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 by person bio with a PD-L1 VEGF, which is 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 SKB10A, 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 two projects where we have already filed R&D.

For example, SKB103, which is bispecific ADC, which fuses targets TAA plus PD-L1. 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 dual payload ADC with one toxin and one 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. You know, in terms of the development outlook for the company, and I'd like to 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 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. Mr. Ding will cover commercialization.

Ding Nanchao
Chief Commercial Officer, Kelun-Biotech

I'm gonna take over on commercialization presentation as of 2025, the end of last year. Kelun-Biotech will have a full product, multiple indication 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, this is the first year we have the non-NRDL promotion. As of now, we have complete 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 institution, large and small, different conferences as meetings. Also we publish 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 2020-2025 has been actually enrolled in multiple domestic guidelines in CSCO, AACR. Other than market promotion, importantly, we want to continue doing 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 you know refine our medical and marketing department in the future, female-oriented gynecology into oncology will be a team. Another team will be focused on lung cancer, and also we're gonna reinforce our compliance and operation. In the second half, we have recruit more people.

In the last two quarters, we are now expanding the team member headcount to over 500 on the ground. In total, the general commercial team is close to 650. With more indications being approved, we continue to expand. With the A166 to be launched soon, we are now covering the market. Now we are actually looking at even more detailed 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 have varying a lot in the second-line lung cancer and ER-positive, you know, ADC and the 2026 NRDL listing.

We want to prepare for the expansion. We expect by the end of the year, the team will be exceeding 800. Mr. Chen, over to you.

Chen Wei
Chief Officer for Distribution Management and Market Access, Kelun-Biotech

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. Well, we are proud to say that actually three products and four indications have already been included into the medical insurance coverage in 2025. Three products have been listed 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 A166 for the national listing.

Of course, in 2025, this is still out-of-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 four key provinces. Some of you might be noticing by the second-line lung cancer, where there's still out-of-pocket payment. We are watching, 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 Pharmaceuticals, and also China Resources as the core distributors. The core distributor accounts for 90% of our business. At the same time, we deploy over 400 professional pharmacies footprints. Those pharmacies are really few channel pharmacies, laying good foundation for the medical insurance landing this year. After implementation in January this year, we added another 200 professional pharmacies, so the coverage is making more accessible to the patients.

Now, you know, as you can see, we have a new product. So well, actually, we have this new product because this is a new product, so we focus on the retail management in 400 professional pharmacies. We actually trained 10,000 professional pharmacists who can serve our patients better. This is some of the presentation on the commercial and collaboration last year. Now clinical pipeline, you know, Dr. Xiaoping.

Jin Xiaoping
Chief Medical Officer, Kelun-Biotech

Good evening and good afternoon, dear investors. I will take a few minutes to talk about our product pipeline. You know, our CEO already covered this, like end of 2024.

You know, in a year or two, we already have four drugs that are launched with eight indications, including one NDA. The NDA pipeline is for RAS fusion, which is now being reviewed. Hopefully, we can get approval in the first half of this year. We're really looking forward to it. Our partner, Elix, they're also engaging phase II study worldwide. We also hope the drug can be launched overseas. For phase III projects, actually in this year's ASCO, it's reported that our ADC combined with immunotherapy, there have been data. PFS is close to 16 months. That's amazing data. We also have multiple phase III study with SKB264 combined with pembrolizumab on patients with PD-L1-positive patients. That research is also getting positive results.

Recently, we're also communicating with the regulator, hopefully we can deliver and submit NDA soon. This is now being receiving the designation of breakthrough therapy. We hope, being designated as breakthrough therapy, we can have prioritization in review. In PD-L1 negative patient, we also have a phase III study. We are enrolling patient. In SKB264 for EGFR mutated population, actually, we already got approval. So actually for phase II and phase III, a lot of clinical data is actually showing the results. Probably we expect good synergies in the combination. Phase III in late July and August, we already completed recruitment. We are now actively following the patient up, so hopefully we can submit the NDA this year.

In breast cancer, ESMO, in ESMO, we reported that SKB264 in the first line, we have amazing data for breast cancer. PFS is 13 months already. We're now having a phase III study in the first line, triple negative breast cancer, and we have completed enrollment. Also for another subtype, which is ER positive, ER negative breast cancer, CDK4/6 who failed CDK4/6 treatment, we are already engaging a large phase III clinical study. Multiple pipeline has now moved from phase I to phase II. There's one bispecific, which is SKB571, which is a blockbuster for us. This is now moving to phase II on multiple indications. We have multiple phase II studies.

