Thank you, investors, for taking the time to the Kelun-Biotech 2026 interim results presentation. Today, I am going to talk about four parts. I will start with the business overview. I will be taking over the overview, followed by China's commercialization, which will be presented by Mr. Ding, Nanchao. Clinical development progress and strategy, which will be presented by Dr. Jin, Xiaoping. Finally, CFO will present financial and business performance. Let me briefly go through the business progress. I think you know this slide very well. Kelun-Biotech is a company that is dedicated to oncology, metabolism, as well as other therapeutic disease. The controlling shareholder is Kelun. Second largest main partner is MSD. From the profile, you can see we have 30 pipeline assets, including four products with eight indications approved for launch.
Then we have three NDA submission, which is in the process involving two products. We have 10 + pipeline projects in the clinical stage. As of the 30th of June, Kelun-Biotech, we employs 2,300, including 900 R&D, as well as 550 production and quality management. The new commercialization team is now over 800. I will take a moment to talk about the business strategy of the company. Firstly, we have established a complete system from R&D development production to commercialization. In terms of R&D stage, we have three major platforms. If you notice, you know the ADC, which is the drug conjugate platform. We have antibody, monoclonal antibody, bispecific, and large molecule, and small molecule R&D platforms. Over the years, as you know, with the use of AI, particularly in development of innovative drugs, AI is being widely used, increasingly more common.
Over the time, Kelun-Biotech has integrated AI in our R&D process, enhance the efficiency of research. In production segment, we have the complete system from antibody, small molecule, to conjugate and formulation. We have a complete suite of manufacturing capability. At the same time, the quality system in a half year in the past has been inspected multiple times by the National Medical Products Administration, QP certification from the European Union, as well as our international partner who conduct the onsite audits. They have all endorsed our quality system. Of course, importantly, this is about commercialization. This is our first year for commercialization. Multiple product has been covered by medical reimbursement, so this is in line with our expectation. Later on, Mr. Ding, Nanchao will talk more about the commercialization. Secondly, I am going to talk about international collaboration.
Whether it is a large molecule, small molecule, or ADC projects, have been working with multiple MNCs with BDs. Of course, most importantly, the partner is MSD, where we have multiple ADC product being developed in collaboration. Like the sac-TMT, which is the TROP2 ADC. We have 17 phase III clinical studies ongoing. The very first project for EC, which is a phase III clinical study, we have already announced a positive results, both positive results in PFS and OS. MSD recently was going to file for listing approval from FDA. Other ADC is also ongoing in clinical collaboration. In the past year, another progress was ADC, which has SKB105, which is where we license Crescent. Crescent is also conducting the global clinical study worldwide now.
Now, through the international collaboration, we are expanding and helping us to enhance our clinical study outside of China as well as the overall registration, regulation, communication, which has helped us to build our capability and also accumulated experience for going global, which has built a foundation for our future globalization and global expansion. I am going to spend three slides on the product pipeline strategy, starting with the oncology-related product pipelines, particularly the conjugate drug technology. This in clinical stage we have 315, 571, 410, and we also have two approved projects, which is the sac-TMT ADC, and also the trastuzumab botidotin, which has been approved for launch. Also in clinical stage, we also conducted the preclinical study, which includes the drug conjugate. Those are in three groups.
The first group is what we call the single-payload, new type of ADC, which include the RDC with the nuclei RDC, and also drugs that with the payload of immune agonist and payload, such as these drugs. Also you are also interested with the degrader, which is synthesized as a new cytotoxin payload. The second group is what we call the dual payload drug conjugates. Dual payloads includes the cytotoxin plus cytotoxin. So two toxins combined. It could be a different type of toxin and also dual payload with the immune agonist plus cytotoxin. So you can see the 565, which is now in clinical stage. We are also developing the protein degrader plus toxin as dual payload, and DDR inhibitor plus toxin conjugate.
The third category is what we call the targeted drugs, based on what we call TA, tumor antigen targets with some immune or anti-antigenic mechanisms such antibody and small molecule payload, with the polypeptide conjugate drugs are also on development. The second type in the second slide, this is in our pipeline strategy. You can clearly see from monotherapy to combination. This is very important strategy, from monotherapy to combined therapy to later line to frontline. This is a combined ADC with RO. This type of synergistic therapy based on different anti-tumor mechanisms by combination, it can better overcome the tumor heterogeneity, and also hopefully will overcome the drug resistance. So this is really important in our development strategy. We developed the ADC plus PD-L1, where the PD-L1 combined with pembrolizumab.
We can see the first PD-L1 positive results has been read out in the phase III clinical study, and NDA has been submitted. At the same time for PD-L1 negative and non-small cell lung cancer in phase III, which also reached our main endpoint in the study. So this is [Waqueras]. Also we have other phase III clinical trials working with our global partner, MSD. They are conducting a study on breast cancer, lung cancer, as well as the gynecological tumors, endometrial cancers. Also other ADC drugs like SKB315, SKB571. You can see SKB500/SKB510 has already entered phase II clinical trial. The second type is about combination therapy, PD-1 and PD-L1 combination, and we also bring in PD-1 with PD-1 VEGF combination, which is called SKB118.
So recently for sac-TMT combination, we also have a phase II clinical study where we have just received approval from the national authority from July, and now we are enrolling, recruiting into the study. At the same time, in the future, we are going to explore new indication with combination therapies. For the 11A, which is a bispecific, will also be combined with other ADC, and we will explore the combination of those drugs. So those are what we talk about the combination therapy. As a combination therapeutic synergy, there is also important strategy, which is what we call integrated development, immunotherapy and ADC, to be made into one molecule. So there are two directions. First of all, on the target side, we combine the target with the oncology with an immunotarget, which you can see in SKB-D103 project.
