Thank you, investors, for taking the time to the Kelun-Biotech 2026 interim results presentation. Today, I'm going to talk about four parts.

I will start with the business overview. I will be taking over the overview, followed by the China's commercialization, which will be presented by Mr.

Ding Nanchao, and then clinical development progress and strategy, which will be presented by Dr. [Xue Xiaoping?]

, and finally CFO will present financial and business performance. Let me briefly go through the business progress.

I think you know this slide very well. Kelun-Biotech is a company that's dedicated to oncology, anabolisms, as well as other therapeutic disease.

The controlling shareholder is Kelun. Second largest and main partner is MSD.

From the profile, you can see we have 30 pipeline assets, including 4 products with 8 indications approved for launch. We have 3 NDA submissions, which is in the process involving 2 products.

We have 10-plus pipeline projects in the clinical stage. As of the 30th of June, Kelun-Biotech, we employ 2,300, including 900 R&D, as well as 550 production and quality management, and also the new commercialization team is now over 800.

I will take a moment to talk about the business strategy of the company. Firstly, we have established a complete system from R&D, development, production, to commercialization.

In terms of R&D stage, we have three major platforms. If you know us, you know the ADC, which is the drug conjugate platform.

We have antibody, monoclonal antibody, bispecific, and large molecule and small molecule R&D platforms. Over the years, as with the use of AI, particularly in development of innovative drugs, AI is being widely used, increasingly more common.

Over the time, Kelun-Biotech has been integrated AI in our R&D process, enhanced efficiency of research. In production segment, we have the complete system from antibody, small molecule, to conjugate, and formulation.

We have a complete suite of manufacturing capability. At the same time, the quality system, in a half year in the past, has been inspected multiple times by the National Medical Products Administration, QP certification from the European Union, as well as our international partner who conducted on-site audits.

They have all endorsed our quality system. Of course, importantly, this is about commercialization.

This is our first commercializing, the year for commercialization. Multiple product has been covered by medical reimbursement.

This is in line with our expectation. Later on, Mr.

Ding Nanchao will talk more about commercialization. Secondly, I'm going to talk about international collaboration.

Whether it's the large molecules, small molecule, or ADC projects, have been working with multiple MNCs with BDs. Of course, most importantly, the partner is MSD, where we have multiple ADC product being developed in collaboration, like the sac-TMT, which is the TROP2 ADC.

We have 17 Phase 3 clinical studies ongoing. The very first project for EC, which is a Phase 3 clinical study, we have already announced a positive results, both positive results in PFS and OS.

Also MSD recently is going to file for listing approval from FDA. Other ADC is also ongoing in clinical collaboration.

In the past year, another progress was ADC with SKB105, which is where we license Crescent. Crescent is also conducting the global clinical study worldwide now.

Now, through the international collaboration, we are expanding and helping us to enhance our clinical study outside of China, as well as the overall registration, regulation communication, which has helped us to build our capability, and also accumulated experience for going global, which is build a foundation for our future globalization and global expansion. I'm going to spend three slides on the product pipeline strategy, starting with the oncology-related product pipelines, particularly the conjugate drug technology.

This in clinical stage, we have 315, 571, 400, 100, and we also have two approved project, which is sac-TMT, ADC, and also the trastuzumab botiditin, which has been approved for launch. Also in clinical stage, we also conducted the preclinical study, which includes the drug conjugate.

Those are in three groups. The first group is what we call the single-payload, new type of ADC, which include the RDC with the nucleic acid RDC, and also drugs that with the payload of immune agonist and payload, such as these drugs, and also you are also interested with the degrader, which is synthesized as a new cytotoxin payload.

Now the second group is what we call the dual-payload drug conjugates. Dual payloads include the cytotoxin plus cytokinin toxin, two toxins combined.

It could be a different type of toxin, and also dual payload with the immune agonist plus cytotoxin. You can see the 565, which is now in clinical stage, we're also developing the protein degrader plus toxin as dual payload, and DDR inhibitor plus toxin conjugate.