In the future, we also have a lot of plans for phase II studies regarding that target. As I mentioned, many of the ADC pipeline is now exploring adding the ADC on top of immunotherapy for fusion applications. In the future, we also expect a phase II study combining PD-L1 and PD-1 and also bispecific application. There's another one, SKB51A, we're expecting a bispecific ADC to be expanded in multiple phase II on multiple indications. Now when it comes to phase I program compared with last year, we also have many pipeline that move into clinical phase I. SKB107, this is actually a for advanced solid tumor for oligometastasis.

We are now in a stage of dosage expansion. Hopefully, we can actually compare with multiple, you know, other study to compare with other treatment for oligometastasis. SKB105, this is really ADC so targeting ITGB6. We are really looking for this drug to be used in combination with a bispecific PD-L1 for lung cancer and head and neck cancer and other indication. SKB1A, which is also a bispecific with PD-L1. This we hope really could be combined with our own very ADC pipeline.

We look forward to, you know, SKB105 and also TROP2 ADC. Maybe these can be forming some sort of combo ADC plus IO 2.0. SKB575, which is SKB575, which is a non-oncology drug in clinical phase. As I mentioned, you know, Livivo is just SKB378 , which is TGF-beta antibody. But this five seven five, this is actually based on this targeting TGF-beta, another type two 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 two 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 TAA tumor antigen and PD-L1. Also there's SKB565, which actually a dual payload ADC composed of a cytotoxin and a agonist. We can see our pipeline from monoclonal ADC, which is now entering a stage of bispecific dual payload ADC. Of course, we are looking forward to future of this bispecific dual payload ADC and advancement of the R&D to approval.

The next page, our CEO mentioned just now from the customer side, we are really supercharging. We have nine items in phase III, including those that are approved for testing and dosing has just started. Most of the phase I and phase III studies have been completed and now in a stage of follow-up. We need to mention that this year, you know, for the ADC, we are laying out phase II on the neoadjuvant in TNBC. Because in TNBC, we have really a lot of experience in combination for second-line phase II.

We hope to move from second line to third line, moving to second line and moving to first line. Even we can adopt the drug in a neoadjuvant therapy for some lung cancer with rare mutation. For MSD actually conducting multiple phase III study worldwide. MSD's strategy will be starting to focus on some differentiated indications, including gynecology and gynecology and tumor. You can see six item in GYN tumors. This is really for first line and also moving the second line and later line for ovarian, cervical and also the uterus.

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 in the neo-adjuvant with some phase III study. As mentioned, MSD just they're deploying this drug approval like ASCO GU. We have published the Keytruda combination on PMT. The data has been really amazing. PFS close to 12 months. As a result, MSD is engaging a phase a study for the second line. We mentioned, like this year in ASCO and ESMO, gradually we'll be reporting the data readout from large phase III clinical study.

As you can see, for second line, each of them mutated second line TKI, you know, particularly, non-small cell lung cancer are resistant to the TKI in the second line and also, non-small cell lung cancer, you know, after TKI or after chemotherapy in the third line and also for, there's some later line data readout. Actually, from this Kaplan-Meier, you can see a lot of OS data are really amazing. A lot of OS benefit are really good. Particularly, you can see the Kaplan-Meier. Long-term OS seem to have a long tail effect. This is really similar to PD-1, kind of a tailing effect. Whether the EGFR control or PD-1 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 non-small cell lung cancer, I think, in March, 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 resistant OS can still be that high. It's really worth waiting. Also the A166 for small cell lung cancer. Right now in small cell lung cancer, the competition is quite intense. The A166 is differentiated with some other pipelines because our toxin. The toxin is the only one that is targeting the microtubule, MMAF.

This is a different payload, it's different toxin. The linker design is also different. You can see the safety spectrum. Compared with many other pipelines, we are very different. We have very low instances 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 are some difference in absolute PFS because we are enrolling different population, with different history and different, you know, 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. There's a comparison with T-DM1. There's significant benefits, including the ORR as high as 87%. This is really differentiated for HR- for HER2 positive breast cancer.

Zhou Zejian
CFO, Kelun-Biotech

Okay, for my report today, I'm gonna talk about the financial performance this year. First of all, the revenue and margin. In full year 2025, the company revenue was RMB 2.06 billion. Including the revenue with the external co- partnership, cooperation, and R&D-related revenue total RMB 1.52 billion. The commercialized revenue was RMB 540 million. Total revenue increased by 6.5% compared with last year. I have to make a note here.