That was how we combine two targets, one on oncology, the other on immunology. Also the SKB565 project that we mentioned, which is a different mechanism. So one antibody, with the conjugation, with different toxins, with dual toxins. However, the toxin is also payload with immunoagitation. So this is also in the preclinical discussion and also in the preclinical strategy also as part of the integration strategy, which is also from the conjugate strategy. Thirdly, the pipeline on the non-oncology projects and the non-oncology projects is also in clinical study. Representatively is the SKB378, which is now in phase II and phase III study. Our overseas equity has been licensed to the Avivo Bio. So that company is now conducting the phase II global study on COPD, and they have completed the first group of patient enrollment, and the first group of patient has been dosed, actually.
They have phase II, phase III study for asthma. They also completed dose exploration. So SKB575, which is a dual-target non-oncology product, is actually for atopic dermatitis and asthma. The IND has been approved in China. It is now conducting phase I clinical study. At the same time, for the conjugate technology, we are also exploring the drug conjugate in non-oncology indications, with the non-cytotoxin payload, and also using the drug conjugation technology. It is now being developed. Soon, it is going to move into clinical phase. So those are the pipelines. Now, briefly to talk about in the first half, some of the achievement that we make. So first of all, the pipeline, and then commercialization and financing. For commercialization and financing, Mr. Ding, Nanchao and Mr. Zhou, Zejian is going to report further. I am going to talk about clinical progress.
First of all, in February, in the second line, ER-positive, HER2-negative breast cancer has been approved for launch in China. At the same time, in NDA phase, the sac-TMT for first-line triple-negative breast cancer and first-line PD-L1-positive small lung cell cancer were also reviewed for new indication. Of course, we also have a series of new phase III clinical trial underway with results for key endpoint already available, which include other clinical strategies where Dr. Wang Jingyi will further present to you. In terms of commercialization, I want to present to you an important point, that this year, this is early August 2026, so in terms of the national insurance negotiation, which is intensely underway, you can see the sac-TMT for three indications, including what we have approved which is A166. The trastuzumab botidotin, that has approved the medical insurance form review.
Also, we are now involved in the reimbursement negotiation. For other commercialization, Mr. Ding will comment further. Now let me talk about in the first half of 2026, in terms of academic publication, you can see, first of all, on ASCO, we have two oral presentations. This is about registration clinical study with two oral presentations, sac-TMT for PD-L1-positive NSCLC. The other was on the A400, which is the lunbotinib registration study for the RET NSCLC. Also in ELCC, we also have a phase III lung cancer study for EGFR mutant lung cancer. Also we have a range of phase II clinical study to be reported on ASCO, academic journal, like Cancer Cell, or JCO. Of course, we also have publications simultaneously in The Lancet. I am going to briefly report to you Kelun-Biotech's overall strategy as a company and the future outlook.
First of all, we will continue to promote differentiated innovation to meet the unmet needs. Also innovation pipeline will be continued to innovate on the ADC platform, whether it is a new linker, new strategy or the new cytotoxin or the new conjugation technology in terms of the structure of the ADC. Also, we are going to expand to the non-mainstream area. Also we will continue to expand and consolidate our end-to-end development capability, particularly commercialization. The commercialization capability will be further enhanced. Also in terms of global strategic partnership, we will continue to optimize the system to build a company in the world's leading biopharmaceutical company. Now I would like to have Mr. Nanchao to talk about commercialization.
Can you hear me clearly?
Yes, loud and clear.
Okay, good evening. I am going to talk about the first half of 2026 in terms of the progress and commercialization.
You can see up to now, we have four products successfully commercialized and launched. Later this year or early next year, the first small molecule product, A400, will also be launched. So in the first half of the year, the overall product revenue reached RMB 765 million with a year-on-year increase of 112%. If we were to look at the business growth, I think we can take two angles. First of all, we should look at the excellent data and how the experts has been endorsing the high-quality clinical data, and the growth from change of therapeutic philosophy. We have multiple globally leading high-quality clinical study, which has been read out, and they have been published in important academic congress and journals, further enhancing the evidence and also helping the product.
For example, our clinical evidence has also expanded from EGFR mutated NSCLC on the third line and expanding to the driver gene negative NSCLC in the first line. So, this also presenting the excellent competitive efficacy and clinical value for our product. With the presentation of high-quality data, our innovative product also gained more endorsement from experts, and we have been included in the multiple guideline and expert consensus in the country. At the same time, we continue to engage high-quality medical education academic exchanges so that clinicians understand more about the product mechanism, efficacy, safety, and indication. Continue to help to convert people's treatment philosophy and further enhancing the confidence for physician to adopt the innovative therapy. The most important products in the lung cancer, we have established ourselves as a standard in a second line and preferred product for the third line.
TNBC, we also have the preferred brand for TROP2 ADC in triple-negative breast cancer. With a high-quality evidence and expert endorsement, guidelines recommendation, and clinical practice, we are forming a virtual cycle, continue to accelerate the value and also providing benefit to the patient and also build a foundation for commercialization ramp-up. Secondly, the growth perspective is really from the market access policy and the change of the access environment. With higher accessibility of the product, the growth also come from higher accessibility. Now we have three products, commercialized product with five indication being covered by medical insurance. You can see Jiatailai. This is the intrathecal monotherapy pump in the catalog. The only one used to treat TNBC and NSCLC as a domestic ADC. With that kind of access policy, we greatly enhance the accessibility to patients.
We are also promoting the doctor's prescription motivation and the convenience for patients' medication. This is really enhancing the experience. At the same time, other than indication, Mr. Ge has mentioned, we have two new indication. The second-line NSCLC and also the HER2-positive, sorry, HER2-positive, HER2-negative second line, and also the T-ADC, which has been reviewed to be commercialized next year. With the access policy, it is also making hospital available to us. In the first half of the year, we quickly got coverage for reimbursement, so we have been able to be listed into the hospital temporary procurement and due channels. We are entitled to multiple channel for medical reimbursement. So the patients are finding our product more accessible, and they enjoy medical reimbursement. So we cover multiple province in China. We quickly convert the reimbursement value.