The third category is what we call tumor antigen targets with some immune or anti-angiogenic mechanism, such antibody and small molecule payload, with the polypeptide conjugate drugs are also under development. Now the second type in the second slide, this is in our pipeline strategy.

You can see clearly from monotherapy to combination. This is very important strategy from monotherapy to combined therapy, to later line to frontline.

This is a combined ADC with RO. This type of synergistic therapy based on different antitumor mechanisms, by combination, it can better overcome the tumor heterogeneity, and also hopefully will overcome the drug resistance.

This is really important in our development strategy. We developed ADC plus PD-L1, whether P81 combined with pembrolizumab.

We can see the first PD-L1 positive results has been read out in the Phase 3 clinical study, and NDA has been submitted. At the same time, for PD-L1 negative and non-small cell lung cancer in Phase 3, which also reached our main endpoint in the study.

This is for Ki-ras. Also we have other Phase 3 clinical trials working with our global partner, MSD.

They are conducting study on breast cancer, lung cancer, as well as the gynecological tumors, endometrial cancers, and also other ADC drugs like 315, 571. You can see 500, 500 has already entered Phase 2 clinical trial.

Now the second type is about combination therapy: PD-1 and PD-L1 combination, and also we also bring in PD-1 with PD-1 VEGF combination, which is called SKB118. More recently, for sac-TMT combination, we also have a Phase 2 clinical study, where we have just receive approval from the national authority from July, and now we are enrolling, recruiting into the study.

At the same time, in the future, we're going to combine explore new indication with combination therapies. For the 118, which is a bispecific, will also be combined with other ADC, and we explore the combination of those drugs.

Those are what we talk about combination therapy. As a combination therapeutic synergy, there is also important strategy, which is what we call integrated development: immunotherapy and ADC to be made into one molecule.

There are two way two directions. On the target side, we combine the target with the oncology with a immuno target, which you can see in KSKD103 project.

That was how we combine two targets, one on oncology, the other on immunology. Also the 565 project that we mentioned, which is a different mechanism.

One antibody with the conjugation with different toxins, with dual toxins. However, the toxin is also payload with immunoagitation.

This is also in the preclinical discussion. Also in the preclinical strategy, also as part of the integration strategy, which is also from the conjugate strategy.

Thirdly, the pipeline on the non-oncology projects. On the non-oncology projects, it's also in clinical study.

Representatively is the SKB378, which is now in Phase 2 and Phase 3 study. Our overseas equity has been licensed to the Vevo Bio.

That company is now conducting the Phase 2 study, global study on COPD, and they have completed the first group of patient enrollment. The first group of patient has been dosed, actually.

They have Phase 2/Phase 3 study for asthma. They also completed dose exploration.

SKB575, which is a dual-target non-oncology product, is actually for atopic dermatitis and asthma. The IND has been approved in China, is now conducting Phase 1 clinical study.

At the same time, for the conjugate technology, we are also exploring the drug conjugate in non-oncology indications with the non-cytotoxin payload, and also using the drug conjugation technology is now being developed. Soon it's going to move into clinical phase.

Those are the pipelines. Now briefly to talk about in the first half some of the achievement that we make.

The pipeline, and then commercialization and financing. For commercialization and financing, Mr.

Ding Nanchao and Mr. Zhou Zejian is going to report further.

I'm going to talk about clinical progress. Now first of all, in February, in the second line, ER-positive, HER2-negative breast cancer has been approved for launch in China.

At the same time, in NDA phase, the sac-TMT for first-line triple-negative breast cancer and the first-line PD-L1-positive small lung cell cancer were also reviewed for new indication. Of course, we also have a series of new Phase 3 clinical trial underway, with results for key endpoint already available, which include other clinical strategies, where Dr.

Wang Jingping will further present to you. In terms of commercialization, I want to present to you a important point that this year, this is early August 2026.

In terms of the national insurance negotiation, which is intensely underway, you can see the sac-TMT for three indications for sac-TMT, including what we have approved, which is A166. The trastuzumab botiditin, that has approved the medical insurance negotiation, form review, and also we are now involved in the reimbursement negotiation.