The commercialized revenue on 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 our NRDL price adjustment. Which means if you look at the price before the NRDL deduction, the revenue will definitely be higher than number reported on the statement. The second half revenue definitely was better than the first half. The GP margin. Gross margin, RMB 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 commercializations, you know, GM that's operated by ourselves, the gross margin will be higher than the gross margin with our co-commercialization or co-development. Therefore, the gross margin will be trending higher than revenue. GM was moving faster than the top line. Loss-wise, the total loss was RMB 380 million, which is indeed slightly higher than the previous year. The increase actually related to the financial structure. Because we have commercialization activity, there was expenses for marketing and sales. Particularly, this was the first year of commercialization.

In the first few years of the launch of 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 collaboration. 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 RMB 210 million. Now, this is the breakdown of the cost expenses. First of all, the operating cost, as I mentioned. Operating cost was RMB 580 million. The main component is because of the collaboration, the external collaboration, the R&D investment, 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, correspondingly, our commercialized product and corresponding production costs are relatively small in absolute amount. In terms of composition, the composition operating cost is mainly brought about by our investment in collaborative R&D. Regarding our R&D expenditure, last year it was RMB 1.32 billion, increased by 9.4% compared with previous year. Over the last three years, the trend of R&D expenditure is relatively stable. Quite stable, I would say. A slight increase, which is in line with the expansion our business scale. Administration expenses also the same. Last year, administrative expenses, RMB 180 million, increased by 8.6%, slight increase.

Finally, sales and distribution expenses amounting to RMB 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 of commercial revenue correspondingly in 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 RMB 6 billion, compared with previous year, it increased by 40%. In the past few years, our assets has been increasing every year, and among which the largest component is cash and financial assets.

Last year, cash and financial assets reached RMB 4.6 billion. The financial assets mainly includes 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 funding, of financing, through that placement. At the same time, the beginning of the end of last year, we also signed two new BD transactions, and 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 RMB 1.12 billion compared with asset side, the debt-to-asset ratio is very healthy. The liability mainly include accounts payable under trade items, as well as contract liability, which reflect our financial performance. Now we move on to questions and answers. We are grateful for some analysts who actually made the 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 questions online. Feel free to raise your hand. We see some hands already. Ziyi, why don't you start first? Thank you.

Ziyi Chen
Research Analyst, Goldman Sachs

Thank you. This is Chen Ziyi. Two important questions. Well, the first is for Dr. Jin .

You know, this year we care a lot about the first-line lung cancer, TPS, you know, greater than less than. I remember OptiTROP-Lung05 and OptiTROP-Lung06, two clinical trials and also the readout, the first-line TMB. So I'd like to really just confirm when this data will be available and when this data are available. The second question is 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 view the two data readout? Because for MSD, some ongoing, global phase III study for first-line lung cancer, how do you interpret the outcome and impact?

The 007 that they developed, which is also PFS above 15%. There's another file for squamous cell carcinoma, first line maintenance therapy, 023. How would the two data readout be read across? I mean, their design are really different. Dr. Wang, you just talked about you have one that is actually in combination with osimertinib. I wonder whether they will be read out this year. That would be my first question.

Yeah, as Mr. Zhou mentioned, the commercialization achieve a revenue of RMB 540 million last year. Of course, that include the price adjustment with the NRDL insurance coverage. First of all, I want to understand the price adjustment. If you restore the price adjustment, what will the number be before the price adjustment?

Also, end of year, there's a target of RMB 800 million-RMB 1 billion. If there's a gap, what's the reason causing the gap to the year beginning guidance? How would I understand it? In the current environment, particularly after the medical insurance inclusion, so how much is going to be the revenue from licensing? I want you to understand the amount of licensing and how much of the expensive R&D.

Ge Junyou
President and CEO, Kelun-Biotech

Okay, thank you. Thank you, Ziyi, for the question. I will defer the first question to Dr. Jin. Secondly, regarding the sales and the sales outlook this year and Mr. Ding, and also licensing revenue mix, Dr. Jin will start first.

Jin Xiaoping
Chief Medical Officer, Kelun-Biotech

Yeah, thank you. Those are some interesting questions.

You can see as of now, second line, third line, and even first line. We're moving to the first line, which is a bigger population. We already for TNBC male we already have PR, you know, already PFS-OS, we are looking forward, you know, to release Q4 this year on ASCO meeting. We might release that data then. For TNBC negative patient it could be for end of phase I. For MSD, it is mainly because the standard care, the Chinese SOC is different from global SOC. So actually, MSD has a phase III study with TPS above 50%. So they didn't have enrollment for patient with TPS below 50%. Maybe it's not convenient for them.

