It's going to last for an hour. We are going to first present the interim results of the company before opening the floor for Q&A. This meeting will be recorded for internal use and also for our client's use. Any forward-looking statements made during the call are based on current expectations and assumptions made by the management. The actual outcomes may differ materially from those statements. The company entertains no obligation to update or revise any forward-looking statement unless required by the applicable laws or regulations.
Within the next one hour, we are going to present our 2025 first-quarter performance in terms of both business and finance, followed by a Q&A session. Management presentation will be conducted in Mandarin with English interpretation. Please switch to English channel if you prefer the English language. This conference call will be recorded and provided to Kelun Biotech's clients or used internally for reference and distribution. Any forward-looking statements made during this call are based on current expectations and assumptions made by the management. The company entertains no obligation to update or revise unless required by laws or regulations. The allocated information is just for reference only and should not be considered as investment advice or guaranteeing of the future performance. [Foreign langauge].
Now, allow me to introduce the management representatives on the company side. We have the CEO and General Manager of the company.
[Foreign langauge] Chief Strategy Officer, Mr. Feng, [Foreign langauge] Chief Scientific Officer (Biologics), Dr. Chen, [Foreign langauge] Chief Scientific Officer (Small Molecule), Dr. Yu, [Foreign langauge], Chief Medical Officer, Dr. Jin, [Foreign langauge] Chief Marketing Officer, Mr. Ding, [Foreign langauge] Chief Officer for Distribution Management and Market Access, Mr. Chen, [Foreign langauge] VP of Small Molecule R&D, Dr. Zhou, [Foreign langauge] Chief Financial Officer, Mr. Zhou,[Foreign langauge] CEO。
Coming up, I'm going to give the floor to the CEO of the company, Mr. Liu. Please go ahead.
Hi, everyone. Good evening. Thank you so much for taking the time to join our 2025 interim results presentation of Kelun Biotech. We are going to cover four parts during the presentation. First of all, on behalf of the company, I am going to review the performance of the company for the first half of 2025. The second part is our commercialization, which I think many of you are interested in. We will have Mr. Ding and also Mrs. Chen introducing these two parts regarding the marketing and commercialization and also the go-to-market part of the company. The third part is the clinical information, which will be led by Dr. Jin. The last part will be the financials, which will be presented by our CFO, Mr. Zhou. After the company's prepared remarks and presentation, we will open the floor for a Q&A.
We are going to allocate the questions to the dedicated people. First of all, the first part of the presentation, which will take about 10 minutes, is about the company overview. I think you're all very familiar with this page. I think we've been at this company for over two years. We have been presenting this page across multiple occasions, and so y ou can see the biggest shareholder was our Kelun Pharmaceutical, which was our parent company. The second biggest shareholder is MSCI. MSCI, which also is a well-known company in the world. Apart from these two major shareholders, we also have a world-leading R&D platform for ADC and other leading drugs as well. Right now, we actually have about over 30 projects on the pipeline. Across clinical trial stage, we have over 10 projects.
By the first half of this year, we have actually gotten a lot of progress when it comes to approval. We already have three products that have already finished the approval for five indications. We also have four in the process of VN NDA approval. We also have two other products, which we will introduce later. When it comes to operation, we actually have over 1,870 people across the company, and y ou can see when it comes to the headcount, mainly it comes from the R&D. Apart from that, it mainly comes from the commercialization and business development team as well. It's mainly preparing for our go-to-market and also market access personnel. We actually have about nearly 400 people in the commercialization team because we now have more and more products ready for the market.
We definitely need to increase personnel and headcount in marketing and also commercialization and production and quality control as well. When it comes to our product pipeline, we can see that we actually have three main products that are ready for the market. The first one is SKB264, also known as MK2-2872. The indication is, first of all, TNBC. We also have the wild, sorry, Milton-type lung cancer. First of all, for TNBC, we are actually the first in China that actually have gotten the approval as a Trop-2 ADC for TNBC. We also would like to mention that we also got an approval, you know, as the first in the industry, globally speaking, for lung cancer as our target indication this year. For our Sutisma 201 project, we also got an approval also by the end of last year for our PD-1 A167 project.
Also gotten approval for a first-line indication as well. Right now, for NDA approval process, we first have our 264, which is a second-line lung cancer indication. In the first half of the year, we have submitted a new NDA for approval, which is for HR2 positive and HR2 negative indication. We also have A166 drugs as an ADC for two indications that are waiting for approval. Clinically speaking, we have several types of products. The first one is that we have adopted a differentiated conjugation strategy, including our 315, 410, 500, and 501 projects. We also have some potential target ADC projects. For example, SKB518, SKB571. This is our first bi-specific ADC. We also have SKB535 and SKB445. These projects are also in clinical trial stages as well. Dr. Jin is going to give you more information later.
This year, we also have another project that is in clinical trial stage, which is our first RDC, SKB107. This also has entered the clinical trial stage. Next page, I would like to talk about our global partnership. When it comes to international or global partnership and also internationalization of our products, these have always remained very important and critical for our development. Apart from our important collaboration with MSD W e also have, for example, other products that are in partnership with MSD . Obviously, for the past two years, MSD has kicked off 14 TMT-related clinical trial projects, including monotherapy or Combotherapy . They have launched these global phase three registrational clinical trials experiments around the world.