For other commercialization, I think Mr. Ding will comment further.

Now let me talk about in the first half 2026, in terms of academic publication. You can see, first of all, on ASCO, we have two oral presentations.

This is about registration clinical study with two oral presentations: sac-TMT for PD-L1-positive NSCLC. The other was on the 400, which is the rimonabant [lambatenib?]

registration study for the RET NSCLC. Also in ERCC, we also have a Phase 3 lung cancer study for EGFR-mutant lung cancer.

Also we have a range of Phase 2 clinical study to be reported on ASCO, academic journal like Cancer Cell or JCO. Of course, we also have publication simultaneously in The Lancet.

I'm going to briefly report to you Kelun-Biotech's overall strategy as a company and the future outlook. We'll continue to promote differentiated innovation to meet the unmet needs, and also innovation pipeline will be continued to innovated on the ADC platform, whether it's a new linker, new strategy, or the new cytotoxin, or the new conjugation technology in terms of the structure of the ADC.

Also, we're going to expand to the non-mainstream area, and also we'll continue to expand and consolidate our end-to-end development capability, particularly commercialization. The commercialization capability will be further enhanced.

Also, in terms of global strategic partnership, we will continue to optimize the system to build the company into a world's leading biopharmaceutical company. Now I'd like to have Mr.

Ding Nanchao to talk about commercialization.

Can you hear me clearly?

Yes, loud and clear.

Good evening. I'm going to talk about the first half 2026 in terms of the progress and commercialization.

You can see up to now, we have four products successfully commercialized and launched. Later this year or early next year, the first small molecule product, 400, will also be launched.

In the first half of a year, the overall product revenue reached 765 million yuan, with a year-on-year increase of 112%. If we were to look at the business growth, I can I think we can take two angles.

We should look at the excellent data and how the experts has been endorsing the high-quality clinical data, and and it grows from change of therapeutic philosophy. We have multiple globally leading high-quality clinical study which has been read out, and they have been published in important academic congress and journals, further enhancing the evidence, and also helping the product.

For example, for our clinical evidence has also expanded from EGFR-mutated NSCLC on the third line, and expanding to the driver gene-negative NSCLC in the first line. This also presenting the excellent competition competitive efficacy and clinical value for our product.

With the presentation of high-quality data, our innovative product also gained more endorsement from experts, and we have been included in multiple guidelines and expert consensus in the country. At the same time, we continue to engage high-quality medical education and academic exchanges, so that clinicians understand more about the product mechanism, efficacy, safety, and indication, continue to help to convert people's treatment philosophy, and further enhancing the confidence for physician to adopt the innovative therapy.

The most important products in the lung cancer, we have established ourselves as a standard in the second line and preferred product for the third line. TNBC, we also have the preferred brand for TROP2 ADC in triple-negative breast cancer.

With the high-quality evidence and expert endorsement, guidelines recommendation, and clinical practice, we are forming a virtuous cycle, continue to accelerate the value, and also providing benefit to the patient, and also build a foundation for commercialization ramp-up. Secondly, the growth perspective is really from the market access policy and the change of the access environment, with higher accessibility of the product.

The growth also from comes from higher accessibility. Now we have three products, commercialized product with five indication being covered by medical insurance.

You can see [Jiatilai?] , this is this is the a intrathecal monotherapy pam in the catalog, the only one used to treat TNBC and NSCLC as a domestic ADC.

With that kind of access policy, we greatly enhanced the accessibility to patients. We are also promoting the doctors' prescription motivation and the convenience for patients' medication.

This is really enhancing the experience. At the same time, other than indication, Mr.

Ge has mentioned, we have new two new indications: the second-line NSCLC, and also the, HER2-positive sorry, HR-positive/HER2-negative second line, and also the T-ADC, which has been reviewed to be commercialized next year. With the access policy, it's also making hospital hospital available to us.

In the first half of the year, we quickly got coverage for reimbursement. We have been able to to be listed into the hospital temporary procurement and dual channels.

We are entitled to multiple channels for medical reimbursement, the patient are finding our product more accessible, and they enjoy medical reimbursement. We cover multiple province in China.

