Nanjing Leads Biolabs Co., Ltd. (HKG:9887)
39.08
+1.40 (3.72%)
Nov 10, 2026, 4:08 PM HKT
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Earnings Call: H2 2025
Mar 27, 2026
Summary
2025 revenue was CNY 177m, with higher R&D spending and a narrower pre-tax loss; cash reserves reached CNY 1.548bn. The key 2026 milestone is an LBL-024 BLA submission targeted for Q3, alongside expanded clinical and BD activity.
Hello, everyone. Welcome to Leads Biolabs 2025 Annual Performance Conference. All participants are currently muted. I will now read out the statement. This meeting is for investors only. Audio and written records are for internal use and may not be published, reproduced, or distributed. Leads Biolabs has not authorized any media to report content for this meeting, and unauthorized reproduction or sharing constitute infringement. Leads Biolabs reserves the right to pursue legal liability and shall not be responsible for any losses arising from unauthorized reposting. Markets are risky, and investments are subject to actions. Caution: Investors are advised to make prudent investment decisions. Please note that a Q&A session will follow the presentation. Now I will hand over to the moderator. Thank you. Distinguished analysts and investors, good morning. Thank you for all of you to come to our Leads Biolabs 2025 performance conference this golden Monday morning.
I am the Citic Securities, and for the pharmaceutical researchers and analysts at Anfi, and we also got our colleagues and Dr. Chung Yin from our securities. For this conference, also get the support from different securities. For example, CICC, and Huatai, and CMBI, et cetera. The person who present together with me is the Chief Medical Officer, Mr. Cai, and our Chairman and the CEO, Dr. Kang, and our Secretary and the CFO, Dr. Zuo, and also for the IR responsible person officer, Madam Hu. I believe that the trust is the most important thing for the briefing, and we prepare a very rich, full report. Next, I would like to give the floor to Mr. Kang. Thank you, all of you, to departing to our Monday morning 2025 performance conference. Today, we will mainly cover four aspects. First is the business progress.
I will take it. Then for clinical progress will be presented by Dr. Cai. Then for CFO with a financial briefing, which will deliver to our CFO. I am so happy to be here and really looking forward for this presentation so that you can have a good idea about 2025 business progress. First of all, I would like to share about the business development. We are a global frontrunner in next-generation immuno-oncological treatment. As already introduced to all of you, there are several stages for our company's development. First is 2015 to 2019. We established our technical foundation, mainly focused on the preclinical stages for the assets or products. Then come to 2020 to 2024, which is more like a clinical exploration stages. Right now, there are six products at the different stages for clinical area.
The fastest-growing is a PD-1 4-1BB, for LBL-024, which is at the registration stage. For this project, we get an NMPA, a breakthrough like FDA FTD and the ODD. We also get the NMPA BTD. Since you know that we are listed in the Hong Kong Stock Exchange, which is a very successful issuing, nearly US$200 million offerings. Looking for the future, we are confident that there will be fruitful achievement for 2024, which is a more general and have a full coverage of these solid tumors and cancers, and 34 is also one of the best-in-class pharmaceuticals. Based on the clinical data, we see that there is very good results. We get our own platform. I can introduce you more details about this platform. Based on the platform, there will be the iteration of different types of products.
We will choose 3 to 5 special products that are promoted to the MMD stages based on their unique characteristics. For the IO immuno-oncology, we think that the treatment needs a diversified infusion of a different platform for us. We got 3 types of different platforms. At the very beginning, we focus on the same immuno-oncology 2.0, IO 2.0, mainly focus on 4-1BB. The characteristics is that it is not just the changes of the numbers or the qualities of the T cells. They also help to the proliferation of the T cells. Characteristics is with the special conditional activations, which avoids the toxicities, hepatotoxicities, and maximize the activations for the T cells. For LBL-034 and GPRC5D/CD3 is an also very good platform for TCE platform. It is also conditional activations. It shows very good excellent safety levels and efficacies for the multiple myeloma.
Besides that, for ADC, we work on it for long period times. It is not the most leading part in the forefront in all of our fields, but equally special attributes and characteristics. I am going to show you the advantages later on. Right now, we are mainly focused on some drug resistance issues for this ADC, which is a big challenge. For example, now we try to combine all these treatment methods together. For example, ADC complying with the CDE right now. This year, we call T-application projects is LBL-054 projects. For this page, you could see it is mainly the product pipeline updates. Because time is limited, I will not come to more details about all these pipelines, but I could share about the strategy and logic. LBL-024 is a cornerstone item. So are the projects, especially for the core tumor, and its performance is much better than PD-1.