At the same time, at the beginning of the year, actually, beginning from the end of last year and the beginning of this year, we also have launched a new partnership regarding SKB378. Recently, this project has entered the global phase two clinical trial. Next page is our OptiDC™ ADC R&D strategy. This is very, very important. For the past year, it has actually generated a lot of interest, and I think we've talked about this before, I'm not going to go into the detail. I would like to actually talk about the areas that we want to cover, which is oncology and non-oncology. For oncology, we actually have the replacement of chemotherapy and also going beyond chemotherapy. For replacement, we have novel targets. We also have payload MOA. We also have new conjugation as strategies to replace chemotherapy. These are our main strategies for replacing chemotherapy using our OptiDC™ platform.
When it comes to going beyond chemotherapy, we have, for example, other payload MOAs and also adaptive compound structures as new strategies. As we mentioned previously, we have already gotten some pipeline products going into clinical trials. The next page is our year-to-date achievements. First of all, we would like to report that we already have products ready for the market that are on market. Apart from the sac-TMT for third-line EMFG and non-small cell lung cancer, we also have second-line plus HR positive and HER2 negative breast cancer. We have already submitted the NDA and actually, NDA have accepted the approval. We also have multiple pivotal trials initiated, not only in China but also globally, because globally, M SD has kicked off four trials in the first half of 2025 for OCEC, TNBC, and HR low positive and HER2 negative breast cancer.
These are global trials kicked off or launched by M SD. We also have been granted breakthrough therapy for breakthrough drugs for first-line non-small cell lung cancer. We also have released a lot of data across different conferences, including ASCO and also our second line, sorry, our phase two first-line TNBC results, etcetera. At the same time, regarding the two trials on lung cancer, we have published data for the first half of the year in BMJ. We have also launched our third-line registrational trial results. We also have published our phase one two non-small cell lung cancer EGFR, Milton-type non-small cell lung cancer data. Also, first half of the year, we would like to also report our A166. A166 has gotten approval to become the, to actually carry out the cross-provincial segmented production pilot program because of its unique conjugation and also payload and also its antibody and DSCP.
Thanks to the new guideline from the government, we need to actually carry out the segmented production. The country has actually kicked off some pilot programs. This year, we submitted the approval. Next year, it will be a one-year-long pilot program. Based on that result, we will be pending whether or not it will actually be launched large scale. Our project A166 has successfully gotten the approval to carry out the cross-provincial segmented production pilot program. Once you've gotten the pilot approval, you can actually proceed and push forward the next level or next step of the testing and production and approval. Now, for other projects, for example, A167 and also A140, you know, those are already on market. We also have published data as well. For example, we also have the RET inhibitor. I think Dr. Jin is going to give you more clinical trial data elaboration later.
Another thing that we would like to report is our financing from the capital market. We completed the H-share follow-on, $250 million worth of H-share listing. Sorry, not listing, but financing. At the same time, we are currently included as a constituent of the MSCI Global Standard Indexes and also FTSE Global Equity Index Series and Hang Seng Index as well. The next page is also very consistent with what we previously mentioned and we always uphold, which is on the company level, our strategy has always been advancing differentiated pipelines targeting indications with significant medical needs. We also optimize payload. We will continue to optimize our payload linker strategies with novel ADC designs and structures. We are going to explore application into non-oncology as well. Since last year, we have also strengthened and enhanced our end-to-end drug development and commercialization capabilities.
We have already achieved this closed loop of R&D plus commercialization and production as well. We will continue to expand our global footprints and strengthen our strategic partnership to maximize the value of our pipelines. At the same time, we will optimize our operational system to become a leading global biopharmaceutical company so that we can become more and more comprehensive as a company and also more efficient from the management's perspective as a global biopharmaceutical company. Thank you, Mr. Gu, for your comprehensive introduction and review of the company. Coming up, Mr. Ding and also Mr. Chen are going to talk about our sales and marketing and also our market access so that we can understand better what we've achieved for the first half of 2025. Mr. Ding, please go ahead.
Great. Can you hear me okay? Do I come through okay?
Yes. Very clear.
Hi, everyone. Good evening. For the first half of 2025, we definitely believe that this is the first chapter and first year of our commercialization. We also have really launched our first ADC as commercialized drugs. The total sales revenue has achieved our expectations, which is around ¥300 million. For the first half, so far, we have already covered actually over 30 provinces. From the city level, we have covered 300 cities. We also have covered over 1,000 hospitals across China with over 10,000 doctors covered as well. We also have successfully gotten into Cisco non-small cell lung cancer and also key guidelines, etc. At the same time, for the first half, we have already started partnership with over 400 pharmacies across China. If we look at the comparison from second half to first half, we believe that the first half has gotten a lot of new approvals for new indications.
We have launched different specifications of the drugs. Those have built a very solid foundation for the second half of the year. That's my very brief overview of the commercialization of our drugs for the first half. If you have any questions, I can elaborate later. Hi, everyone. I would like to also talk about our market access of the company's drugs for the first half of the year. We have three products ready for the market or they are already on the market. We have already launched a lot of partnerships with the important partners. For example, we have covered professional pharmacies, 400 of them. Some of them are dual-channel pharmacies. Some of them are actually specific pharmacies as well. Now, for our new drugs, as we mentioned, we have been going into different channels.
We're trying to cover actually 4,500 pharmacies in the first half of the year, which significantly enhanced the professionalism of our terminal services and also improved the ability to provide patients with our drugs. At the same time, right now, our drugs are in the out-of-pocket area. It's not being covered by medical insurance yet. We need to do some more development. For the first half of the year, we have accumulatively covered actually 29 provinces. For our product, A167, we have covered 25 provinces. A lot of the interest has been surrounding the application or the approval of going into the medical insurance coverage. Actually, today is the last day of this process, and I think this is the last stage of the final review. I think one thing that I would like to mention is that domestically, there are all kinds of insurance, including the medical insurance.