We already have two large phase III studies, so maybe they are waiting for our data readout for the phase III study. Secondly, you can see ASCO, AACR, ASCO this year. We might be reading now. The ESMO might be reading out the PFS, ORR data. Maybe there could be a combination possibility. EGFR mutation in, we talk about moving into first line, like TROP2 ADC, adding some synergies with SKB264. There's a great synergy with SKB264. We can actually enhance the overexpression. This will be the best partner for the second line.

Ding Nanchao
Chief Commercial Officer, Kelun-Biotech

In the future, we can see. In June last year, we actually completed enrollment, so we have been waiting for the follow-up data. If the data is not available, I mean, it could be a good thing because with less follow-up data, it might be difficult to predict because we're gonna have a really long PFS with the combination of chemotherapy, which will definitely be better than the chemo alone. As I mentioned, we're talking about the primary endpoint for the second phase II. So we're hopefully looking at a data readout in next year's ASCO. Okay, regarding commercialization, you know, in 2025, the TROP2 ADC, the sac-TMT, the SKB264 is already out-of-pocket. So there's some concern when payment is out-of-pocket. So in that year, we'll focus on the brand building. But actually we're already seeing excellent data, even if it's paid out-of-pocket.

With that great data, that great achievement will limit the accessibility. In 2025, we've been focusing on meeting the unmet need, unmet clinical needs. We focus on our data superiority to support out-of-pocket pricing. In actual sections, 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 patient, but also related to the strategy for our medical insurance. In our pricing strategy, we also have a patient program, 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. We have done a lot of online and offline commercial, academic meetings with high-level KOL and department coverage to introduce our product philosophy. In the first year of ADC use in China for breast cancer, we actually have some experience. For lung cancer, we were really the first in China. We are the first to try out lung cancer introduction in China. We need to really deal with the communication of AE building up their the protocol of the ADC adoption. We are really leading the world, leading China, leading world in this ADC. We've done a lot.

In 2026, what is the plan? Well, definitely we are doubling the business in the future. In terms of strategic, we actually have four important things to do. Like two drugs that have been enrolled in NRDL, two have not. How do you 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+ 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 terms of phase III, which will account for a big part of our current sales, our goal in this regard is definitely define our TGI and patients. In the second line, even though for we have A223 and 410, and those are NRDL, but we do have our data advantage. We have better data, we have better compliance, we have better safety. We are going to promote our advantage through academic promotion.

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% of our revenue. This year, we have several data readouts like gefitinib, and also the non-small cell lung cancer and GI, and also we are going to explore more oncology. Okay. Any more questions?

Jin Xiaoping
Chief Medical Officer, Kelun-Biotech

I think there's a question other people are interested in. We talk about commercialization. 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, is really from zero to one, is really starting, is a-- It take a progress.

It take a process for us to build a team and allow the team to access the market. Overall 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. Well, last year, we had three 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.

Ding Nanchao
Chief Commercial Officer, Kelun-Biotech

Yeah, just one more thing.

The most important this year, after a large scale kind of work, we're gonna focus on small scale development. I think. Well, because clearly in China, we have the Two Sessions talking about the support for innovation. We clearly feel that now that we're covered by NRDL, in less than a quarter, our 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. Yeah.

Ziyi Chen
Research Analyst, Goldman Sachs

Thank you, Mr. Ding. So he also talk about after the licensing revenue, how much was related to the R&D reimbursement?

Ding Nanchao
Chief Commercial Officer, Kelun-Biotech

Well, there's a trick here, because in terms of the co-development reimbursement, it's accounted as revenue and cost at the same time. They are not exactly corresponding because the reimbursement has its own logic. Maybe it can be based on cost, 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 the number. The cost and revenue is a great reference, but they are not exactly one-to-one ratio.

Speaker 10

Okay. Now this is Zhang Qing. I'd like to talk about commercialization. Now that you have a team of commercialization operating, now you know you should invest more in R&D and more in resources.

My question is, if you like 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 like the looking at the overseas market launch, what are the indication? Hopefully, we can see some overseas data this year.

Ge Junyou
President and CEO, Kelun-Biotech

Okay, first around breast cancer commercialization staffing and second, MSD is the overseas expectation. Now, Dr. Jin, maybe you can cover the question.

Jin Xiaoping
Chief Medical Officer, Kelun-Biotech

Thank you. In terms of indication, and indeed, we have a lot more breast cancer, lung cancer has a lot of population, so definitely we have more team member 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, you mentioned we cover 1,200 hospitals in non-NRDL provinces, and this year we're gonna double the coverage with NRDL inclusion. We're gonna cover all the tertiary hospital from commercial, municipal, and county level. We still want to bundle some of the team in some of the hospitals, but we're gonna separate breast cancer and lung cancer for key hospital, key province, and key cities.