The OS shows also good results, which is different from the bispecific antibodies. We would like to show the differentiations, especially for LBL-024. We submit a BLA T with the NMPA by the Q3 2026. It also shows very good safety level efficacies for the SCLC, NSCLC, and for LBL-034, we think is a best-in-class TCE, and Dr. Cai is going to show you more details about this part. We are going to start our clinical trials in 4 different durations. Next page, I will not come up with more details about each item. We already put this post on our official website. If you are interested, feel free to check about that, no matter whether ADC or TCE. We try to realize and combine therapeutic to realize better results, no matter PD-L1 and the anti-specific antibody.
They also provide a good treatment that we think is a very superior platforms, but we think they are always the best one or the better one. We think the next generation, LBL-024 and LBL-034, will iterate very well. Here we see for the autoimmune sectors, we also got very good results and get the recognition, especially for overseas, which achieve the good results for the autoimmune sectors. Here I would like to update the major business. First is about the financial capital market updates. As you all know that we got listed with the Hong Kong IPO, got nearly US$200 million for more investment and development. We see the retail oversubscribed by almost 3,500 times. The institutional oversubscription, as you can see, investors by 40 times, and was included in the Hong Kong Stock Connect and the Hang Seng Composite Index.
Also including MSCI, the Global Small Cap Indexes in November 2025, which is a kind of recognition from the market. It impacts LBL-024, which we focus on expanding and exploration for it and to see more indications about that. We submitted the BLA. Last year in our half-year R&D meeting, we also presented our initial data. For example, like the 88% ORR. Then for NSCLC, which is 50% for OR. We are looking for that in the future, we could get more opportunity and diversified ways to show you our clinical data or result. LBL-034, last year, we also did our report. Generally speaking, it is pretty safe, and we already come to a very good result, and the ORR is almost 90%. The efficacy is similar as a CAR-T result.
A similar result as a CAR-T at the phase II study. We are trying to promote it. Hopefully, we could come to the critical pivotal clinical study for the clinical assets. I will give you more declaration about that part. We got a very rich preclinical assets. It is not simplified to elaborated. It is more unique characteristics. We got two BD deals. One is Aditum, one is a trans-bispecific antibody. One is for an autoimmune part. For the preclinical assets, which is rich for, I will not come up with each one of it. One is LBL-054, which is a target for CDH17. As you can see here, CD3 and PCD3, we call it comes to the TCE stages. LBL-076 and CD38 is a bispecific antibody. It is not just for the poster stages, also got potential for the early stages.
LBL-066 is iterations for LBL-024, and we believe that there will be the better efficacy compared with the other previous generations. We have shown these super priorities, and we hope they will be the better advantages. That is also our vision. We focus on the innovation. We would like to implement it into our reactions. For PD-1 products, we would like to really share with the clinical part and the benefit by our patients. Thank you. Thanks for Dr. Tan's introduction. Just now, Dr. Tan shared with our platforms and next stages and development progress. Next, I would like to share with you the several important assets that already coming into the clinical stages and the next stage plan. First is our core products, LBL-024, PD-L1/4-1BB bispecific antibody. First, I would like to share several progress.
For end of 2025, we already focused on the 13 solid tumor indications and started the explorations. There are already 600 cases or patients. Until now, there will be more patients enrolled. For the early stages indications, we have a long-term follow-up. We see very good OS benefits gained by the patients, which lay the foundation for next generation anti-cancer cornerstones for this anti-cancer drugs. This year, we would like to expand more indications. Based on the data we see is already kind of ripe and mature. I would like to share several major indications. First is the second line and third line, phase I, phase II, and for the development of the LBL-024 for EP-NEC, it developed very well, and they will get very good development for 33.3. We would like to submit it at the international peer review journals or international summit.
The second part is the single arm and the dual arm registration study. Last year, we completed about the enrollment 4 and a half months before with 96 patients. This year, we are going to submit the BLA for the third quarter this year. We really appreciate the trust for our patients. We will have the confirmatory clinical studies, which means for the first line, EP-NEC for the phase II, we already completed. For the overseas, it is not mature yet. We still need to follow up. Last year at the ASCO, we have oral presentations about our initial efficacy. This year, we will submit phase III clinical confirmatory study and phase III clinical studies for SCLC. We have a random control against the atezolizumab plus chemotherapy. We checked about the data already presented last year for the oral.
This year, we are going to also give the submissions for the key conferences to give up a new updates about the data. For NSCLC, we also do the combine and have involvement of other 100 cases. Last year, we got part of the data, and this year, hopefully, we can continue the updates about these datas. For 2024, which as I mentioned just now, we submitted that for LBL-034 and GPRC5D/CD3. When we talk about the order, we are number 2, the second most clinically advanced TCE T-cell engager globally. When you consider about the TCE, we are definitely the most advanced because we solved about next generation therapy or treatment, because we solve a very key and important issues, which is safety and efficacy and drug quality, et cetera. These are very big challenges, especially for the survival rate or response rate, et cetera.