We have already successfully covered seven provinces going into this specific kind of affordable care. We also have gotten into 20 cities into another type of medical care, trying to solve some of the medical expense issues for using our drugs. That's all for the market access and commercialization. Coming up, Dr. Jin is going to walk you through our clinical trial development.
Hi, everyone. Coming up, I'm going to update you on our clinical development for 1H 2025. As was mentioned by our CEO, Dr. Ge, we talked about some of the key clinical studies. We already have three drugs that are on market. We also have some misses NDA approval for second-line HR positive and HER2 negative breast cancer. Hopefully, with ISMO, we actually can have more recognition of our phase three results.
For our second-line TKI resistance, non-small cell lung cancer indication, we also are looking forward to publishing the results. Hopefully, we can get approval by the end of the year. Hopefully, we can also present the large phase three trial results on ASCO this year. Another thing that we would like to mention is that in registrational phase three projects, mainly we would like to talk about the SKB264 for CDK46 inhibitor failure, first-line failure breast cancer. This kind of subtype phase three trial is something that we would like to mention, so t his is a registrational research. Another thing is that our focus is shifting from SKB264 to some other ADC pipeline projects. For the first half of 2025, we actually have a lot of ADC projects that have gotten R&D approval, that got into clinical trials. As was mentioned by Dr. Ge, we have a lot of first-in-class ADC.
We also have bi-specific ADCs. A lot of ADCs, as the first half ramps up, we have entered the escalation trial and going into, you know, actually phase two. Hopefully, by next year, we can actually expand the indication into covering more. We also can explore maybe a flexible administration. Also with our clinical trial study, we can actually expand our ADC pipeline into registrational phase three trials. Besides that, we also can see that the possibility of actually having more trials going into actually clinical trial, especially phase three. Now, one of the key focuses is SKB264 and sac-TMT. As we mentioned, all of the registrational studies are going really well. For example, first-line TNBC, PD-1 in first line. We actually have enrolled over 500 patients, so t his is a large-scale phase three. Hopefully, by the end of the year or beginning of next year, we can get NDA submission.
Another thing that we would like to mention is also for SKB264 sac-TMT. We are moving from late line to actually early lines or first line, especially for second line and also some multi-center phase three trials and also earlier line trials as well. Hopefully, next year, we can submit the NDA approval. We also mentioned that HR positive HER2 negative breast cancer phase three, we have already initiated, w e just finished the patient enrollment. Across the country, we now are launching this project very well and trying to enroll patients into different centers across the country. Obviously, breast cancer and lung cancer are two of the biggest indications. MSD is going to do some differentiation development, for example, for some UC, etcetera. We are doing some early development assistance and empowerment with MSD together. This year, we also presented some data, especially for chemo failure patients.
As you can see, we are very gladly reporting that you can see the results are very, very well. You can actually see that not only for our second-line TNBC phase three results that we would like to report, we also would like to say that by actually 2025, end of the year, we actually can look forward to reading out the OS results for this large-scale phase three registrational study for actually over 400 patients. At the same time, PFS, you can see that first-line TNBC results. PFS has been improved to over 13 months, which is very exciting. Also, combo therapy with our A166 results are really, really exciting. You know, PFS is actually 15 months plus, so w e look forward to phase three trials so that we can re-confirm these very exciting results, very good results. Next page.
Now, for our product project, A166, again, we look forward to getting the approval for HER2 positive breast cancer second-line approval, especially when we look at DS8201 and also a lot of other ADCs, t hey have already gotten into phase three registrational trial. For A166, our positioning is very, very clear, it 's definitely a very unique and differentiated ADC. The toxin that it uses is MAE, which is really rare. Our positioning is to target patients who have developed resistance to TOPO enzyme. Also, because the toxin is very different, that we use here is very different from other ADCs of the same category, we believe that the safety profiles can actually be much better, especially for patients who developed resistance to existing ADCs. Next page. As was mentioned by Dr. Ge, we already have three drugs that are on the market. A167, for example, this already has been commercialized.
From our clinical data, the results have been very, very exciting. It definitely sets us apart from other drugs such as PD-1, PD-L1. Our positioning is basically to use it to combine with other pipeline projects that we developed. For example, with 315 and other pipelines, you can see that they have exciting results targeting, for example, non-small cell lung cancer. It's for combo therapy and also flexible administration as well. 8140 also has been commercialized for first-line RAS wild-type CRC. For clinical trial data, EGFR is a very good target. Definitely, there's a lot of publication regarding it. Together with ADC, there's a lot of synergy that we can look forward to. We definitely are looking forward to explore the combo therapy results with our existing ADC. Now, 8400 is a small molecule drug, and it's a very targeted treatment as well.
For this drug in particular, we actually are preparing for a submission of NDA. Hopefully, by next year, we can get approval for the market. Again, you know, going back to the earlier statement, for 2025, for the second half of 2025 or going into 2026, I think one of our key focuses is to really develop or continue to push forward the early developed pipeline, including small molecule bi-specific projects, which we are in partnership with (MSD) with. ASCO 264, I think these are very, very heavy-weighted or highly looked forward, highly expected drugs that we can actually help launch the phase two lung cancer treatment. We can explore monotherapy and also combo therapy so that we can continue to push forward the development with high efficiency, drawing from our previous experience and learnings from other drugs development. Thank you.