Yeah, thank you. When it come to the, actually, for indication, I think, we're looking forward to the indication approval this year.

Main strategy is to be combined with pembrolizumab in the first line, even earlier for neo-adjuvant therapy. It will take some time because it will take time for enrollment and follow-up. The first indication should be endometrial carcinoma. Okay, thank you.

Speaker 11

Okay, this is Olobi Olobi. Thank you for having me. My first question for Dr. Ding about sales. I mean, the three products are now listed for NRDL. This year you want to double the sales for SKB264, but what about sales guidance for A140, A166 or KL-A167? Second question, you know, Dr. Jin talked about the PFS data for PD-L1 positive patients to be read out in ESMO, and the negative patients are also ESMO. So Dr.

Dr. Jin, other than ASCO and ESMO, what other data could be read out this year? Dr. Zhou, Mr. Zhou, can you talk about the revenue from MSD? If there is a potential BLA, what is the potential milestone payment from MSD? Okay. First, other than SKB264, what about other sales guideline for other drugs? ASCO, ESMO, what about other data readout, Dr. Jin?

Ding Nanchao
Chief Commercial Officer, Kelun-Biotech

Okay. The few product they are now NRDL cover. A140 will 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 one from China. Our product safety and efficacy has been well received by the market. We also have a benefit in some repricing at China compared with the original.

This is a very mature product, so we can actually ramp up really quickly after, you know, market hospital listing. That's our A140. For A166, I think this is still, it is still a non-NRDL, and also you can see the respiratory medicine is a crowded space. We want to price ourselves differently. The A166, I mean, we are outstanding in terms of HR, AE toxicity, but we want to differentiate versus 8215. Next year, we want to really, you know, 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 821, we can actually use it before or after. Now for the drug 117, you know, indeed there's a lot of product of immunology in China. After NRDL inclusion, we want to explore combination therapy.

Jin Xiaoping
Chief Medical Officer, Kelun-Biotech

Thank you. For the data, ESMO is a bit early. ESMO will be in October. We are just still planning on this. There are a few things. We still have a lot to do. For example, for phase III, I think when the plan mature, we're gonna read out the data. This is one thing we're still planning. Of course, that depends on the progress in the phase III study. As mentioned, for PD-L1 negative, we expect to announce the results at the Istanbul meeting, including the first line TMB.

We need to see the timeline there because there are a lot still. We still need to wait the result that 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 500 pipelines. Some of the pipeline we might want to go to phase III, or maybe we could come up with readout phase II data to be presented on ASCO, but depends on whether, you know, we can conclude that before ASCO.

Zhou Zejian
CFO, Kelun-Biotech

In terms of milestone this year, we have some R&D collaborative income. We explain that this revenue on the book is not one-to-one correspondent to the receiving of the payment, because there are some in terms of accounting treatment. There are, it could be staggered because there are requirements of accounting principle for installment recognition according to the standards. Precisely because the pipeline, they are triggering some milestones, and it's all going to be staggered. Therefore, you can see the statement in the past three years in terms of recognition of the revenue from collaborations is very stable, quite stable over the last three years. This year we're gonna have some more pipeline to trigger milestone payment, and they will be recognized accordingly based on the accounting principles. For SKB264, you mentioned SKB264, we just talked about, there's upstream with the milestone.

Total amount is $1.5 billion. We have been disclosing the payment received. Up to now, actually we are receiving about $200 million-$300 million so far, if you don't account for the reimbursement, right? Actually the majority will be received in the future, as Dr. Jin mentioned. Particularly you talk about the voucher and so after it was approved to be listed in the U.S., it will trigger several income development milestone and also the second commercial milestone when you get to a certain commercial sales is by different gradients, right? Development milestone, followed by commercial milestone, and then thirdly, there's a sales royalty. It's really a royalty, a sales commission. A certain percentage will be taken from every product it sells.

This percentage is also tiered, which is segment by different stages. The higher the income, the higher the percentage of commission we got. We have make a disclosure of this before. Overall speaking, the corporation income will be contributing greater and greater contribution as the pipeline become more mature, as our corporation making more contributions.

Speaker 12

Okay. First of all, congratulations. We're very happy to see we have more phase I, phase II, more earlier pipeline. Congratulations. My question is, in phase I, phase II, and even earlier pipelines, what are more priorities? What are the high priorities? I mean, is it bispecific ADC or non-oncologies? My second question is about the PD-L1 monoclonal antibodies, because you can see now you have PD-L1 EGFR, EGF. Now you can see people really like the combo PD-L1, EGFR.