Besides that, we also obtained the ODD from the FDA in October 2024 and the FTD from the FDA in January 2026. Because of our unique structure design, reduced the levels of CRS. We also gave oral presentations at the ABIC conference last year for the ASH annual meeting. For the phase II, we are going to have four subquery expansions. For example, as you can see, we have different groups, like different groups of patients, like EMD subgroups or BCMA-related subgroups, and with the good results achieved for the ORR. For LBL-007, as you can see, we have two publications last year, and published in Journal of Hematology & Oncology in February 2025. At later stage, we are going to try to expand the general layout. Last year, we had the FDA and the CDE. At 047, the approval for the R&D, approval received.
This is a first-in-class autoimmune dual mechanisms pharmaceuticals. We already see there is a very confident and early encouraging signals that achieved, and we are going to continue the clinical explorations. So the first indication as listed here. For LBL-024, there are so many indications. How do we deploy? We put them into different tiers. We got three tiers. Tier 1, as you can see, we want to be the first-in-class, all of the indications, and first to the market to become the first approval drugs, especially for the target or mechanisms. Make sure it could focus on the EP-NEC and the mono treatment. The treatment line is third line. The second tier, we try to focus on the SCLC, NSCLC, or BTC cancer to make sure that it could focus on high potential indications, have the broad deployment.
Third tier is exploratory indications for the signal seekings. I will not come up with more details of that. It is not just related with the order. The key point, we hope that it could, in the more fast and efficient way, share the benefits with all of our patients and bring the better value for the market and the patients. Next, I would like to share about the LBL-024, the development prospects in NSCLC. There are four arms for the NSCLC development. Line 1, line 2, and non-squamous carcinoma, et cetera, for different coverage. We would like to check for two supports, whether it is effective and whether it could reverse the drug resistance issues. Then we would like to explore the next-generation standard of care compared with existing associate, whether there is a better efficacy.
We would also like to explore and validate whether there could be a next immediate or timely use of drugs. For the IO 2.0 explorations, early-stage study results, we already have our initial presentations. We are going to share the updated results later on. Generally speaking, for LBL-024, based on the initial data, we got very safety results, and solved problems about the irAE hepatotoxicity issues, which shows very good tolerability in the safety and durability. Besides that, a very lucky indication. For other indications like NSCLC, this type of indication, we see very good result for the later stages. It could be used for the cold tumor, especially for the ovary cancer, et cetera, or melanoma, ovary cancer or bile duct cancer, BTC, et cetera. It could be sort of a very effective treatment for the cold tumors.
Besides that, we see the survival time has been significantly extended and prolonged. For the treatment and for the other indications, we are going to show the result for next important conference. Generally speaking, LBL-024 with the unique mechanisms for actions, it shows very good results with great potential. Next, I wanted to share about several highlights for LBL-034. Based on unique design from the efficacy and safety, we have shown excellent result and superiority compared with the last generation. First, as you can see, for ORR and for the safety and the security, especially for the consistent. It solved the big problems of the skin disorders and taste disorders. Some of the issues more is like a transient. It could be easily solved. It could be a next generation targeted blockbuster therapeutic drugs.
We also come to the FTD, get the FTD by the FDA. As you can see, we also expanded to the other indications like RRMM, multiple myeloma. We also conduct and developed for some BCMA failed or treated therapies for EMD or the PCL patients. For the major near-term milestones, as we can see, for 2024. First, third quarter, we will have the BLA submission to NMPA. Hopefully next year we will get approval. Second, for first-line EP/NEC, we started a phase III study, random controlled clinical study. Next one is about the SCLC. We will give the oral presentations for NSCLC. We are also going to give the oral data update, the initial data for key important conferences. For the other indications, phase II, we also would like to share the updates.
For LBL-034, except for updates of the data, we communicated with the regulatory and supervision officers to start the further clinical studies. They gave the disclosure for these international conferences or journals. Hope you could continue to pay attention to our progress. Thank you. The third part is the financial progress. First is about the P&L. Consolidated statements for profits or loss. From the revenue perspective, we got very good results in 2025. We got CNY 177 million revenues. For the cost and the expenditures, we expanded the R&D. As you can see, the R&D increment, which is shown here, because we focus on the indication applications for '24 and bid for more new expansions. Therefore, we hope that this R&D investment could bring better results and returns.
For the losses, as you can see, there is a change for the losses before the tax, a change of CNY 195.9 million, changes from CNY 301.2 million. Definitely, there are very good fruitful results achieved in the form of good cycles to make sure we continue to generate a steady revenue increase on R&D investment. While controlling other costs, we ensure that the loss is in a relatively small and controllable state. If we would like to highlight something, we would like to take a look at the highlights for the financial report. Four aspects. First is the revenue in 2024. As you can see, we generated about CNY 177 million in 2025. This is because of our continuous business environment transaction development.