Now we operate in 30 provinces, 300 cities, and 2,000 hospitals where we have full coverage. So much work require bigger team. In the first half of 2026, we almost doubled the headcount of the commercialization team. Earlier on, we built our different supporting roles, medical marketing roles. However, in terms of sales team, we doubled the headcount this year. Also we are improving the capability build-up of different functional roles and different functional departments, and we are able to cover more provinces in the second-tier regions. As we cover more and more top hospitals, we are now covering more secondary county-level hospitals so that we are able to enhance our coverage in China. Also we completed registration of medical reps to do it compliantly.
Thirdly, in the future, with the indication rolled out and the product promotion, I think in lung cancer, we look at the mutated patient to drive the penetration of our ADC in mutant population. In the first half, we already achieved reimbursement to cover the third line mutated patient, and also we focus on the benefit in PFS and OS, and also we have the medical reimbursement. This is really achieving outstanding advantage as a monotherapy. Now, going forward, we are going to go to second line in the mutated population, expand in the mutated population in the second line. Over longer term, I think sac-TMT is going to go for non-mutated population, particularly in the first line, which is a bigger population group.
I believe the launch of indication next year, this is going to be very important for sac-TMT to become the dominant players in lung cancer, and also can be a leader in breast cancer. We will continue to drive the adoption of ADC in the advanced TNBC and breast cancer overall. We are going to focus on enhancing the role of IVDC. We want to switch from traditional regimen to innovative regimen. At the same time, sac-TMT is also going to be highlighting its differentiation with other categories in terms of target indication and payload differences and safety differences, so that we can highlight our clinical advantage, so we can provide more option to patients. I think we already got reimbursement for second line, and next year we are going to drive the triple-gene negative population, which is a greater population. This will produce significant clinical benefits.
Also, we are going to gain market share. Of course, other than the blockbuster sac-TMT, in the first half, another product, which is the Cetuximab N01, will also make very good progress in cetuximab. First of all, it has been covered by reimbursement catalog. With the product, it is really the first one in the world to have completed a head-to-head, large-scale phase III study to achieve the clinical efficacy verification. So we also set a very competitive price so we can quickly capture market share. In the first half, we have market coverage of 1,100 hospital in the country. Compared with the original drug, our cetuximab has a better value for money. Compared with the domestic competition, we have better indication. So we have more expanded indications to meet the needs.
So with the reimbursement benefits, with more coverage of the hospital, the Cetuximab N01 is going to achieve greater potential. Particularly in the incidence of the colorectal cancer, in China, CRC is high in terms of incidence. Also with the standards of treatment of the biomarker testing from CRC, this will further enhance the genetic testing rate for CRC and each of our category will be further expanded. Thank you. Dr. Jin, can I ask you to talk about the clinical progress?
The investors, good evening. I will just spend a few minutes to talk about the clinical progress a year today in 2026. I will leave more time for Q&A. Overall speaking, in terms of clinical progress, can be divided into four areas.
First of all, if you look at the core product, sac-TMT, has to be moving from later line to first line, and from the Chinese, and also being promoted to the world. Also the next generation ADC, I will talk about SKB500, SKB571, and A400. So they are forming a new value curve. At the same time, the OptiDC platform is also moving from traditional ADC, which is a traditional ADC, to DU antibody ADC, DU payload ADC, and also ADC is also combined with a new IO 2.0, which is PD-L1 and VEGF. In that regard, the non-oncology SKB575, we have achieved clinical study in the phase I on healthy subjects. In terms of dermatitis, asthma, we are also conducting phase I, phase II study on atopic dermatitis and asthma.
Now, when it comes to sac-TMT, which is the core product, it's been mentioned in February. It's been approved in the indication for breast cancer for HR-positive, HER2-negative. In the first half of the year, it's also approved for first-line TNBC. It's also got a positive result in the first-line TNBC. We have submitted the NDA. We got a preferential review, and also presented in the ASCO this year. Next slide. In this year's ASCO, we reported a heavyweight phase III study for each of our [Y-type PD-L1 positive patients. You can see the hazard ratio was 0.35. Particularly, for TPS above 50%, PD-1 high expression, the hazard ratio was 0.47. Whether it's a PD-1, 1- 49 or PD-L1 high expression, we have achieved excellent PFS benefit. Of course, we have seen excellent trend of benefit in OS.
The OS reached 0.55. In July this year, we have announced that in another large phase III study, which is for each of our triple-gene negative, PD-L1 negative, NSCLC, we have achieved excellent positive result, PFS positive, and OS also show a trend of benefit. We plan to report the phase III result on ESMO this year. The sac-TMT, whether it's a PD-L1 negative or PD-L1 positive patient, we cover them all. This goes to prove ADC, TROP2 ADC sac-TMT, can become a backbone therapy to replace chemotherapy, and also combined with immunotherapy. On this slide I'd like to focus. The last line. I like to just emphasize that going forward, most importantly, on the sac-TMT, with the flexible IO 2.0, V1, V2, V3 development. In the lung cancer, we have started phase III study.
We already have patient enroll, and subsequently, we are going to explore on other solid tumors with the sac-TMT. Also, we want to combine sac-TMT with immunotherapy, with the PD-L1, and also hope our phase II study can be shared with MSD. MSD could conduct more sac-TMT combined with PD-1 and VEGF. Like the SKB264 combined with PD-1 to replicate that success. I'd like to emphasize, as mentioned, in Europe, the Lung Cancer Congress, we have reported the OS results. The sac-TMT on the third-line population who fail TKI and fail the dual anti-VEGF treatment. The mean OS, we have achieved 20 months of mean OS and hazard ratio considering the crossover, the hazard ratio of sac-TMT was 0.45, which is very good survival benefit on the OS, which also proves sac-TMT provide long-term survival benefit. Finally, let me talk about A400.