With such a second generation bispecific, like second generation IO plus ADC. 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, I mean, this is quite specific, PD-L1, EGFR, and the data in ADC, particularly from China. How would MNC interpret your data for you? What is the impact from last and now, some of the ADC assets?

Zhou Zejian
CFO, Kelun-Biotech

Thank you. Thank you for the question. First of all, the assets, priorities for phase I, phase II early assets. Dr. Jin, maybe you can take this, and 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?

Jin Xiaoping
Chief Medical Officer, Kelun-Biotech

Well, you talk about earlier pipelines. It's difficult to say any priority because this 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 SKB571. They are really addressing different targets for different tumor antigens. You can see the SKB103, which is a TA and PD-L1 bispecific, is actually targeting, you know, the tumor antigens combined with immuno PD-L1. So actually we hope the bispecific, they can enrich the tumor microenvironment, enhancing, improving the tumor environment. Then we talk about the bispecific. Exactly, a bispecific is a agonist plus a cytotoxin. So 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 one will carry more priority. You can see our important pipeline. We have TSLP bispecific, and also TGF-beta antibody. Our half-life is actually 60+ days. You can have a dosing every six months. With TSLP in combination, it can actually have great synergies. In fact, in terms of efficacy, it would be better than PD-L1. It's difficult to say which pipeline will be more prioritized. We want to drive them together. Either they are best-in-class or first-in-class, we want to be more flexible, maybe more flexible combination with ADC.

Okay, the second question related to PD-L1 or ADC. I mean, you are doing clinical study in China.

Ge Junyou
President and CEO, Kelun-Biotech

You are thinking about implications for global implications. I don't think I need to answer the question because a global MNC, they are more and more receptive for the early data from China.

Jin Xiaoping
Chief Medical Officer, Kelun-Biotech

You can say MSD. MSD, they have 17 clinical studies, 17 phase III trials. I mean, they don't have the early stage data anymore. I mean, whether it's gynecology, urology, lung cancer, they are doing phase III studies. They don't have early data already. They use our early data. They use our early clinical data. You know, you can gradually in the SGO, which is a gynecology congress and reporting data, the data reports are all actually all coming from us, from our phase II data. This is helping the global study, including MSD.

MSD, they are doing study like ADC trial two, which is combining with Canada. Actually, they are doing phase III study. Actually, much data are actually coming from China. So I think that's the question, is like people are now getting used to Chinese early stage data because we have patient resource in China. We have the advantage of doing clinical trials in China. We have great investigators in China. Many investigators in China are international. So MNCs are happy to take Chinese data. Of course, we also want the MNCs to do global phase III study.

Speaker 12

Well, actually, I didn't make myself clear. I want to clarify my question. I mean, for every PD-L1 EGFR, I mean, every PD-L1 EGFR are different. You are getting a very new molecule, so you actually have the new data in China.

How would this Chinese data help the MNC to believe that your ADC in a combo—I mean, how would they be compelled to use our ADC in a combo with their molecules? I mean, if they're using their own drug, can the combo produce the same result?

Jin Xiaoping
Chief Medical Officer, Kelun-Biotech

Okay. Yeah. That's a great question. You can see the 11A molecular structure. You can see what's the purpose. We're interested in this molecule based on the reason the MNC is interested in buying the molecule, because this is very similar to their molecule. I believe you know, in this traveling structure, which is based on PDB, our molecule is very common to this common one.

This is why we're confident that we can accelerate development of the ADC with a flexible PDB structure. Our ADC, whether using combo with our own pipeline or with other, you know, pipeline, we're confident. But of course, we are 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 risks. Not all the PD-L1 EGFR are the same. Not all the ADC are the same. The same thing, 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.

Speaker 13

Yeah. Thank you. Thank you. I have a question for Mr. Ge.

Ge Junyou
President and CEO, Kelun-Biotech

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 IMD, every molecule is actually looking at OptiDC. We have done a lot of comparison, horizontal and vertical comparison. We have high hope for every pipeline. Of course, it's based on risks and data finally. It may not succeed, but at least in early stage, we do more work and to drive it and to make a chance to move into clinical. Every pipeline is something that we take a lot of, you know, pride in. We are very prioritizing every pipeline. We hope they can be drugable.

Speaker 13

The second question for PD-L1 VEGF—PD-L1 VEGFR, I think it is a very hot topic, a very hot target. But can you really develop PD-L1 VEGFR interface? Also, can you demonstrate better efficacy compared with single target IO?