For the R&D cost, it rose to CNY 289 million from CNY 185 million. Because of a large investment, good results are achieved because of continuous progressing. From the assets perspective, I would like to mention the cash and the highly liquid financial assets. The proportion for this part is very high. It increased from 80% in 2024 to 87% in 2025, which shows that we focus more on the asset-light nature for our companies. The last part is about the cash reserves or cash run rate. We rose from CNY 538 million to CNY 1,548 million. There is a 187% increase concerning about the non-operating losses we just mentioned, which is only CNY 180 million. This reserve is sufficient enough for the cash flow. We can cover our operating needs at least for four years. So that's the main four highlights I would like to mention.
In the end, I wanted to share about the business outlook for our company. Generally speaking, our business developed better and better. First is the LBL-024, which is a pan-cancer cornerstone therapy. We will submit a BLA in Q3 this year. We will also like to talk about the efficacy and securities in the other indications. We have the global deployment. We have the EMA, FDA, ODD, and the fast track FTD, and try to expand it to the global market. This is really a cornerstone asset. Second, based on our three technical bases, we not really just rely on original technologies. We would like to iterate and expand it, and improve, and enhance the safety and the efficacy. Based on this platform, we could have a next-generation innovative product. In the long perspective, we keep doing innovation.
There will be 3 to 5 assets that will come to the R&D, and this is definitely a master development way to make sure it is competitive. This is also characteristics for us. We focus on the clinical pain points, the solving unmet needs, and continuously maintain our leadership roles in the industry. From a business perspective, we focus on the light assets operating model and based on our existing assets for the existing capitals, work together with the CDMO to make sure we maintain the asset-light structure. I believe you also noticed that for a product, if it works with a CDMO, it works well. But later on, if you have got 3 to 5 clinical assets or products, you should have your own capacity. Therefore, we also have the deployment of the production capacity to make sure it is moderately expanded.
For the BD strategy development, we already achieved the initial results last year, and this year, we are going to continue to focus more on it. There will be better achievements, not just the Chinese market. More importantly is overseas MNC companies. Looking for the future, for 2026. As you can see, from 2025, we have got only 4 clinical products and 20 plus pipeline candidates. Next year, we hope there is 1 commercialized product and 2 to 4 late clinical stages products. Next year, there will be 3 to 5 IND per year. For 2030, there will be 3 commercialized products and 4 to 8 late clinical stages products. For IPO, we already have the transformative changes or fundamental changes, which means that we have sufficient resources. It is not just related with the capital perspective, also the product accumulation, the talent support, et cetera.
I am so confident about that. Based on the platform, I would like to show my appreciation to all the support from the investors and the senior analysts. We are looking forward for more opportunities for the better communication with all of you. We believe that for Leads Biolabs, we are working on it. China innovative drug already come to a golden stages for the development for Leads Biolabs. We will continue to play our role in it. Thank you. Then come to Q&A session. Thank you, Professor Kang, Professor Tai, for your sharing. Next thing, the Q&A. Can you hear our questions? Hello, everyone. If you have any questions, feel free to participant into the mobile phone, please press the star key on your phone and then press the number 1.
For the online participant, you could type your question on the live chat box or please raise a hand button to request to speak. Fei from Citi. I would like to ask a small question. You see that LBL-024? Can you hear me? Yeah. It is pretty clear. Okay. For LBL-024, it shows very positive, very encouraging signals for efficacy at the early stages. We also see from the company perspective, there is expansion of the indications. I would like to ask that when we did expansion of indications for the SCLC and NSCLC, when you did expansions, when we use the IO 2.0 and ADC, how about the company's future strategy development plan for this kind of combination of IO 2.0 and the ADC? Thank you. Dr. Tai. Seems that there are some technical issues, but now back to normal.
For next generation, no matter whether SCLC or NSCLC treatment, first, we think about the standard of care. Secondly, the future SOC. The third option is our own pipeline combination. This kind of balance result, the purpose is to find more effective solution that could really solve the problems of the patients. The first options, which is what we are testing now, where we are doing the clinical studies, is a chemo plus LBL-024 and a plus PD-1, PD-1 combined with the chemo. This is one of the clinical studies, clinical trial. Another trial is working from PD-L1 and combined with the ADC, this is another option. The third one is our own pipelines, as we can already see, for next generation, this target has a lot of potential. The fast-track possibilities is also innovative solutions for these combinations and the future development strategies.
These are three ideas or directions. Thank you. Thanks for Dr. Zhang Shaoring. Next, let's welcome the analyst from CICC. Hello, everyone. Can you hear me? Yeah. I would like to ask two more detailed questions about the SCLC and NSCLC. First, SCLC, we already see that for the second line and the first line, there is a good result, initial results with 100 patients enrolled. How about the enrollment scales for the first line, second line? If it could be enrolled for this year's second quarter? If it's possible for the World Conference on Lung Cancer, last year, if we disclose a number, what is the disclosed sample number? If we reach the initial PFS results or data, can you share our advantages for our PFS based on the resistance status score? Another aspect is about the first-line SCLC.