A400 is. Actually presented by Professor Wu Yilong on ESMO meeting. We look forward to be a second generation or next generation RET inhibitor. In term safety efficacy, this generation of RET inhibitor has demonstrated excellent efficacy. The PFS in the later line population, the mean PFS was 27.5 months. In the first line, untreated first line PFS will be over 30 months, which is a very nice efficacious result. And safety is also very good. We look forward to what Mr. Ding was talking about, the commercialization of A400 as a product. Finally, just a summary of the clinical progress. We have make a lot of progress in clinical studies. The sac-TMT has been now into use in the first line. MSD has got a positive result in a global study.
Now going forward to A400, SKB500, SKB571, they also got pretty good results in phase II study. Please stay tuned in the ESMO, where we are going to present the results of SKB106, and MSD will report the 05 and 03 results as last phase III clinical studies in the second half of the year. With that, thank you.
Thank you, Dr. Jin. Finally, just a few minutes on the financial performance of the first year, for the first half of the year. First, the revenue profit. In the first half, the overall revenue was RMB 978 million. Compared with last year, it was kind of stable versus last year, but there is a big change in the revenue mix. The commercialization revenue in the first half contributed RMB 657 million, which is over 100% compared with last year.
You can see as the commercialization activity getting deeper and deeper, we can expect the commercialization revenue to make even greater contribution to the overall revenue. GP margin was 7.36%. Sorry, RMB 736 million gross margin. We achieved profit in the first half of RMB 388 million. The profit was benefiting from the settlement-related collection of the first half of the year. If we exclude some of the non-recurrent income incentive operation, the adjusted profit should be RMB 479 million. Regarding cost expenses, the cost of operation was RMB 241 million in the first half. In terms of month, it was down by 16.9% year-on-year. The COGS was actually higher accordingly. This has to do with the higher drug sales in the year and also other R&D-related costs, which is a part of the cost, including employee costs and related experimental trial expenses. Those has been decreasing.
This is actually consistent with the trend of overall collaborative income. In terms of R&D expenses, RMB 768 million, increased by 25.7% year-on-year. Dr. Jin mentioned this year, we will have more clinical studies this year, so R&D expenses has been slightly higher. Administrative expenses was stable, RMB 79 million. The sales and distribution expenses, RMB 390 million, compared with the same period last year, there was an increase, which is consistent with the higher commercialization revenue. Finally, about asset liability, as of June 30th of the year, the total assets was RMB 6.322 billion. Compared with last year, it was increased by 5.56%. The main composition of assets were the cash and financial assets. Cash and financial assets total RMB 4.783 billion. Liability at June the 30th, it was RMB 985 million compared with last year, same period last year, it was decreased by 12.18%.
The asset liability ratio is around 15%, which is very healthy. With that is the financial performance. Now we are going to take questions. As you can see, we have a lot of analysts who come a long way, and also we have online audience. You are also welcome to ask question from the online channel. Let us start with taking question in the room. Maybe lady first. Thank you.
Thank you, management. Indeed, we are very impressed by the data, particularly the disclosed data from SKB264. It was really amazing data. You can see SKB264 in all the lung cancer clinical studies, in China or outside China, all the clinical trial has got excellent results. As you understand, including SKB264, there are quite a lot TROP2 ADC, they have conducted the first line combination with the pembrolizumab in the first line. So they all achieve good results combined with pembrolizumab.
My question is, comparing SKB264, actually you started the phase III study in 2024. You are making good progress, because you have already enrolled for a year, so you have a lot of data built already. I am curious that in the global multi-center, EGFR mutated first line was not initiated yet. My question is, for this indication, this is a big indication. Tagrisso already has about $6 billion-$8 billion sales because FLAURA2, compared with the Tagrisso, which is osimertinib, they also have much longer mean PFS. Normally combining ADC with Tagrisso, we are supposed to have a higher sales dollar amount. It is going to be a very big win, but we have not seen the global initiation of that indication. I was wondering, do you have a better choice? Also, is there potential opportunity of SKB571?
If that is the case, what is the advantage of SKB571 in that indication? Also, if you were to conduct clinical study, would you compare with FLAURA2 as a head-to-head?
Okay. Thank you. First question, first of all, about the global phase III, EGFR mutated first line, you are asking about the consideration, and SKB571, the prospect SKB571. Maybe Dr. Jin, can you take that one?
That is an excellent question. Indeed, in China, we actually have a social study that has been quite early. The last patient enrolled was in last September, sorry, last July. Up to now, we have been treating patient for over a year now. We are looking forward to it because the data is so good. Phase IV data is kind of slower than what we have thought, so probably we will not be reading the phase IV data out until Q1 next year.
When it comes to MSD's global development, there are things that we are not in the position to make disclosure. On the one hand, the phase III clinical data, can it be used for application in other country or other region? We are trying to explore that. Secondly, for SKB571, indeed. SKB571 is another important collaboration with MSD after the SKB264. We have not been disclosing the target. However, it is actually having a very good advantage among the populations. So we will consider developing the molecule SKB571 combined in the second phase. In the future, globally, are we going to do a head-to-head with FLAURA2 in the phase III? For the control group, because the MARIPOSA has been approved in U.S., so at least, the control group needs to include the MARIPOSA as a regimen. So those could be part of consideration.
Thank you. I have another question regarding the PD-1 VEGF strategy. Now, with MSD, you both have a PD-1 VEGF. In the intro result the last time, it was mentioned by Mr. Ding that PD-1 VEGF, they will be using their PD-L1 VEGF. It is already on the agenda. Kelun-Biotech, you have your own PD-L1 VEGF, and in your presentation, you also mentioned the combination therapy used on non-small cell lung cancer. My question is, in terms of ADC and PD-L1 VEGF combination, are you going to plan separately, one in China, the other differently for overseas? If that is the case, for your ADC combination indication, what will be indication other than small cell lung cancer? What are the indications and what are priorities? Thank you.