Ge Junyou
President and CEO, Kelun-Biotech

Right now, we don't know. We don't know whether combination is better than monotherapy. It's something we need to explore. But at least from right now, PD-L1 VEGFR in synergies with ADC, I think people really have high hope. People really believe that it's gonna be successful, very likely it will be successful, that combination is better than monotherapy. How we use the data in the future? First of all, our partners.

I hope our partner will use our data in combination because they only get the rights in China, they can license the rights for outside China, they can use it. So 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.

Speaker 14

Thank you. Thank you for having me. Two quick questions. Trying to understand your internationalization strategy. I mean, many companies, large and small, they are looking outside of China. They are. So my question is, mid- to short- to long-term, what's your strategy for internationalization?

Second question, we have a lot of AI application in China, in the world, many company using AI. So is your company doing anything in AI?

Operator

The first question on internationalization, Mr. Ge, you can take this. The second question, the use of AI, Dr. Song and also Dr. Yu, they can talk about the use of AI. Mr. Ge, you can. Can you start first?

Ge Junyou
President and CEO, Kelun-Biotech

Thank you. International strategy, as I mentioned in the last slide on my PowerPoint. We position ourselves to be aiming or aspiring to be an international company. We have a clear pathway. First of all, we are working with MNCs and series of international partnership to build the international R&D and development capability. As I mentioned, in our cooperation with MSD, in our cooperation, they need our early-stage clinical.

Many international multi-center is done by Kelun, done by us, done by our team. They can use our team to go to FDA to register phase III clinical trials. We're building our team and building our capabilities.

Operator

Apologies, there are some audio issues from the conference room.

Song Li
VP of Small Molecule R&D, Kelun-Biotech

Well, when it comes to AI application, I think we are not just doing it for the last two years. If you trace back, we've been doing this for quite a long time. Back when AI was not so trendy yet, like, even in red notes, you know, we are recruiting an experienced director to build our platform. When AI started to be popular, we are already using AI application in our departments.

As you know, AI is mostly used in the front end of pharmaceutical R&D, and we're just gradually building the maturity. So 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 example in small molecule platform. Now we have AI to distinguish. We're 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? You know, 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, biomedicine tests, a lot of data is in our database. We have our own model, which is a great way to use our data. 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 very helpful.

Back to your small molecule, it's even more simple because we make a good achievement in small molecule because small molecule R&D is less difficult, but it's a very significant overlap in patent overlap. If you only optimize the structure of a known structure, you are very likely to be hit by a patent risk. Now we have AI, we have abandoned the model. We actually start from molecule with brand-new structures. In some biology, genotype determine phenotypes. Actually, your advantage come from the molecular structure, so you can actually sense the help from AI to R&D. Back to ADC, so 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 translation of 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. In biomarker, actually AI helps with a lot of promotion, and also large molecule as well. In antibody optimization bispecific, we are feeling really if we have not been using AI a 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 , anything that you want to add to this?

Tan Xiangyang
Chief Scientific Officer for Biologics, Kelun-Biotech

Let me just add a couple of 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. We are building a cooperative, collaborative relations with many companies. AI is now being used in Kelun-Biotech in a few ways. First of all, AI helps to improve the quality of our projects. 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 two regards, several projects have really benefit from AIs.

Of course, when it comes to ADC, it can help us to predict the payload linker pro-property and the drug ability of small molecule, and AI also help us with the challenge in terms of the synthesis SAR. So all these are where AI can play a role.

Operator

Thank you. Matthew. Matthew?

Speaker 15

Yeah. Thank you. This is Matthew from. My question is about the phase II clinical C1O. Some time ago, MSD also have a phase II. So what is your expectation in the coming year of read out compared with assets, compared with Astellas to asset, how is it different from the Astellas? The second question is, the STING in the pipeline has removed A296. What's the consideration? Now, first of all, thank you. Can you respond?

Ge Junyou
President and CEO, Kelun-Biotech

I mean, regarding this question, the first question, we licensed the global application to MSD entirely. Secondly, the STING. Because this is a small molecule. Yeah. As I mentioned, we licensed to MSD. MSD is doing this global development. It started out with domestic development. After getting the molecule, MSD might want to do some technical transfer, so it may take a bit of time. Phase I, phase II in China, and then they're gonna do global trials. So it takes some time for technical transfer. Right now it's actually going on very well. They have launched some phase II study on multiple indications. Compared with Astellas EV, it is mainly targeting topoisomerase. The molecule similar to SKB264 ADC had the same payload and linker.