Thank you, Dr. Jin, for your introduction. The last part is our financials of the first half of 2025 of the company. First of all, let's look at the bottom line and also top line, w e have actually recorded ¥950 million as our revenue, w e are very happy to report that this is our first year of commercialization. We actually have achieved the dual driver of not only R&D but also our sales revenue. Among that ¥950 million, actually over ¥300 million come from our commercialized drugs. As was mentioned by our commercial management, we actually have high hopes for the future income from sales revenue. We believe that they will continue to generate cash flow for the company, and w e also are very happy to report that we have income and revenue coming from our R&D partnership on a yearly basis and maintain a very regular contributor to our cash flow.
When you look at the actual execution of the contracts, we have milestones that trigger this revenue based on different conditions. We have a very broad partnership across different pipeline projects. We actually have a very, very natural mismatch of deadlines of recognizing the revenue. On our financial statement, everyone can actually see that our partnership every year generates income, even though they may originate from the previous periods. The continuous income of R&D revenue is very good for the company. For our gross profit, which was ¥660 million, basically, it's comparable to the level of the previous year. Our net loss for the first half of the year is ¥145 million. After the adjustment of the one-off budget and incentives, our adjusted loss was ¥69 million. Now, the page here is our costs and expenses. First of all, our operating costs actually correspond to our income.
As we mentioned, that includes actually our upfront production and also R&D, including optimizing our development craftsmanship. The cost right now, when you look at the operational cost, the main driver or the main item of the cost is those kinds of costs come from the R&D. The R&D cost-related costs can be reimbursed, and so t hat is why the operating cost is over ¥200 million. On the cost in here, R&D that we have to carry out ourselves is actually ¥610 million, so t hat's including our headcount, personnel, etc., and clinical trials, etc. Our clinical expenses for the first half were actually ¥74 million, which is very similar to last year. The next item is our sales and marketing expenses because this year is the first year for our commercialization. For the first half of the year, our sales expenses definitely increased for commercialization purposes. It was ¥119 million.
You can easily do the math. As we mentioned previously, we have very high hopes for our commercialization. We not only want to have revenue, we also want to be profit-making as well. We believe that we can deliver that in the long term. Now, the last page is basically our consolidated balance sheet. As we mentioned, in June, we have finished and run a round of financing, which allows us to actually generate and enrich our cash at hand. By the first half of this year, our cash and financial assets are mainly some bank financing. Our total scale of cash is actually ¥4.5 billion, which is very sufficient in order to support our upcoming R&D and innovation. On the debt side, it's less than ¥1 billion. It's mainly some fluid debts, including some contractual debts or liabilities. Overall, our financial status is really healthy.
That's a very brief introduction and overview of the company's performance for the first half of the year. We now are opening the floor to Q&A. Apart from our online participants, we also have invited a large number of analysts who participate in the meeting offline. If you have any questions online, please raise your hand. We will unmute you when it's your turn to ask the questions. We will also give the opportunity to ask questions offline first too. Who would like to start first? Maybe lady first, Chen Chen?
Thank you. My first question is related to our sales. When we look at the first half, you have RMB 300 million in sales revenue. My question is that for breast cancer and lung cancer, what is the breakdown there? Also, your previous sales revenue guideline, do you still uphold that?
Because it used to be RMB 800 million to RMB 1 billion. Sales expenses are about 60%, right? Going into, for example, medical insurance coverage next year, what do you think your sales expenses ratio will become? Right now, your sales team headcount is about 350 people. Are you going to divide them into different indications as breast cancer, lung cancer, etcetera.? For hospitals, how are you connected with different hospitals? My second question is related to R&D. For example, you have a lot in the pipeline, y ou have bi-specific, y ou have ADC. You also have some projects that you did not disclose the target of. What is your key focus here for your R&D going into the next stage? Thank you so much for your question. The first question is about commercialization, right? Mr. Ding, would you like to take that? Or maybe Mr. Wei?
The second question, I'm going to invite Dr. Yu, Dr. Song to take the second question, right? Let's go.
Let's take the first question first. I think there are several sub-questions included in your first question. I'll take them one by one. The first one, lung cancer is definitely the biggest contributor of the sales revenue. It's consistent with our total patient number and also our indication. Our lung cancer definitely is the bigger contributor of our sales revenue. The second part of your question is our sales and revenue, sorry, our sales expenses. If we got into the national centralized medical insurance, the sales revenue will be lower. Right now, definitely, it's at the highest level for sales expenses because this is the first year of our commercialization. We launched a lot of training programs and promotional programs to educate the market.
As we continue to expand our coverage, I think we are not going to spend as much because when you look at the total number of hospitals, the majority of them actually use these medical insurance-covered products. Once we got into the catalog, I think the operational cost will come down. When it comes to the headcount of the sales team and also the breakdown of people by indication, first of all, for important hospitals, we can do a clear divide. Overall, the team is very comprehensive. We now are connecting with, for example, 100 hospitals. We actually have people who target, for example, breast cancer and lung cancer. In the future, as we continue to advance with medical insurance coverage, I think we are going to connect with more and more hospitals that are not only in top-tier cities but also in lower-tier cities and smaller counties as well.
As we go into lower-tier cities and counties, obviously, those salespeople will have overlapped responsibilities. For top-tier hospitals, obviously, we will divide people based on the indication and oncology. For smaller cities, maybe not so much. When it comes to sales expectation, I think for the second half, definitely lung cancer indication is going to generate more income for us. This year is the first year of our sales and commercialization. We are still laying the groundwork for ADC. We definitely are not trying to just divide the market or get some market share. We also take the responsibility of educating a lot of clinical experts so that they can adopt ADC drugs. I think it will take time to generate results. When we look at the second half of the year, statistically speaking, we expect to actually have more sales revenue by comparison to the first half.