We quickly convert the reimbursement value, and now we operate in 30 provinces, 300 cities, and 2,000 hospitals, where we have full coverage. Much work require a bigger team.

In the first half of 2026, we almost doubled the headcount of the commercialization team. Earlier on, we built our different supporting roles, medical marketing roles.

However, in terms of sales team, we doubled the headcount this year. Also, we are improving the capability build-up of different functional roles and functional departments, and we are we are able to cover more provinces in the second-tier regions.

As we cover more and more top hospitals, we are now covering more second secondary county-level hospitals, so that we are able to enhance our coverage in China. Also, we completed registration of medical reps to do it compliantly.

Now, thirdly, in the future, with the indication roll out and product promotion, I think in lung cancer, we look at the mutated patient to drive the penetration of ADC in mutant population. In the first half, we have we already achieved reimbursement to cover the third-line mutated patient.

Also, we focus on the benefit in PFS and OS. Also, we have the medical reimbursement, this is really achieving outstanding advantage as a monotherapy.

Now, going forward, we're going to go to second line in the mutated population, to expand into mutated population in the second line. Over longer term, I think sac-TMT is going to go for non-mutated population, particularly in the first line, which is a bigger population group.

I believe the launch of indication next year, this is going to this is going to be very important for us to for sac-TMT to become the dominant players in lung cancer, and also, also we can be a leader in breast cancer. We'll continue to drive the, adoption of ADC in the advanced TNBC and breast cancer overall.

We're going to focus on enhancing the role of ADC. We want to switch from traditional regimen to innovative regimen.

At the same time, sac-TMT is also going to be highlighting its differentiation with other categories in terms of target indication, and payload differences, and safety differences, so that we can highlight our clinical advantage, so that we can provide more option to patients. I think we already got reimbursement for second line, and next year we're going to drive the driver gene-negative driver gene-negative population, which is a greater population.

This will produce significant clinical benefits, and also we're going to gain market share. Of course, other than the blockbuster sac-TMT, in the first half, another product, which is the cetuximab, N01, we also make very good process progress in cetuximab.

Now, first of all, it has been covered by reimbursement catalog, and with the product, it's really the first one in the world to have completed a head-to-head, large-scale Phase 3 study to achieve the clinical efficacy verification. We also set a very competitive price, we can quickly capture market share.

In the first half, we have market coverage of 1,100 hospital in the country. Compared with the original drug, our cetuximab has a better value for money.

Compared with the domestic competition, we have better indication, we have more expanded indication to meet the needs. We can, with the reimbursement benefits, with more coverage of the hospital, this cetuximab N01 is going to achieve greater potential.

Particularly in the incidence of the colorectal cancer, in China CRC is high in terms of incidence. Also, with the standardisation treatment of the, biomarker testing from CRC, this will further enhance the genetic testing rate for CRC, and the EGFR category will be further expanded.

Thank you. Dr.

Jin, can I ask you to talk about the clinical progress?

Dear investors, good evening. I will just spend a few minutes to talk about the clinical progress year-to-date in 2026.

I will leave more time for Q&A. Overall speaking, now in terms of clinical progress can be divided into four areas.

If you look at the core product, sac-TMT has been moving from later line to frontline, and from the Chinese and also being promoted to the world. Also, the next-generation ADC, I will talk about 500, 571, and 400.

They are forming a new value curve. At the same time, the OptiDC platform is also moving from traditional ADC, which is a tradition ADC, to dual-antibody ADC, dual-payload ADC, and also ADC is also combined with the new RO 2.0, which is PD-L1 and VEGF.

In that regard, the non-oncology SKB575, we have achieved clinical study in Phase 1 on healthy subjects. Now in terms of dermatitis, asthma, we also conducted Phase 1, Phase 2 study on atopic dermatitis and asthma.

Now, when it come to sac-TMT, which is the core product, it's been mentioned in February it's been approved in the indication for breast cancer for HER2-positive HR-positive/HER2-negative. Also in the first half of the year, it's also approved for first-line it's also got a positive result in the first-line TNBC.