With the success of SKB264, we are very confident in the molecule. Also, the molecule is very different from EV, because EV is a MMAE drug. MMAE, you know, has a lot of side effects and toxicity in dermatology, neurotoxicity. But our molecule, you know, and the molecule can cross a blood-brain barrier. We have tried ADC through the SKB264, and the data has been amazing. We hope, in the future, we can have good target for cervical cancer, breast cancer. Also EV, compared with EV, we really have a different payload toxin, which means it's easy to break through into new indications. Now, the second question on STING, the small molecule. Yeah. Actually this molecule is one that I've been trying in early stage.

Right now you can see, well, actually they also remove, 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 good results. This is why we're not spending too much effort on this. Also on SKB565, is a. You know, they also have the 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 Toll or STING, this is the first ever attempt.

You're not promoting it to clinical trial. It doesn't mean we have stopped the pipeline R&D. We continue to build data. I mean, we continue to build data from R&D, the clinical and iteration. You can see our data and our Toll-like receptor molecule and other small molecule and other isoform with those as target. They're actually using antibody with this immune agonist. By building this data, we now understand that immune agonist, a single target, the druggability is limited. It's difficult to strike the right balance between efficacy and safety. 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, it's difficult to get the PK or PD.

Because if you have efficacy, you're gonna have immune activation. Whether it's a small molecule or ADC, you know, 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 need a partner. They need a partner to act. It itself mainly act to activate immunity. Then there's another molecule, another mechanism. This is why we follow up with the 515, as Dr. Jin said. We have the immune agonist combined as a dual payload with the cytotoxin. With dual payload, we are actually researching on the combination mechanism. We wanna 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 durability, durable efficacy.

Operator

Well, maybe we can take final two questions. Maybe Wang Shu Yu.

Speaker 16

Just a question on the financial statement. Price adjustment, you talk about what's on the inventory. So for whatever in your stock, it's already priced based on the adjusted reimbursement price. And also, would the expenses be recorded in the sales expenses when you're cooperating with the pharma? Well, these are two questions.

Zhou Zejian
CFO, Kelun-Biotech

Yeah. We are working with pharma. As mentioned, A140, we should make announcement for A140. Clearly, we have a CSO model for A140. We're gonna commission a pharma. Like, A140 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 A140. Any revenue generation, it will be booked to Kelun-Biotech. But we also book the corresponding expenses. The expenses will include the payment to sales services, promotion services. From Kelun-Biotech, the revenues and expenses are all recorded here on our own company.

Okay, now to the online audience.

Speaker 17

Okay, thank you. Thank you for having me. I have two follow-up questions. The first question is, you can see this year ASCO will read out a PD-L1 positive data. Do you split the cohort between squamous cell and adenocarcinoma? Because MSD, in their indication, they'll split between squamous cell versus adenocarcinoma.

I wanna know whether the TROP2 ADCs cohort will be differentiated. My second question is, last year in HR positive, HER2 negative breast cancer, there was a PFS result, which is amazing. Also a beneficial trend of OS improvement. I want to know, is there any more data regarding the update of OS maturity? Because in AstraZeneca OS is not significantly better than the control group, which really compromised themselves. I just wanted to know, do you have any update?

Ge Junyou
President and CEO, Kelun-Biotech

Yeah. Two detailed clinical question, Dr. Jin.

Jin Xiaoping
Chief Medical Officer, Kelun-Biotech

First question. Yeah, indeed, we're gonna record both squamous cell and adenocarcinoma. Those will be data readout accordingly. Secondly, kind of to HER2 negative. Yeah, indeed, for indication, NMPA has been, it 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 next year's ASCO, we might be able to have final OS data. There are more and more drug coming on, including like A201, 1811 from China. A lot of patients will be using this type of drug and also subsequent new OS. We're gonna see some OS improvement. As I mentioned, we are very confident in our TROP2 OS benefit because in terms of lung cancer, the subsequent treatment for OS is a bit less, so lung cancer should produce great figure. We are having positive results in the OptiTROP in OS.

Zhou Zejian
CFO, Kelun-Biotech

Yeah, we are significantly behind schedule. I will run a little overtime. I know you still have many questions, but going forward, we're gonna go to Hong Kong. We're gonna have some offline communication, our roadshow in other cities. So if you have further questions, feel free to join our offline roadshows. Mr. Ge, can you wrap up?

Ge Junyou
President and CEO, Kelun-Biotech

Yeah, I think you have summed it up. Pretty much I'd like just to 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 very much.

Powered by