I think I have another part of the question that regards the sales guideline. I mean, any guidance, sorry, any guidance changes on the sales performance?
Yes, I would like to repeat my question. You mentioned that your sales expectation is ¥1 billion. Do you maintain the same guidance?
This is a target that we will work toward.
Got it. Understood. Thank you. All right.
The second question, Dr. Yu, would you like to maybe take that? It's about our focus of R&D and our strategy.
Our early development pipeline is in ADC and small molecule. For ADC, our focus, again, is to target clinical demands and needs and try to develop differentiated products. That's always our goal and big strategy. Specifically speaking, we have several focus. The first one is, you know, just several key points.
The first one is that, as was mentioned, you know, when it comes to targets, we are going after bi-specific targets. Obviously, we are trying to find good combinations of dual targets together. When it comes to the payload, payload-wise, our focus right now is that we are deepening our understanding of payload. Our efforts and our experience are deeper and more strengthened too. We have put a lot of effort into new payload means to actually prepare more payloads that are replacing traditional chemotherapy or to go beyond, actually go beyond chemotherapy. For example, we have payload or dual payload. We also have small molecule as the payload. We have different strategies and different combinations, IABC, and also we have the BAC or protein degradation agents, etcetera. We definitely attach a lot of importance to developing and laying the groundwork for different types of payload.
We have expanded our ADC now to cover non-oncology areas too. I hope I answered your question.
Thank you. The next question.
I would like to follow up on the commercialization. After the 264 commercializing, right now, we have ends of Q3, right? Can you give us some guidelines on the sales trend? The second question is more specific. Actually, two specific questions. The first one is the bi-specific ADC project of 571 that you are in partnership with MSD with. I know that you are kicking off another trial. Can you talk about the treatment and also safety profile right now, the efficacy? Also, let's talk about the dual payload ADC. I remember last year, you mentioned that this is one of your development focus. Six months have passed. Can you share with us your latest development? Thank you, Qinghui, for your question.
For the first part of the question, Mr. Ding, can you take that? The second question for our bi-specific ADC, Dr. Jin is going to take that. For dual payload ADC, maybe Dr. Jin again or maybe Dr. Yu. Q1 to Q3, we were able to record a quarter-over-quarter growth of several dozen percentage points. That's quarter-over-quarter growth. That's all for my answer. Dr. Jin, can you talk about project 571? 571, as we mentioned, this is another really, really heavyweight project that we are going to have a lot of high hopes for after 264. This is one of our blockbuster products. We learned a lot of lessons from SKB264, for example, regarding its safety profile, etc., and the kind of adverse effects that it's going to generate, right? We learned from those, and we have made some improvements on Project 571.
From some of our early days, you know, we also realized that safety profile needs some ramp-up. The target is actually very different because after ADC, the administration dosage may not be as high as bi-specific alone. When it comes to our design, during earlier ramp-up, we actually looked at the targets. For example, CMAP target and looked at the toxicity by comparison with CMAP bi-specific is very different. EGFR, so far, when we look at the reaction from the patient, I mean, from the administration of the drug, I think the safety profile has been actually better than before, than traditional drugs. It's basically consistent with our expectation according to our design scheme and strategy. It's definitely very useful for a combination with PD1 and TKI resistance. Right now, we are still going into phase two expansion study.
I think everything when it comes to the performance is consistent with our expectation. Again, you know, EGFR, Milton, I mean, is a very, very effective indication. We also have seen some initial outcomes from patients as well. Hopefully, for phase two, we can see that it goes into more oncology indications. Hopefully, in the future, we can give you the development reports on the safety profile of this particular project. Also, another question is our dual payload ADC development progress, right? We actually have a dual payload right now. It's in enabling study trials sort of progress. By first half, by Q1 next year, we're going to actually submit for approval. My next question is that when you look at the first half of the year, your sales expenses are relatively lower, you know, for a company that just launched their commercialization project for the first year.
As was mentioned during the previous earnings call, your parent company can give you a lot of empowerment and synergy when it comes to penetrating lower-tier cities. Can you elaborate on that? Actually, Mr. Ding mentioned that for lower-tier markets, you know, you plan to actually use a whole basket kind of strategy when you launch the sales force into it, workforce into it. It's not like the top 100 hospitals strategy, right? Can you elaborate on how your parent company can help you to do it better? Also, PL1 and also your commercialized drugs, right, for TMT, you know, right now, we don't see a lot of sales performance yet. For drugs that are not so innovative or unique in the market, how do people, how does the market perceive it? The first question, I think, Mr. Ding, because it's related to our sales and commercialization.
The synergy between us and our parent company is about market access and also commercialization channels because Kelun Biotech, you know, we are very specific. Also, we're very focused on oncology drugs development. For the product 140, as you've seen from our announcement, we actually commissioned it to Kelun, one of their teams, to promote it. We are participating very proactively in the medical insurance coverage of the country. Hopefully, after it got approval into the medical insurance coverage and catalog, we can quickly increase the sales volume. For this kind of oncology, for example, GI-related indication, we are going to rely on our parent company's distribution channel. For ourselves, we're going to focus on a lot of oncology indications such as lung cancer, TNBC, and others that our 264 and 167 are focused on.