We have submitted the NDA. We got preferential review, and also presented in the ASCO this year.

Next slide. In this year's ASCO, we reported a heavyweight Phase 3 study for EGFR wild-type, PD-L1-positive patients.

You can see the hazard ratio was 0.35. Particularly for TPS above 50%, PD-L1 high expression, the hazard ratio was 0.47.

Whether it's a PD-1 1% to 49% or PD-L1 high expression, we have achieved excellent PFS benefit. Of course, we have seen excellent trend of benefit in OS.

The OS reached 0.55. In July this year, we have announced that in another large Phase 3 study, which is for EGFR driver gene-negative, PD-L1-negative NSCLC, we have achieved excellent positive result, PFS positive, and OS also show a trend of benefit.

We plan to report the Phase 3 result on ESMO this year. The sac-TMT, whether it's a PD-L1-negative or PD-L1-positive patient, we cover them all.

This goes to prove ADC, TROP2 ADC, sac-TMT, can become a backbone therapy to replace chemotherapy, and also combined with immunotherapy. On this slide, I'd like to the last slide.

I'd like to just emphasize that going forward, most importantly on the sac-TMT with the flexible RO 2.0, V2 V1, V2, V3 development, in the lung cancer, we have started Phase 3 study. We already have patient enrolled.

Subsequently, we're going to explore on other solid tumors with the sac-TMT. Also, we want to combine sac-TMT with immunotherapy with the PD-L1.

Also, hope our Phase 2 Phase 2 study can be shared with MSD, MSD could conduct more sac-TMT combined with PD-1 and VEGF, like the 264 combined with PD-1 to replicate that success. I'd like to emphasize, as mentioned, in Europe, the Lung Cancer Congress, we have reported the OS results, the sac-TMT on the third-line population who fail TKI and fail the dual anti-VEGF treatment.

The mean OS, we have achieved 20 months of mean OS, and hazard ratio, considering the crossover, the hazard ratio of sac-TMT was 0.45, which is very good survival benefit on the OS, which also proves sac-TMT provide long-term survival benefit. Finally, let me talk about 400.

400 was actually presented by Professor Wu Yilong on WCLC meeting. We look forward to be a second-generation or next-generation RET inhibitor in terms of safety, efficacy.

This generation of RET inhibitor has demonstrated excellent efficacy, the PFS. In the later-line population, the mean PFS was 27.5 months.

In the first line, untreated first line, PFS will be over 30 months, which is a very nice, efficacious results. Safety is also very good.

We look forward to what Mr. Ding was talking about, the commercialization of 400 as a product.

Finally, just a summary of the clinical progress. We have make a lot of progress in clinical studies.

The sac-TMT has been now used in the first line. MSD has got a positive result in a global study.

Now going forward, the 500 400, 500, 571, they also got pretty good results in Phase 2 study. Please stay tuned in the ESMO, where we're going to present the results of 106, and MSD will report the 05 and 03 results as large Phase 3 clinical studies in the second half of the year.

With that, thank you.

Thank you, Dr. Jin.

Finally, just a few minutes on the financial performance of the first year, for the first half of the year. Firstly, revenue, profit.

In the first half, the overall revenue was 978 million RMB. The compared with last year, it was kind of stable versus last year, but there's a big change in the revenue mix.

The commercialization revenue in the first half contributed 657 million, which is over 100% compared with last year. You can see, as the commercialization activity are getting deeper and deeper, we can expect the commercialization revenue to make even greater contribution to the overall revenue.

Now, GP margin was 7.36% sorry, 736 million gross margin. We achieved profit in the first half of 388 million.

The profit was benefiting from the settlement-related collection of the first half of year. If we exclude some of the nonrecurring, income incentive operation, the adjusted profit should be 476 479 million RMB.

Regarding cost, expenses, now the cost the cost of operation was 241 million in the first half. In terms of amount, it was down by 10.

16.9% year-on-year. The COGS COGS was actually higher accordingly.