When it comes to development in China, overseas, actually, we have the PD-L1 from Crescent, the right in China.
We do have the right to develop the combination in China. In the ASCO and other investor meeting, because they already bought BGB's PD-L1 at the time, they have the right to develop. I think both sides have the right to make their own independent developments. Respectively, we also have strategy setting for our own development. On both sides, we have been maintaining a very nice communication pathways and channels. We will consider at the right timing or the right time to see if there could be any synergy. When it come to the PD-1 VEGF development strategy, again, Dr. Jin, can you talk about PD-1 VEGF development?
Yeah, it was mentioned. If you've been following the announcements or MSD's announcement, the two PD-1 VEGF, they have the tetravalent structure, like PD-1 VEGF as a backbone.
Those are very similar. It is mentioned that MSD is developing PD-1 VEGF. They have done a lot. In the past, the lunbotinib and many other experience already achieved, including lunbotinib. Also the sac-TMT is covering a broad range of tumors. We are thinking like sac-TMT with PD-1 VEGF, first of all, is on the non-small cell lung cancer because the TROP2 ADC combined with pembrolizumab being successful. We are looking forward to TROP2 ADC sac-TMT to have a flexible application of PDF, PD-L1 on the non-small cell lung cancer. We also consider other tumor like breast cancer, but sac-TMT address multiple tumors, a broad range of tumors. They have nice anti-tumor activities. As mentioned, we are actively exploring and sharing our second phase POC data in China with MSD. Hopefully we will support MSD to have a sac-TMT PD-1 combination therapy in the world.
Previously, MSD has launched 17 sac-TMT phase III study, and many phase III are in combination with sac-TMT, combined with their own pembrolizumab PD-L1. In the future, we are looking forward to MSD to use sac-TMT to combine with PD-1 VEGF in multiple tumors in global phase III studies.
Thank you for having me. I like to ask further follow-up. You have the 11A, which you have obtained the China right for 11A. What is your strategy consideration for getting the China right for 11A? Understanding, of course, they have a very nice clinical significance in the phase II, which help us understand the clinical benefit of ADC plus PD-1 or PD-L1. Also plans to advance product to achieve China registration. The second question is what I was just mentioned, that you have talked about putting immunotherapy and ADC together, and putting them into the same molecule.
I would like to ask, in the case of ADC plus PD-1 and PD-L1, which is a more direct combination therapy, what kind of differentiation want to see by making them into a same molecule?
The first question about positioning strategy for 11A. I think Mr. Ge, can you take that?
I think this is a very nice question. Previously we have been talking about PD-1 VEGF. These are three different anti-tumor mechanism vis-à-vis ADC. One is the cell killing, the other is immunity, and also VEGF is about anti-angiogenesis. We are looking for combining the three mechanism in combination, they can play the respective role as in synergy. First of all, we are still exploring. Right now, we are exploring. It is not just about efficacy. More importantly, we want to see the safety and the combination.
Will the safety be supportive of a longer-term benefit from that product. That is the most important thing that we are looking at now. Secondly, for us, the OptiDC, which is an ADC platform, this is our backbone including different drug conjugates, which is the backbone of the company. Regardless of different combination immunotherapy combined with monoclonal antibody or combination of PD-L1 or VEGF or combination with TKI, it is all around the drug conjugate. It is a combination with our own drug conjugate based on the conjugation technology. Back to 11A, it is going to be a nice partner with ADC, with different ADC, different tumor. We are evaluating the anti-tumor activity and based on the tumor microenvironments and different feature of a tumor. We are going to explore those features. Where are we going to go for clinical registration?
For monotherapy, we do not have plan for clinical registration of 11A as a monotherapy. At least now we will think of it as a combination partner ADC. At least this is how it is being envisioned as a combination together with ADC. The second is of ADC-IO integration design. Talk about our integration including payload integration with two mechanism and also the antibody integration. Dr. Yu, Dr. Tan is here. We have the synergy of the payload and the synergy of the antibody. Can you talk about that?
Let me respond to that. The dual payload by SKB565 is one with traditional cytokine with an immuno-stimulatory component. This is a mechanism compared with the ADC plus IO, it is somewhat different with ADC plus IO.
If you make it into one single molecule, the benefit is, or the differentiation is that it has a fixed ratio that can make entry into tumor cells. You can regulate how much of cytokine toxin, how much immuno molecule get into the tumor cell to play the best effect. The second point, ADC. Now, once ADC goes in, there are so many tumor cells. You are not able to ensure that they are getting into the same cell. However, if we can make into one single molecule, then the two payload can get into the tumor cell together at the same time. Potentially, in theory, we are going to have better tumor killing, and also other benefits. If you have one single molecule combining two, then for patients, it might be a benefit economically, particularly overseas.
Of course, they want to solve the problem with one drug rather than two. All our products are not just thinking about China, but also international markets. We have to think about all different considerations.
Let me add to it. You probably have seen like the HARMONi-6, the updated data from HARMONi-6, PD-1, VEGF plus chemo. PFS was actually 0.72, which is updated data, which means PD-1 plus chemo could be better than PD-1 plus chemo. However, it has not achieved a very good ideal therapeutic results. I think in PD-1, PD-L1 plus ADC plus the sac-TMT, and then the immuno agonists could be anchor the TTA onto one molecule. Maybe we are able to turn a cold tumor into hot tumor so that the immunity effect can be better enhanced. At the same time, we are thinking about a SKB103, like SKB103 molecule.
Can we put on top PD-L1 and VEGF so the immune agitation can achieve better potency of immunity agitation? In the first line, in non-small cell lung cancer, many cold tumor, they can actually add on the immunity effect so that the benefit can be more enduring. The ultimate goal is about survival. It's not just about ORR. We want to achieve OS benefit. That's the design. We're thinking, designing different thing into one molecule with PD-1, VEGF, and IO. Maybe we can achieve better OS benefit. That's the ultimate goal. If you look at the ADC journey, you can see at the very beginning, we look at ADC and bispecific, bi-payload ADC, and then you can see ADC combined with PD-1 combination. You see the results of how ADC combined with PD-L1. We have better benefits.