Also, this year, we initiated some projects, the combo therapy of using 315 on gastric cancer. Going forward, we believe that combo therapy, especially leveraging PD-L1 as a component, is going to generate a lot of market opportunity for us. Got it. We would like to actually switch to the online participants. Following the order of hand-raising, we're going to give the first opportunity to Wang Yan Ding. Can you hear me? Yes, we can. Good evening, everyone. Very, very happy. Thank you so much for giving me the opportunity to ask the first question online. We can see that a lot of MNC overseas, including MSD and also Pfizer, actually invested in some P1 and bi-specific assets. A lot of MNCs said that they are going to use these new assets to do combo therapy with ADC. It looks like this is the market trend going forward.
Clinically speaking, how do you perceive this opportunity or trend? So far, any kind of consideration when it comes to clinical trial design? This is the first part of my question. The second one is that Dr. Jin talks about clinical trial development. We actually have a lot of first-line trial three trials. Let me just confirm with you. Can you confirm with us that, you know, Keytruda in China, you know, especially for wild-type lung cancer, trial, sorry, phase three progress? Can you report on that? I think I missed that part during your presentation.
Got it. I think these two questions are closely related to our clinical parts, right? For example, our ADC IOF bi-specific. The second question is Keytruda combining, you know, with our drugs in China for wild-type lung cancer clinical trial development.
Thank you for the question. The first one regarding the market trend or industry trends, yes, indeed. We saw that large players such as MSD, Pfizer, etc., these MNCs have all invested in, for example, bi-specific and other related assets for also combo therapy with ADC. You can see two things. The first one, the two reasons. The first one is because data, you know, you can see that OES with Keytruda have achieved 0.78, which is clinically meaningful, meaning that bi-specific, by comparison with monotherapy of PD-L1, I mean, is actually more effective. Also, you can see for our 12-2 ADC with our own PD-L1 in first line has achieved 15 months, right, which goes beyond PD-1 plus chemotherapy. We also have a lot of other data that supported the result, supported the conclusion that ADC, you know, using combined combo therapy is much better than using PD-L1 alone.
People have high hopes for ADC combining, you know, IO bi-specific. I think this is going to be a big trend, especially for lung cancer, you know, treatment, you know, for the coming five to six years. It's not just for lung cancer alone. I think it's going to apply to many large indications, other kinds of cancers. That is why MNCs are proactively, you know, developing groundwork for this new trend. For example, with immunotherapy, bi-specific, etc. I think going forward, we can have, we will hear a lot more about this with dual payload, with bi-specific, with ADC, etc. Regarding that, we, together with MSD, are also preparing for future development. In the future, we can use combo therapy. We can use ADC pipeline together with our own pipeline. The second question, sorry, I did forget to mention this in my presentation.
Actually, when it comes to first-line treatment, actually, wild-type, yes, non-small cell lung cancer is also one of our key focuses as well. We already have two projects in development. One of them has already finished the patient enrollment. This year, we can finish NDA. Also, for negative patients, we also are enrolling patients of that type. Hopefully, you know, the enrollment has finished half already by the end of the year and maybe the beginning of next year, we can actually finish patient enrollment. Thank you. Bi-specific and also all kinds of combo therapy, you know, with ADC, you know, I think everyone believes that there are a lot of opportunities out there. I think it's going to generate more clinical, you know, better clinical value and data. We are still exploring, right? Is it bi-specific plus ADC or IO bi-specific plus ADC or mono-specific ADC?
It depends on the combination, right? Which one actually can achieve better results? Because for ADC and even for bi-specific ADC, there are different payloads, right? I think everyone is still exploring, doing different kinds of methods to test out the best result. We are still undecided on which combination is most suitable for which indication. It has to be determined.
Next question. My question is that for 264 phase three lung cancer, right, you mentioned PDL1 positive, PDL1 negative lung cancer in China is now developing very fast for phase three. We also see wild-type phase three. We would like to understand the rationale behind this clinical trial design. Also, for PDL1, you know, negative and positive patients, I think right now the treatment coverage is really, really comprehensive. Why do we have to launch a phase three wild-type clinical trial using your own PDL1? Sorry.
Maybe I got it wrong, s et me just correct myself. It's not phase three. It's actually phase two. Thank you for the correction. My question is that this year, apart from 264, you have other commercialization products, and their sales revenue is smaller. 264, obviously, $300 million for the first half is really good. The question is that before that, do you have any limitation or constraint from your production capacity? If you had more capacity, would you say that your sales revenue could have been higher for 264? In the future, do you feel like the market has higher demand? I understand that you have two questions, right? Basically, the first one is about our two other products, commercialized products, apart from 264. Mr. Ding, maybe you can address that. The second question, the other question is about the production capacity of 264, right? Dr. Gu is going to address that. Mr. Ding? Actually, Dr. Gu is going to take both of these questions.
Let me talk about the capacity first, whether or not capacity is limiting our sales revenue. I would say that, first of all, these three commercialized products are not being limited by the capacity of production for 167 and 140. 167, right now, the sales revenue, I mean, this is not our focus yet because we are still forming our sales team and because we are not promoting this indication that much. I think that we are waiting for the right timing to do it once the combo therapy is ready. Another thing regarding 140, first of all, we are in the process of getting into the medical insurance coverage catalog. We also are collaborating with our parent company. We are commissioning our distributors to do it.
This year, we're going into the catalog. By next year, hopefully, our 140 can increase their mass production volume once we finish all of the protocol. When it comes to capacity planning, I think overall, they are matching the sales revenue expectation, and also w e received a lot of support as well, policy support, etc. Apart from 167, 140, 264, we have definitely backup suppliers or producers just to make sure that, you know, once anything happens, if anything happened, we still have a backup plan. Right now, we are just in the process of verification of technology transfer for our potential producers. For 140, you actually can look forward to next year once we finish getting into the medical insurance coverage. I think the sales volume will definitely explode.