This has to do with the higher drug sales in the in the year, and also also other R&D-related costs, which is part of the cost, including employee costs and really experimental trial expenses, those has been decreasing. This is actually consistent with the trend of overall, collaborative income.

In terms of R&D expenses, 768 million RMB, increased by 25.7% year-on-year. Dr.

Jin mentioned this year, we have more clinical studies this year, R&D expenses has been slightly higher. Now, administrative expenses was stable: 79 million yuan.

The, sales and distribution expenses, 390 million. Compared with the same period last year, there's a there's an increase, which is consistent with the higher commercialization revenue.

Finally, about the asset liability, as of June 30th of the year, the total assets was 3. 6.322 billion RMB.

Compared with last year, it was increased by 5.56%. The main composition of assets were the cash and financial assets.

Cash and financial assets total 4.783 billion yuan. Liability at June the 30th, it was 985 million.

Compared with last year, same period last year, it was decreased by 12.18%. The asset liability ratio is around 15%, which is very healthy.

With that, that's the financial performance. Now we're going to take questions.

As you can see, we have a lot of analysts who come a long way, and also we have online audience. You are also welcome to ask questions from the online channel.

Let's start with taking question in the in the room. Maybe lady first.

Thank you.

Thank you, management. Indeed, we are very impressed by the data, particularly the the disclosed data from 264.

It was really amazing data. You can see like 264 in all the lung cancer clinical studies, in China or outside China, all the clinical trial has got excellent results.

As I understand, like 264, including 264, there are quite a lot, TROP2 ADC, they have conducted the first-line combination with the pembrolizumab in the first line. They all achieve good results combined with pembrolizumab.

My question is, well, comparing 264, actually started the Phase 3 study in 2024. You are making good progress because you you have already enrolled for a year.

You have a lot of data build up already. I'm curious that in the global multicenter, EGFR-mutated first line was not initiated yet.

My question is, for this indication, this is a big, indication. Tagrisso already has about $6 billion or $8 billion sales because FLAURA2 compared with the Tagrisso, which is osimertinib, they also have much longer mean PFS.

Normally, combining ADC with Tagrisso is supposed to have a higher sales dollar amount. It's it's going to be a very big win.

We haven't seen the global initiation of that indication. I was wondering, do you have a better choice?

Also, is that potential opportunity of 571? If that's the case, what's the advantage of 571 in that indication?

Also, if you were to conduct clinical study, would you compare with FLAURA2 as a head-to-head?

Thank you. First question, first of all about the global Phase 3 EGFR-mutated first line, you're asking about the consideration, and 571, the prospect, 571.

Maybe Dr. Jin, can you take that one?

That's an excellent question. Indeed, in China, we actually have a social study that has been quite early.

The last patient enrolled was in last September last July. Up to now, we have been treating patient for over a year now.

We are looking forward to it, because the data is so good. Phase 4 data is kind of slower than what we have thought, probably we won't be reading the Phase 4 data out until Q1 next year.

When it come to MSD's global development, there are things that we are not in the position to make disclosure. On the one hand, the Phase 3 clinical data, can it be used for application in another country or other region?

We're trying to explore that. Secondly, 47 571, indeed, 571 is another important collaboration with MSD after the 264.

We have not been disclosing the target. However, it is actually having a very good advantage among the populations.

We'll consider developing the molecule 571 combined in the second phase. In the future globally, are we going to do head-to-head with FLAURA2 in the Phase 3?

For the control group, because Mariposa has been approved in US, at least the control group need to include the Mariposa as a regimen, those could be part of consideration.

Thank you. I have another question regarding the PD-1/VEGF strategy.

Now, with MSD, you both have a PD-1/VEGF, and in the interim result last time, it was mentioned by Mr. Ding that PD-1/VEGF, they will be using their PD-1 PD-L1/VEGF is already on the agenda, and you, Kelun-Biotech, you have your own PD-1/VEGF.

In your presentation, you also mentioned the combination therapy used on non-small cell lung cancer. My question is, in terms ADC and PD-L1/VEGF combination, are you going to plan separately, one in China, the other differently for overseas?