We are estimated to disclose the initial OS data for ESMO. We're going to share this data for PFS and OS at the same time? Simply speaking, for the NSCLC line 1, line 2, LBL-024, 100 patients enrolled. If I remember right, for the second line, 55 patients. First line, there's 60 patients. All together, 110 patients enrolled. For this disclosure, we're still discussing for the final stage. We're discussing with our relating PI to see for WCLC, for this conference, which data that we will disclose. We will check the ORR and biomarker relevancy for all this data related with the biomarker, et cetera. For this official meeting, PFS is relatively immature, is relatively immature, but definitely, we're going to give a general trend of it.
Generally speaking, that's the main idea, but it really depends on the progress for the whole project and the observation of our data. For the NSCLC, we are planning to do an oral presentation live, a presentation on ESMO and report. The data collection should be completed in August. It's relatively mature. Then we're going to give the disclosure of the OS and the PFS. Thank you. Thank you. Thank you for your answer. One more question. Next, we would like to invite the analyst from Dongfang Securities, Oriental Securities. Thank you. Thanks for time, Mr. Cai and Dr. Zhou, who gave me this opportunity to ask the question. We see that for LBL-024, except for the normal diseases indications, there are some POC diseases. For the other indications, are there any new plans for that, for these other indications of LBL-024 and corresponding R&D expenditures?
Constantly considering about the early stages results for the studies for LBL-024, LBL-034, what is the R&D expenditures annually? I can answer the first question, and Dr. Zhou will answer the second one. For the early stages in our slides, we list a priority and the tiers. The first tier is listed as the IPO, and the others is going on the same time. Tier 2 is mainly for the SCLC, MBC, all the other indications, et cetera. The reason why we are listing this way, because it progress very fast. We already witnessed the encouraging initial results. Therefore, these are definitely our priority, and then we are concerned about the phase III clinical trials design. As for the other indications, we have several patients enrolled.
Because it is so early, and we cannot really elaborate on it, but we really see that for some hypothesis about the cold tumors, there is very good results and a very good trend for these hot tumors. Therefore, we are going to follow this order to collect the subsequent data and start phase III clinical trials. That is the general arrangement. As we can see, for 2026, we got 13 patients progressing. Last year, we got CNY 300 million for the budget, and this year we are going to increase a little bit, which is sufficient enough, which shows that for the R&D, clinical efficiency perspective is very high. R&D and we are done in-house, and for operation, same things. We have our own team. Therefore, you see in the whole industry, we call very efficient progress for each sector. Next year, we will have some indications that come to phase III clinical trials.
We have the sufficient funds to support the second. The BD income, like revenues, is now in the period of acceleration growth every year, and it says to me that next year, the BD revenue will keep rising. When we talked about the cornerstone or the milestone payment, it is already in the pipeline, so in terms of efficient increment and significant revenue growth, we have no issues with the domestic phase for clinical trials, and we can proceed without any problems while ensuring the financial stability. As for the international trials, we also actively pursue the BD for the phase III clinical trials overseas, including the other indications, like phase II clinical trials. Once the data is mature, we will again issue the BD activities and give the disclosure. We work together with the global MNCs to promote our overseas clinical trials.
That is the business strategies and financial plan. Thank you. Dr. Zhou and the doctors has a sharing. Fantastic. Next, Zhou Wen. Zhou, are you there? Can you hear me?
Yeah.
We can hear you. Okay, thank you. Dr. Tang, Mr. Cai, Dr. Zhou, and Madam Hu, good morning. Just now there is a question about LBL-024. I would like to ask a question about LBL-034. Just now, the company shows the clinical studies about LBL-034. I would like to ask that for the phase II clinical trials and about the later stage of registration clinical trials. Just now, Mr. Cai shows about the potential roadmap. How about the future? What is the priority for that? Another aspect about LBL-034 is a bispecific antibody. We also notice that there is a trispecific antibody which is releasing some positive for encouraging data. Compared with the other products, what are our advantages and positioning for LBL-034 in multiple myeloma?
Another question, we see Johnson & Johnson, their mono plus their antibody to maximize the final results, and then to look some mono plus the TCE, which gave us some inspirations for the future, how to realize and maximize the commercial value for LBL-034. That is my question. Thank you. For LBL-034, when people ask about it, people always get concerned about that since the other competitors or the other products already get listed. How is Leads Biolabs going to work on it? As we focus on the patient's care, we would like to bring the extra value to meet unmet needs. Two aspects. First, whether it is more effective. Second, whether it is safer. Concerning about the two priorities, definitely we got very good results.
Even though we did not have a head to head compare with TALVEY, but we definitely got very high objective response rate, ORR, and the CR rate, complete response rate. Regarding for TALVEY, for the safety issues concerning about the issues, for example, like, anti-drug resistance or TCE disorders or the skin disorders, we are relatively lower for this type of complications. Another aspect for the patients who already go through the BCMA and GPRC5D, et cetera, or the other trispecific antibodies, because it is easy to cause some severe infections. It happens rarely in number cases. Another point is, last year, we see the PFS benefit. We have a 12-month PFS rate. Imagine about that 400 milligram to 1,200, and October 20th, we got a cutoff date until now. For the 400 and 1,200 milligram per kilograms, we did not reach the median PFS yet, like after six months.