In a journey, we're trying to put the advantage of ADC and advantage of IO into one molecule. We're combining ADC and IO target into one molecule. SKB-D103 as a project, you can see we have not stopped the progress in the exploration. In ADC, we're constantly pursuing a better anti-tumor effect and a longer interval before drug resistance arise. Also we are having better and better immunotherapy, better IOs, like ADC combined with VEGF. We have very nice effects, very nice results in PD-1 VEGF. Also our SKB118, the results of our own SKB118 was also very good. I think the combination of IO, the bispecific IO, it's not just about ADC. Sorry, it's not just about PD-1 and VEGF. Actually, we continue to explore the process.
I think that's a very good question. Right now, we're not able to answer it completely. What's the ultimate clinical value? Should it be in combination therapy or should we make them into one molecule? We say it could be better safety, better efficacy. However, I think this is still an open topic. This question is still open. Everybody can see the simple combination. If you just put two drugs in combination, the benefit is you can adjust the dosage more flexibly. However, for two molecule, I can adjust any single molecule, the dosage, it has advantage. Because in one molecule, we have different development strategy. I didn't elaborate today. If we were to make it into one single molecule, what is the advantage over a combination therapy? This is really set by our TDP. You can promote its endocytosis, it can promote release in the tumor microenvironment.
In the translational research, what is the pharmacodynamics or pharmacological research, we can expect a synergy effect. This is where we are developing into optimize integrated molecule. We do have our TDP. We're not able to elaborate, but you have to think about the effect before integration.
There's a question about sales. We talk a lot about the first half of the year, the sales figure has been very nice. You talk about you have medical reimbursement covering the two second-line indications, and there's going to be also a non-mutant first-line indication to be declared and approved. I'd like to talk about the medical insurance negotiation, some prospective information, anything you can share with us, and the sales outlook for the next year. Let me respond to the second question right now. We're now at a stage of making estimates.
So whether 264 with a new additional indication or the 166, if they were to be enrolled into the Chinese review. If you understand, this year the national negotiation has the lowest pass rate in history. Last year we had 40% success, but this year it is only 34% success to pass the review. So right now, we are talking to the authority, we are talking with the experts. I am not saying we have a price advantage, but we are actually progressing toward our goals. So I expect next month it will be approved because this year the speed has been very fast. So perhaps the negotiation could be done by September already. You talk about commercialization outlook. First of all, we can expect further headcount increase, that is for sure. Because next year we have two more indication to be covered by medical insurance.
For the second line, EGFR mutant population, definitely for that indication, this population will achieve greater results. For the HR-positive, HER2-negative indication, definitely this is a much bigger population compared with the current TNBC. So we are very confident in the market growth next year. In terms of commercialization, next year, we are not just having 264, we are also going to have 166 to be covered by reimbursement. So we continue to build up our breast cancer team. We have break it apart as a separate team. We are going to increase the headcount.
Thank you.
Thank you for having me. A quick question. You have three commercialized product. You have disclosed the revenue for the first half of the year. Can you break it down by product, like 264 and the revenue from non-264? And second question is a follow-up on the commercialization.
Because up till OptiTROP-Lung05, combined with pembrolizumab, this has been submitted for application for launch. We can expect the approval, commercialization, and reimbursement coverage. So my question, how would you work with the pembrolizumab to collaborate with pembrolizumab for the national negotiation assets? What information can you share with us?
First of all, in terms of disclosure I think Mr. Ding can talk about.
You talk about the sales disclosure. We talk about some key products, including the sales positioning of different products. Well, of course, most revenue come from sac-TMT, 80% come from 264.
The second question, Mr. Wei.
Based on the disclosed data in treatment, particularly the wide type lung cancer, our data is very impressive. So in the future, we are going to be practice-changing. If you just look at the data, this is an indication, has huge clinical value.
Secondly, in combination with pembrolizumab, we are working on the medical reimbursement for the indication. First of all, we talk to the regulator, industrial association, and universities. We are trying to shape the policy. We try to change the policy. As you know pembrolizumab is not covered by reimbursement. Secondly, we are also talking with MSD. So next year, maybe it is possible for both of us to be covered by reimbursement. It is still some time before we got approval, but we still have a lot to do. But we have started it from the end of last year.
Linda?
Thank you, for having me. I have two questions. First of all, you have clinical progress for new type ADC other than 264. You also have, like SKB112, SKB32. You are making clinical studies, both home and abroad. So I would like to ask about ADC 2.0, the next generation ADC.
Do you have any advantageous pipeline where you are going to prioritize clinical phase III? I want to ask about the sequence for your later pipelines. Any key indications? I want to learn about the key indications, if possible. Also, you reached a settlement with Yilian and you received RMB 700 million in June in settlement. I would like to ask about the confirmed amount in the second half and any profit sharing from the product.
To your first question, you talk about the second-phase molecules and how we think about the planning for phase III. Maybe Dr. Jin, you can talk about it, how we think about the phase III study for the current molecule in phase II.
That is a good question. SKB264 has been a successful development, and SKB264, as I mentioned, we are moving from later line to first-line and also making its way to breast cancer, lung cancer, and many other tumors. We have exploration in phase III, and data have been very impressive, which give us challenges in developing subsequent ADC pipelines. As I mentioned, the SKB410 is being developed by MSD globally, as many phase II studies. Now in SKB315 with claudin ADC and a bispecific ADC, which is a SKB570 and SKB500, were reported data on ASCO. Also B7-H3 ADC, the data on small cell lung cancer, esophageal cancer, the data are also very impressive. We have many ideas. Very often we want to go after big indications. We do not want to have rapid launch on the small indication. We are more interested to get into large indications.