If that's the case, for your ADC combination indication, what would be indication other than small cell lung cancer? What are the indications, and what are priorities?

Thank you.

When it come to development in China and overseas, actually we have the PD-L1 from Crescent, the right in China. We do have the right to develop the combination in China, and also in the ASCO and other investor meeting, because they already bought a BGB's PD-L1 at the time, they have the right to develop.

I think both sides have the right to make their own independent developments, and respectively, we also have strategy setting for our own development. On both sides, we have been maintaining a very nice communication pathways and channels.

We will consider at the right timing, or the right time, to see if there could be any synergy. Now when it come to the PD-1/VEGF development strategy, again, Dr.

Jin, can you talk about PD-1/VEGF development?

It was mentioned, if you've been following the announcements or the MSD's announcement, the two PD-1/VEGF, they have the tetravalent structure. Like PD-1/VEGF as a backbone, those are very similar.

It's mentioned that MSD is developing PD-1/VEGF. They have done a lot.

Like in the past, lenvatinib and many other experience already achieved, including lenvatinib. Also, the sac-TMT is covering a broad range of tumors.

We are thinking sac-TMT with PD PD-1/VEGF, first of all is on the non-small cell lung cancer, because the TROP2 ADC combined with pembrolizumab being successful. We are looking forward to TROP2 ADC, sac-TMT, to have a flexible application of PD-L1 on non-small cell lung cancer.

We also consider other tumor like breast cancer, because sac-TMC address multiple tumors, a broad range of tumors. They have nice antitumor activities.

As mentioned, we are actively exploring and sharing our second-phase PoC data in China with MSD. Also, hopefully we'll support MSD to have a sac-TMT/PD-1 combination therapy in the world.

Previously, MSD has launched 17 sac-TMT Phase 3 study, and many Phase 3 are in combination with sac-TMT combined with their own pembrolizumab, PD-L1. In the future, we're looking forward to MSD to use sac-TMT to combine with PD-1/VEGF in multiple tumors in global Phase 3 studies.

Thank you for having me. I'd like to ask further follow-up.

You have the 11A, which you have obtained the China right for 11A. What is your strategy consideration for getting the China right for 11A?

Understanding, of course, they have a very nice clinical significance in the Phase 2, which help us understand the clinical benefit of ADC plus PD-1 or PD-L1. What's the plans to advance product for to achieve China registration?

The second question is what has just mentioned, you have talking about putting immunotherapy and ADC together and putting them into the same molecule. I'd like to ask, in the case of ADC plus PD-1 or PD-L1, which is a more direct combination therapy, what kind of differentiation want to see by making them into the same molecule?

Right.

The first question about positioning strategy for 11A, I think Mr. Ge, can you take that?

I think this is a very nice question. We have been talking about like PD-1/VEGF.

These are three different antitumor mechanism vis-a-vis ADC. One is the cell killing, the other is immunity, and also VEGF is about anti-angiogenesis.

Looking for combining the three mechanisms in combination, they can play the respective role as in synergy. We are still exploring.

Right now, we are exploring. It's not just about efficacy.

More importantly, we want to see the safety in the combination. Would the safety be supportive of a longer-term benefit from that product?

That's the most important thing that we're looking at now. Secondly, for us, the OptiDC, which is the ADC platform, this is our backbone, including different drug conjugate, which is the backbone of the company.

Regardless of different combination of immunotherapy combined with monoclonal antibody or combination with PD-L1 or VEGF or combination with TKI, it's all around the drug conjugate. It's a combination with our own drug conjugate based on the conjugation technology.

Back to 11A, it's going to be a nice partner with ADC with different ADC, different tumor. We are evaluating the antitumor activity, and based on the tumor microenvironments and different feature of the tumor.

We're going to explore those features. Where are we going to go for clinical registration?

For monotherapy, we don't have plan for clinical registration of 11A as a monotherapy. At least now, we think of it as a combination partner ADC.

At least this is how it's been envisioned as a combination together with ADC. The second is about ADC IO integration design.

Talk about our integration, including payload integration with two mechanisms, and also the antibody integration. Dr.