You could imagine that for so long period time benefits, which is much better than TALVEY. Therefore, we are confident enough that for the development of further RRMM, relapsed/refractory multiple myeloma, definitely we are going to take the PFS as a primary endpoint. To check about the next stage of plan, focus on development as a registration clinical trials as a standard of care. These efficacy is definitely higher than the current standard treatment. This is a development path. For the second line, we will explore the other options, for example, PCL or the BCMA failed or treated patients. These are unmet needs for unresolved clinical issues. So we will focus on these indications and to see next step plan based on their toxicity results. For the PCL, it is under rare diseases. It could be a single arm first to market approval registration.
For other indications, it depends on the situation. Thank you. How about the analyst from Guolian? I am Guohong Yang from Guolian Minsheng Securities. We would like to know about the company's future development plan and progress for the ADC platform. For the ADC platform R&D, I could give you a brief. We are going to follow our consistent strategies and focus on the unmet needs. For the ADC platform, which is a buzzword, there is some misunderstanding about that. First is that the severe homogeneity, same target, and the same solutions. There will be the resistant issues. First, we need to solve the resistant issues. Therefore, we developed different toxins to solve it. Another one is dual payload to solve the ADC issues, ADC resistant issues. For the linkers, we also work on the next generation linker. It could realize the extracellular release, endocytosis.
The two effects are more like super rare work together for the current ADC, and will be even further improved. Another is the ADC plus TCE, and definitely going to solve all these issues like for drug resistance. These are the several aspects. We got several products that will be submissions for the R&D this year or next year. I think it is very unique. It will solve problems that it cannot be solved. That is all. Thank you. Thank you for your answer. Welcome. Next, we will invite Matthew from CLSA. Thank you. I got two questions. We talked about LBL-024, LBL-034, about the future BD opportunities and the potential collaboration, communication, and the update about the regulatory perspective. Second, LBL-024, it will be submitted BLA late this year. How about the commercialization perspective? Are there any updates?
Another point for LBL-024, you also focus on the combination with the chemo, as a first line for the SCLC and NSCLC. We would like to check about the safety level for the clinical perspective. I will share BD part and Dr. Hai share about the clinical part. We are working on the BD part. It depends on the deal party, our willingness, whether we are willing to reach agreement for LBL-024 BD, two aspects, for our working partners. First is about the safety issue. Historically speaking, there are some concerns. Right now, we got more than 600 joined patients in these trials. We talk about the safety issues. Another is a broad-spectrum activities. People worry that maybe it is effective for EP-NEC, but not for the other types of cancers.
This year we are going to show all this data, not just for the EP-NEC, to make sure it is a more broad-spectrum result. For LBL-034, it is a bispecific antibody. For trispecific antibody, it is kind of competitive, but definitely we got our advantages. For LBL-034, its efficacy is similar as CAR-T and is pretty safe. For PFS, we did not have the mature result yet, but definitely it will be good enough to make sure we are confident about that. We call it the LBL-076 and CD3 and GPRC5D and CD3. We believe it is also very good portfolio products work together with LBL-034. No matter whether LBL-034 or LBL-076, it could work together and combine very well. So very good pipeline. Then there is commercialization. We will make a decision soon. Make sure it is a right weighted structure and deployment.
We will consider in a careful way to try to find effective way to start the commercialization progress. No final confirm yet. For LBL-024 combined with the chemo safety result, the main safety issue is related with chemotherapy-induced blood-related issues. There is no safety issue found that has been identified yet. Roughly speaking, for the SCLC and NSCLC for the LBL-024 combined with the chemo, the result is similar as a PD-1 plus a chemo. The safety is very good. Okay, next. Alyssa from China Post Securities. Thank you for all your disclosure and sharing. My question is, why was 4-1BB target selected? We would like to update it to the bispecific antibodies. It is because the mechanisms, they got potential advantages. Second question is, how do you position 4-1BB in the future for our IO 2.0 competitive landscape? Thank you. I could give you a simple answer.
4-1BB is a very valuable target based on scientific natures. It is a second messenger of signals. In the CAR-T, we already shown this efficacy result. After adding into the R&D, it shows the expansions of proliferations and the activities for the clinical settings. So it is highly consistent with these biological activities. But before, we didn't make the best use of the CAR-T, which triggers could be in the labor. So that is a non-specific activation. But we try to use a specific or conditional activation, so that the 4-1BB could only be activated in the expanding T-cells. Another one is a PD-1 antibody. It could restore the functions of T-cells, but it can't expand the numbers of the T-cells. Therefore, 4-1BB actually could realizing the increases the T-cells achieving the differentiations combined with the other bispecific antibodies and PD-L1 plus VEGF. It has a tumor-promoting effect.