In choosing indication for phase III study and developing phase III study, we are more cautious. We might prioritize developing big indications or earlier line or first-line, so we include some combination combining with IO or IO 2.0. We will disclose more development plans in phase III study. Second question for Medilink settlement. We already made announcements. We have six molecules where historically or in the future, every payment will be shared with us by a certain proportion.
Next question, Mr. [Huang Bo].
A quick question. You got the ADC on the contract grade, you have a lot of development plans. What about the degrader cytotoxic combination or the IO plus cytotoxin? What kind of specific development stage are we at now? When are we going to see this kind of POC experiment?
For different payload combination, there are a few things. IO plus cytotoxin, we already have one project in clinical studies on patients. Degrader, plus the toxin is another important strategy because degrader, you have seen we have some patent disclosure, which is a very important direction. Dr. Yu, maybe you can add to it.
There are two levels. For degrader development, we have some consideration. The degrader itself from Kelun-Biotech, we have done some work on it over the years. Also our degrader is called DAC which is a mechanism of dual targeting. On top of the degrader ADC, we are combining with cytotoxin, which is actually taking it further. DAC also put on top of cytotoxin. That is making ADC more interesting. ADC is just a delivery system, right? We have a lot of potential to come up with different structure to combine with different mechanism for synergies. Dr. Yu?
Yeah, let me add to it. Our ADC platform and our understanding of payload is no longer using payload that we used to. We talk about degrader, we have an immuno-stimulator, and even have small molecule. We are trying to put them as a payload. We are not simply developing something and just add on different stuff in theory. There is a lot to be verified. Our goal is that by putting two payload together, by putting two molecule together, there has to be differentiation. There has to be a better ADC, better efficacy, or even better safety. Safety is the bottom line. It has to be safe, but we want to have more efficacy to overcome the tumor heterogeneity with better PFS and OS. Before launching the clinical study, we have to fully verify.
This is the biggest challenge, sorry, this is the biggest priority that we are doing now. When can we go proceed to POC? Dr. Zhou mentioned we are now about to enter clinical phase I, and subsequently there will be project coming out. Andy, you also have your hand up.
I think for MSD, in their overseas clinical study, maybe you are not in a position to comment on MSD, but the market is interested in the first line, non-small cell lung cancer, particularly PD-L1 below 50%. We have two large clinical phase III study in China with positive results. MSD talk about some idea that they likely want to expand into that direction. In terms of partnership with MSD, as you said, MSD, they decide their phase III study. It is up to them. It will be up to MSD.
I believe in recent MSD earning calls, a lot of investors were asking them. I think MSD has provided very good answer already. Like the OptiTROP-Lung05, OptiTROP-Lung06, I think there have been published data, right? OptiTROP-Lung06, there will be data published in the second half the year. For this data, it is a very good reference and inspiration for MSD. Also for themselves, like lung cancer. Lung cancer is really the key to MSD, like KEYTRUDA. A lot of revenue of KEYTRUDA come from lung cancer indication. I am sure MSD take it very seriously. When they are responding to investor, they already talk about their plans.
Actually in the partnership with MSD, the reason why we have a joint steering committee, that is really because for the study, for us to engage and for the data that we acquire from this study will be shared, but we are not in a position to review our strategy. I think they previously used a name like Cornerstone, sac-TMT is called a Cornerstone for other product development. Sac-TMT is going to be adopted in large indications, even for the first line. They do have the plans with or without KEYTRUDA or in combining with bispecific or other molecule, they will consider heavily on sac-TMT.
I just want to add on, like Mr. Ge said it very well. So even though our data would not be presented at ESMO until October, but actually when we got positive results, the OptiTROP-Lung06, particularly the sac-TMT plus pembrolizumab, the results compared with pembro plus chemo, the data has been shared with MSD. A positive result has been shared with MSD, like OptiTROP-Lung05/06. The results of phase III study, particularly efficacy and safety, particularly pneumonia, has given MSD a great confidence. Like HARMONi-6 presented on ASCO, I think this has also helped MSD to think about their development on lung cancer.
Thank you. A couple of days ago, like Dato-DXd, they're also going to read our data phase III clinical study second half this year or next year for Dato-DXd. So, what do you think of the likely results of that?
It's only a hypothesis. How can I answer that?
Yeah, but what is your clinical strategy? Are you going to make some biomarker, like TROP2 biomarker screening, when you expanding the first line on small lung cancer in the future? Are you going to combine with chemo? Are you going to replace chemo with TROP2 ADC?
I understand your question. From the analyst point of view, you do take care of this, the sac-TMT, and the all TROP2 ADC. They have similar indications. Assuming they have a success or unsuccessful results, it's not black and white. We have to see the actual data, right? They might have a lot of certification analysis, and a subgroup analysis. So we want to see what happen in the subgroup analysis and subgroup performance. You have to see the actual data publication before we make decisions or judgments. So if you just say, "Oh, if sac-TMT to be successful or not successful," it's going to be too arbitrary.
We will keep monitor. If data is published, of course, we'll happy to respond after data is published. But I remember that question has been asked two years ago. People ask me, "What do you think if it's successful or not?" I remember at the time was saying, "If it's not successful, people will wonder maybe TROP2 doesn't work." People will challenge us. If it's successful, maybe it's impact your market. So two years ago, I got the exact same question. So I'm thinking, first of all, TROP2 has been proven successful in our case, in our phase III study, where we are proven to be best in class. We are very confident in this because we are the first to have a positive results in lung cancer, and also we are also the first in the IO plus IO ADC. Also, we're the first to have positive result in the immuno plus ADC. So whatever data they present, we're going to be the best.
Maybe we leave the last two question for the online. We also have lot of people raising hands, so let me take it by turns. Matthew from CLSA.