My next question is twofold. The first one is about policy. As you can see, the government has given a lot of support for innovative drugs. Lately, the government also has launched a new catalog or a new draft of innovative drugs guideline as well. For this year and for 264 and also in the future, what is your strategy of going into the medical insurance catalog? How is it going to impact your product sales strategy going forward? The second question is that lately, we have heard some discussion regarding your IP disputes. Can you also address that? The first one is about policy of innovative drugs and also market access, right? Dr. Gu, Dr. Wei? Thank you.
This government's new medical insurance policy is very update, and so y ou can see that we have already studied very hard on the new policy. This year, you can see that 121 types of products have submitted their application and declared that they want to go into that kind of new policy coverage. For our strategy, our strategy is to prioritize going into the medical insurance coverage catalog because every year, in China, every province is doing their thing to push forward the implementation of the new policy. Right now, we do not have absolute certainty about the future implementation of the policy. We are now quickly following and being compliant with the policy, making sure that we are preparing ourselves to go into the medical insurance. Now, about the policy, Dr. Gu is trying to add some comments. First of all, the government has given a lot of support for innovative drugs development, t hat is obviously being seen, but then t here is not a lot of certainty or visibility about how this policy is being implemented.
Hopefully, we really want to see this kind of implementation or clear interpretation and explanation of the guideline and policy come out as soon as possible so that we can have better understanding. Since last year, we already have seen more and more support from the government regarding pricing of innovative drugs and also renewal of contracts of innovative drugs, etcetera. These are really, really exciting good news for us.
The second question, very, very specific. Thank you, David, for asking that question. That means that you really have done your research. Indeed, there are some IP disputes for several founders of this company, this biotech company. We have already initiated a lawsuit against these several founders of this particular company, and also w e have sued them to the Sichuan Provincial High Court. The High Court has officially accepted the lawsuit for review.
At the same time, the relevant public security organs have also formally filed a case in this forum as well. Obviously, our company is the pursuant. It is not going to affect, I mean, this legal case, this lawsuit is not going to affect our operation because we are not in the faults. The details of this lawsuit are confidential. Forgive me for not being able to disclose more information.
Thank you for allowing me to ask my next question. The first one is about HR positive and HER2 negative breast cancer. I would like to ask about this clinical trial. Actually, some of your peers have tried that, but the trials have failed. Do you think, I mean, what's your expectation? What do you think, what kind of data do you think can be generated that can be competitive enough in the market?
You know, why do you think this kind of clinical trial can help you to generate the targeted OES to make it more significant and meaningful? This question is about our second-line lung cancer phase three clinical trial. Dr. Jin, would you like to take that?
As was mentioned in my presentation, this year in ESMO, we probably will have two phase three readouts, data readouts. As we mentioned, Dr. Gu also mentioned this. Based on our interim results, we haven't published it, but we already submitted CDE, and so e verything is going really well. It has progressed really smoothly. What kind of standards should we be looking at, right? For lung cancer, everyone's looking for OES, right? OES is one key performance target because our. Our
OS right now is, on average, really low. People really value and prioritize extending the OS, whether or not this drug can stand up. PFS is not enough. You need to extend the OS. In ASCO this year, hopefully for our third line, together with combo therapy, we have achieved already very good results. We have already achieved 0.4 plus, that kind of result. Also for our third line, hopefully that kind of result can be represented in our second line, you know, phase three trials too, y ou can look forward to our data readout. For breast cancer, especially for HR positive, HER2 negative, typically OS is very long, y ou have to have long enough follow-ups to see OS results. From early data readouts, you can already see that TNBC OS is actually, even though the OS is shorter, we still see very good results.
We already see that overall, I would say that for our TROPE2 ADC in lung cancer, based on published data, OS definitely is very obviously better than others. We definitely look forward to our upcoming reports and publications for our large scale phase three trial results. We believe that you can expect to see very good OS improvements.
Got it. Thank you.
want to follow up?
Hi, I'm Huang Yang from JPMorgan.
I would like to ask a question regarding lung cancer. You already have the third line PFS ratio and OS, you know, both of them are really good. Would it be difficult to actually replicate that in second line? Obviously you can beat standard care, but it would be more challenging for it to actually deliver the same kind of results in second line compared to third line, right? The PFS and OS, right? Typically, they are higher than third line, Dr. Jin?
Usually, yes, that's the case. For second line, you can see the data, I mean, you can see public data, right? The control group is 14 months, and the experiment group is 17 months. Also, the PFS is 0.8. The control group is actually 14 months, very, very long.
In order to improve that, I mean, go higher than that is actually very hard, very challenging. That doesn't mean it's impossible. If you look at BS8201, HER2 ADC, I mean, the result is very good. Even for a second line, first line, they still generate very good OS ratio. Also, for Johnson & Johnson's combo therapy, in second line and first line, they see at least 12 months for the OS. You can see that even though it's challenging, if the drug, you know, mechanism, MOA, et cetera, I mean, everything hits the mark, very innovative, very differentiated, we believe that there is still a chance for drugs to generate better OS. I think for us, on data medicine and also for BMG, we already published our EGFR miltin type, you know, our resistance patients.
Also, for our MOA, you know, it's actually pretty good for this type of patient group. We look forward to present the phase three results on ESMO this year
[Foreign langauge] Now my next question is that you mentioned you have three first line implications, you know, that you are going to submit NDA for. That includes two lung cancers. Next year, are you going to have data readouts for pancreatic cancer? If so, do you think that lung cancer, next year, do you think you're going to have maybe three lung cancer indications? Dr. Jin, the question is about our first line clinical trials and also data readout kind of timeline.