We know the VEGF will be increases significantly and come to a certain extent, and exceeding the ability of antibodies to neutralize it. So there are some similarities. After being activated, there will be lots of like experiments already confirm a separation, one, two, and PD-L1. Thank you. We see Guosheng Securities. Xia Jialiang. I am happy to be here to have this opportunity to ask a question. I would like to ask, what is the company's layout in the autoimmune disease area? What is subsequent data readouts rhythms for the LBL-047? Are there any important milestones this year? I would like to share about the important strategy and prefers that you could read out the data. Autoimmune, one is in the getting, one is activation, based on our platform data. Autoimmune will develop very well.
Right now, we didn't disclose our pipeline yet, but we hope next year, at a certain or right time, we will disclose it. Right now, it is so competitive. Our combinations is go to differentiated advantages. We also call the new targets. Therefore, we could explore more about the applications for autoimmune. So this is a general strategy, and we believe that definitely we are going to have a great results achievement for autoimmune sector. For LBL-047, it goes very well. After IND approved, end of last year, we started clinical trial. There are two aspects. One, you have the healthy volunteer, another part is SLE. For healthy volunteer, we already completed 3 dosage trial. For PK/PD result is very good. Safety result is nice. Then we are going to come to the fourth dosage validation, and then we will transfer to SLE human body trial.
We are going to start our first patient enrollment. When the data will be read out or have a public release, we will coordinate with our partners, Aditum, in the international report way. It will be divided into two parts. First part will be initial, like trial results, especially PK/PD, whether there is any KB dose, et cetera. For the other part of the data, we will still negotiate with our partners to finalize it. That is a general situation about that. Thank you. Next is Elisa from Huafu. Can you hear me? Thank you. I am Yang Fengyu from Huafu Securities. My question is related with the TCE platform. No matter whether for the autoimmune or for the other perspective, where we have very advanced pipelines, we are considering that we are going to expand it to the TCE platforms.
We would like to check about what are the key pipeline assets and clinical development plans for the TCE platform in the solid tumor program. For where, what is the milestone? What is the key target? Thank you. Thank you. For TCE, definitely there is a great potential. We really focus on this platform. If I put in a simple way, for the solid tumors or the hematological tumors, definitely it will great efficacies. Efficacies are actually different. For the solid tumor, there are not many T-cells. But for the hematological, there are so many T-cells. For TCE platform combined with the ADC, the combination result is not that good as a combination with the PD-1. We are also thinking about that. The core part is related with the T cell, the antibody going, but there are not enough numbers of T cells.
Therefore, similarly as the 24, we will expand the T cells in the large numbers. Therefore, the TCE will shown its efficacies for the solid tumors. Therefore, later on, for the TCE platform is not just related with the T cell. We will try to realize T cell expansions and proliferations. That will be the products launch next year. The TCE application in solid tumors. Another aspect is ADC plus TCE is a complementary combinations. The ADC kills the tumors, resulting in large numbers of T cell being cleared, at the same time enhances the efficacy. It is a very good combination. Thank you. Thanks for your answers, and looking forward to this first TCE platform published. That is all. Next, let us welcome Huatai Securities. Thank you for the opportunity. I am Li Hong from Huatai Securities. I would like to ask about the pipeline issues.
We see the company at the end of this year and beginning of next year, there will be new R&D submissions, early stage of clinical trials. We already see rich pipeline reserve. For the executive level officers, what is the priorities for all these early pipeline assets? Second is, we are developing about a bispecific antibody 66 for the other platform. We also see you are having the bispecific antibody, and we are wondering that what is the process? Will company continue to develop the new molecular or combination therapies based on the 4-1BB platform? Which are the main directions? What is the potential next generation molecule? For example, PD-L1 ADC. Next generation IO, et cetera, or the 24, this type of up-gradation, or you are more focused on the realizing better efficacy or realizing the whole molecular optimization up-rotation.
This is an important question. Generally speaking, from a strategy perspective, I would like to share with you, we are focused on the pipeline expansions and platform. But the main purpose is to try to solve the unmet needs, meet the unmet needs. We see the ADC, there is a drug resistance. IO already come to a bottleneck development. TCE cannot solve the solid tumor issues, except for the DI part. Another perspective, we will need to find the breakthrough points, and 24 could be improved plus the other mechanisms. Another aspect is the TCE is combined with the 24, could be a perfect combo. Second, for ADC, definitely need to make a difference. 061 plus EGFR and PD-1, which could solve the issues that the other bispecific antibody cannot be solved. The third is about the TCE application in the solid tumor could work.