Thank you. Thank you, for having me. I'm Matthew from CLSA. Two questions. First, about your commercialization full-year forecast. At the beginning of year, you mentioned you expect a doubling over last year. In the first half, you have very nice results. So my question is, what's your commercialization revenue for the full year? Would you make changes? Second question is sac-TMT indication. We often talk about indications other than the large indication that we often talk about. What about bladder cancer? Do you have any consideration of bladder cancer?
Because like Dato-DXd, they have a phase III study on mUC to challenge the study of EV plus pembro. Would you consider the same for sac-TMT?
For your first question, I think it has been responded before. Indeed, in March, in the NDR, we have been guided for the commercialized revenue for this year. At least we are going to double, which is the target. You can see in the first half the year, we have excellent achievement for the target in the first half. For the commercialization sales of the second half, in terms of more coverage, important, and more education for the doctor and better education for the patient, we are more confident in the sales in the second half. Of course we talk about at least doubling, but hopefully we can have better commercialization results. Also the sac-TMT in the bladder cancer, Dr. Jin?
If you are looking at the bladder, actually sac-TMT in the ASCO GU, we have made multiple reports on the bladder cancer, UC data. If you look at MSD, they started 17 phase III, which includes bladder cancer in second line, particularly for patient who fail EV, plus the PD-1 treatment, in the second line. Also included in the early clinicaltrials.gov, where they register and they explore sac-TMT plus pembrolizumab plus LAG-3, in a EV combination. Because MSD has a lot experience in bladder cancer, particularly the EV plus pembro, where they have very successful development. Whether it is the first line or early MIBC, they have been very successful. I think they will have a lot of consideration. They have a lot to do in bladder cancer.
MSD has done a lot in bladder cancer, many global phase IIIs, so we did not start our own phase III study in China because bladder cancer is a smaller indication. We like to rely on MSD for global study for bladder cancer. MSD's global phase III might include center from China. Probably we will use the global data for China application. Usually, we will not repeat the same study for the same indication in China. Of course, lung cancer, we do separate study in China, and also subsequently in the 11A, in terms of combination with 11A, we will consider in the first line, like in China, mostly in lung cancer, breast cancer, and then going beyond that, we might also think about the GI cancer, gynecology cancer, urology cancer. We will also consider exploration in the future.
Last question. [Liu Yasin] from CICC.
Thank you for having me. I am [Liu Yasin] from CICC. I have a question for expenses and profit. You can say R&D expenses. Used to be focused on SKB264, and now you have multiple developments, phase II combination, and also many other study. What do you think of the R&D expenses in the second half of the year? Where would you invest more resources in R&D? Also regarding profit, you have very nice adjusted net profit, close to 400 million. You used to expect a company to turn a profit in 2027. Now, based on the current profit, would you update the guidance?
Very good question. Regarding R&D expenses in the first half, as mentioned, we grew slightly year-on-year in expenses, R&D. Like R&D, clinical. This is in line with our clinical progress. Structurally speaking, we maintain a very stable R&D structure.
The overall expenses is the cost of R&D personnel and the expenses from clinical trial, particularly pivotal clinical trials and R&D expenses. Those are the major component R&D expenses. R&D personnel, we now have 1,000 people in total. They are going to be stable in a short period of time and also the clinical trials. Even if you have more late-stage clinical trials, the cost is on a rolling basis because they are still going to be accruing gradually accruing and booked. We expect R&D expenses to maintain a rather stable state. If you look at what happened in the last three years, you are seeing a slight growth every year. That is R&D expense. Regarding breaking even, as we understand, the market is very interested. Mr. Ge has talked about it, like Kelun-Biotech. We are now seeing the momentum of commercialization as opportunity.
In the early stage, we are called a biopharma. We are now converting to a biopharma. We are now in the transitional phase. There is going to be a major change in the business structure. In term of revenue, in the past, we are mainly having revenue from collaboration in R&D. We have more revenue from commercialization, so the revenue is more diverse, and we are going to have more cash inflow for commercialization. This will gradually build up our profit. It was mentioned, like the collaboration, if the collaboration become deeper, and also the sac-TMT is going to be launched in U.S. next year. This also going to trigger the commercialization milestone, including development milestone, commercial milestone, and commercial royalties, which will bring us very nice profit and income for the company in the future. As for the breaking even, the company is now driven by two wheels.
We have a two-wheel-drive profit model, so breaking even won't take long. Whether it is going to be this year or next year, I think that depends on the actual business performance. I think from the market, from the investor analyst, I think you want to see the company a long-term break even. When the company broke even, this is going to be a commitment to the market. We are going to tell the market that from now on, you can expect long-term profitability. That is the break even that we want to achieve. That is the real break even. For R&D, I would like to add, in the first half, R&D increased by 25% year on year. R&D expenses, I think that is a good question. You can see the change R&D investment.
In the past, R&D was focused on 264 ADC, which is mostly the R&D expenses for R&D for ADC-264, but the future is going to include two parts. First of all, ADC plus IO, further combination with ADC plus IO. Secondly, we are going to have many phase II study. Another important development is the new type of ADC, new type of technology, new conjugation technology in clinical study. In the second half, I agree with Mr. Zhou, you might have a slight growth in the second half or maybe stable in the second half. But in the future, you can expect growth on R&D expenses. Those R&D investment will provide greater momentum for the future growth and development for the company.
Okay, that is the time we have for the day, and that will conclude our interim results presentation. Any more question, happy to take them offline. In the coming days, the company management will have a roadshow in Hong Kong and other cities. Mr. Ge, can I ask you for our final review?
Thank you for the time. We have overrun quite a bit. During presentation, the management overrun by a few minutes. Importantly, you asked many good questions. Those are very nice questions. The questions are great because they give us opportunity to present our strategy and present the products, and present the prospect of the pipelines. I think those communication, I think it is also beneficial for us because in interim results, annual result presentation, I think investors has been able to provide feedbacks which in turn to be great guidance to us. So that in terms of the future R&D project pipeline and clinical indication development, your question provide good guidance. Thank you very much. Thank you for the time.
Thank you.