[Foreign langauge] As I mentioned in my presentation, in TPS larger than 1, wild type EGFR, sorry, non-small cell lung cancer, I think we can expect NDA. If everything goes well next year, maybe we can catch the timeline to present the results. For first line TNBC and also first line non-small cell lung cancer, maybe later next year in ESMO, we can present the data results.
[Foreign langauge] Now, obviously, their event research, I think they should have been able to present the data readout end of this year. I think it got pushed to next year, maybe later. I think that Dato also has several studies. I think they have already been doing it for quite a while in first line. The difference is that, first of all, they actually use combo therapy with Pembro and also Dura, and also they use chemotherapy as part of the combo components. For us, we just target the positive patient group, which is to do without chemotherapy as a treatment. We can actually compare with the combo therapy with Pembro.
[Foreign Langauge] Our combo therapy with PD-1 in early stages, the results were quite good. It's ADC plus PD-1. Our PFS is pretty good. Yasin, you have another question?
Yeah, just a tiny question. For first line TNBC, you know, I think it's monotherapy, but MSD is a combo therapy with Keytruda. Your domestic and international treatment are different. Do you think there are conflicts? They would generate conflicts. In the future, will you consider using combo therapy for first line TNBC? This is a very good question. Targeting the domestic market, we mainly use monotherapy for PD-1 negative patient groups by comparison with chemotherapy. We can finish patient enrollment by September this year. Hopefully, by the beginning of next year, we can finish NDA and we can get approval, which is way earlier than the global development. For MSD, obviously, global is their main market.
In the beginning, we actually have explored both monotherapy and also combo therapy. Hopefully, combo therapy can improve our PFS and OS. That's why MSD has launched a 3B study. Basically, this is a three-line study including Keytruda, etc., and also by comparison with chemotherapy to see if they can extend the PFS and OS. Obviously, our ultimate data will be shared with MSD and also MSD's global trial. We will need to enroll Chinese patients for their phase three too. We can further look at the data to see, you know, combo therapy, whether or not combo therapy is actually stronger and better than monotherapy. Regardless, China, because we already are in the process of doing the NDA, I think it's actually earlier and sooner than global results. I think we have already gone beyond the hour. I think we will have time for only one last question.
I think Li Luo from the line, from online.
[Foreign langauge]
Great. Thank you for taking my question. Hi, I am from Guoya, Mingsheng. My question is for SKB264, this bispecific ADC. In the future, if you are trying to target indications, what are the indications that you are going to target at? Because based on our current research, Johnson & Johnson's bispecific, they are looking at GI-related oncology, for example, really large colorectal, etc., and digestive tract tumors. There is also a lot of possibility of developing drug resistance to this kind of bispecific drugs. When we look at first line of colorectal cancer, you know, there are chemotherapy already, and there are some treatments that have actually higher OS. The second question is what is your design advantages by comparison with Johnson & Johnson's bispecific drugs? What is your differentiation and improvement on that? What is the timeline of the development?
Do you think this year we will be able to go into phase three trial?
Thank you for the question. For our bispecific drug and also the mechanism and also the structure of the target, unfortunately, we cannot disclose information. This obviously is very confidential. If you look at our IP, the patent, it's definitely more than just one single traditional structure. There have been a lot of rumors right now in the market. Maybe Dr. Jin can talk about the pipeline planning and timeline. Now, about 571, our positioning is not in late line because ADC in late line treatment, you know, it's not a good market. We definitely need to go into early line treatment, for example, first line and even in early lines.
First of all, the difference between 571 with SKB264 is that we learned a lot from the development of SKB264, so we are able to improve the safety profile of this 571. As a result, it really benefits from combining with TKI, PD-1, or chemotherapy. The results by comparison with SKB264, it will be more suitable for combo therapy with our bispecific and TKI and chemotherapy, PD-1. That is why we can really prepare for first line treatment. By comparison with Aventa, which is made by Johnson & Johnson, first of all, our safety profile and also our toxicity, I think both of these, especially the safety profile, is better than Aventa. When it comes to indication, we're going to focus on non-small cell lung cancer.
I mean, lung cancer, there are a lot of drugs in the market, but there are still a lot of unmet needs that we can tackle. There is a lot of potential still for lung cancer as well. For example, we can actually have more targeted patients and early line treatment, early intervention, combo therapy, et cetera. Lung cancer will still be one of our biggest indications to target at. Apart from lung cancer, we also are going to build some differentiation. For example, SKB264, we really did not focus on GI. We focused on lung cancer, breast cancer. Going forward, I think for 571, we can look at early line treatments of other oncology, such as UI, et cetera. As we mentioned, we have already entered phase two. We are going to explore, for example, monotherapy, combo therapy.
Hopefully, with SKB264's experience, we can speed up the process of developing 571. Very clear. Thank you.
[Foreign langauge] Got it.
I think I know a lot of you still have questions that you want to ask, but unfortunately, we are running out of time. We will continue answering your questions offline. We are kicking off the interim results roadshow across different cities. If you're interested, please make sure you get in touch. Thank you so much for joining tonight's interim results presentation meeting. We definitely are grateful for your support. We will continue to develop and uphold our mission and vision so that we can continue to innovate. Every year or every six months, we can actually publish new developments that are exciting for you all. Dr. Jin, would you like to say some final words? That's all. Thank you. Thank you so much for joining.