We hope next year, we could have cases, have this application. TCE could also be used in solid tumor. So that is the main directions that we focus on. The main direction is solving or working on those problems that have not been solved or the needs that have not been met. So another perspective, we need to enhance all this platform. So that is it. Thank you. Next is from Guangfa Securities. Thank you for giving me this opportunity to ask the question. I am Long Zhengfang from Guangfa. Two questions. We have got the TCE ADC. What is the underlying rationale for developing TCE ADC? And the second question says, we got the AACR, published about the clinical datas, whether we could see any early, what type of indicators that we focus on. So these are good two questions.
Also, the questions that we are concerned about, and which also provide a very good opportunity for us so that we could elaborate on it. There should be kind of conditional activations for bispecific antibody. There are some antibodies cannot do the TCE ADC, because combined with the T cells, there will be killing of the T cells in the blood. In the tumor, there is a conditional activation, which is avoid the non-specific kill of the T cells. Second, from the specific of the molecular structures, affinity levels of TCE is much lower than that of TCE. And the affinities on both sides are symmetric, which leads to the different endocytosis. And the two molecular have very different endocytosis behavior, so it leads to T cell killing. Another aspect, how many molecules are on the surface of the cells?
More than 90% of the molecules at the surface of the cells and less than 5% of the molecule enter the cell. We hope that we could use the TCE to kill the surface. Like cell, right now, our human body experiment is similar, conforms to the animal results. Right now, we see that the efficacy of effectiveness or efficacy is very promising, and we are confident about that. We think the science will be reflecting the clinical results. For AACR, we focus on the TCE logic. Our poster will provide the relevant experiment to verify that. Thank you. Okay, so that is all for my part. And we are going to continue to invite the analysts from Western Securities. Thank you. I am Yan Ping Xiao from Western Securities. I want to ask about the commercialization strategy for LBL-024.
What are the main focus for the MNCs for potential collaborations on LBL-024 and other pipeline assets? Commercializing strategy already mentioned just now, I could re-elaborate it, three strategies. First, self-owned team, the second is CSMO, the third one, work together with the MNCs. We will have the best strategy to promote all our assets to commercialization. BD side also mentioned that we focus on LBL-024's efficacy. No worries about that. Second is a broad spectrum coverage of that cancer. We will show in the LBL-024 its efficacy for the other types of application. Next, from China Merchants Securities. Good morning, dear officers and the leaders. I want to ask that, as is already mentioned about the cash reserve and cash run out, I want to ask about the planned R&D and operating expenditures for the next three years.
Are there any refinancing plans in 2026? What are the expected milestone payments and the collaboration revenue for 2025 and 2026? Thank you. Thank you for your question. It's a very good question. From the 2025 annual briefing, we have already started a benign financial briefing operation, a sound financial operation. We're continuously generating revenues, which were CNY 170 million in 2025, and from a current pipeline, there will be an increase, at least a 50% increase, in 2026. There will be significant increase. We will continue to do the focus on building the future. It's a virtuous cycle, so increase R&D. I believe that with sufficient funds, we will continue increase the several blockbuster products for the preclinical development, like LBL-024 and LBL-034. We're going to enter IND application stages, which support the whole cycle of IO.
We also see reflect on a light assets business models, which are going to be very efficient, focused on R&D. We get the best use of a technical platform that invest for 10 years. Definitely, the cost results will be higher later on. For the cost perspective and the enrollment of the patient perspective, we have fully in-house, self-built clinical team. Therefore, you see the whole business model perspective and financial arrangement will be super efficient and entering the virtuous cycles. We're really looking forward for the final results. Refinancing, we still got CNY 1.55 billion, which is kind of sufficient. Last year, we also got CNY 200 million last year. The overall possibility, 200, yeah, we're looking forward for the, or be open about that.
Thanks for all the detailed answers brought by our management levels. Today, the time is limited. There are still questions from online, offline. We can't cover all of it. After the conference, you could contact with our team or our moderator or securities. In the end, I would like to invite Dr. Kang to give us a briefing or summary. The floor is yours. Okay. Thank you, Dr. Lei. I would like to show my appreciation, and welcome to all of you to departing to our conference. As time is limited, I could answer all the questions, but lots of good results achieved after hearing all your voices and questions. Looking forward to 2026, which is a key year, and our BLA will be submitted. Also, the data for the other indications will be shared. Until now, there will be four cases. There will be four R&D.
We're going to show the four R&D data and the results, which are pretty high quality. If you are interested, you could chat more about this part. We got the LBL-024 and LBL-034 approved products. We also got the two bispecific antibody ADC and TCE, et cetera. We're really looking forward that you could come up with your questions. We are happy to answer all of it. Hope all of you could continuously follow us and support us so that we could work together to build the company to a stronger and better company. Thank you. Thank you, Dr. Kang. We're looking forward for the full results, and thanks for all the participants and investors, and we hope you will continue to pay more attention to us. That's all for us for this conference. Thank you. Thank you for all your participation. That's all for this meeting.
Have a nice day. Bye.