Yu, Dr. Tan is here, we have the synergy of the payload and the synergy of the antibody.

Can you talk about that?

Let me respond to that. The dual payload, like 565, is one with traditional cytotoxin with immunostimulatory component.

This is a mechanism compared with the ADC plus IO, it is somewhat different with ADC plus IO. If you make it into one single molecule, the benefit is or the differentiation is that it has a fixed ratio that can make entry into tumor cells.

You can regulate how much of toxin, how much immunomolecule get into the tumor cell to play the best effect. Now, the second point, ADC, now, once ADC goes in, there are so many tumor cells.

You are not able to ensure that they are getting to the same cell. However, if we can make into one single molecule, then the two payload can get into the tumor cell together at the same time.

Potentially in theory, we're going to have better tumor killing, and also other benefits. Like if you have one single molecule combining two, then for patients, it might be a benefit economically.

Particularly overseas, of course they want to solve the problem with one drug rather than two. All our products are not just thinking about China, but also international market.

We have to think about all different considerations. Let me

let me add to it. You probably have seen like the HARMONi-6, the updated data from HARMONi-6, PD-1/VEGF plus chemo.

PFS was was actually 0.72, which is updated data, which means PD-1 plus chemo, I mean it could be better than PD-1 PD-1 plus chemo. However, it has not achieved a very good, ideal therapeutic results.

I think PD-1, PD-L1 plus ADC plus the sac-TMT, and then the immunoagonist could be anchor the TTA onto one molecule. Maybe we're able to turn a cold tumor into hot tumor, so that the immunity effect can be better enhanced.

At the same time, we're thinking about the KB103, like SKB103 molecule, can we put on top PD-L1 and VEGF? The immune agitation can achieve better potency of immunity agitation.

In the first line in non- a small lung small cell lung cancer, and many cold tumor, they can actually add on the immunity effect, so that the benefit can be more enduring. The ultimate goal is about survival.

It's not just about ORR. We want to achieve OS benefit.

That's the design we're thinking, designing different things to one molecule with PD-1, VEGF, and RO, maybe we can achieve better OS benefit. That's the ultimate goal.

If you look at the ADC journey, you can see at the very beginning, we look at ADC and bispecific, bi-payload ADC, and then you can see ADC combined with PD-1 combination. You can see the results of how ADC combined with PD-1, we have better better benefits.

In the journey, we're trying to put the advantage of ADC and advantage of IO into one molecule. We're combining ADC and IO target into one molecule.

So 21103 as a project, you can see we have not stopped the progress in the exploration. In ADC, we constantly pursuing a better antitumor effect and the longer interval before drug resistance arise, and and and also we are having better and better immunotherapy, better IOs, like ADC combined with VEGF.

We have very nice effects, very nice results in PD PD-1/VEGF. I think and also our 1 118, the results of our own 118 was also very good.

I think the combination with IO, the bispecific IO, it's not just about ADC, sorry, it's not just about PD-1 and VEGF, actually we'll continue to explore the process.

I think that's a very good question. Right now, we are not able to answer it completely: what's the ultimate clinical value?

Should it be in combination therapy, or should we should we make them into one molecule? We say it could be a better safety, better efficacy.

However, I think this is still a open topic. This question is still open.

Everybody can see the simple combination. If you just put two drugs in combination, the benefit is you can adjust the dosage more flexibly.

However, for two molecule, I can adjust any single molecule the dosage, it has advantage. Because in one molecule, we have different development strategy.

I didn't elaborate today. If you were to make it into one single molecule, what's the advantage over a combination therapy?

This is really set by our TTP. You can promote is endocytosis, it can promote release in tumor microenvironment, and in the translational research, whether it's a pharmacodynamics or pharmacological research, we can expect a synergy effect.

This is where we are developing into optimized integrated molecule. We we do have our TTP.

We're not able to elaborate, but you have to think about the factor before integration.

There's a question about sales. We talked a lot about the first half of the year, the sales figure has been very nice.

You talked about you have medical reimbursement covering the two second-line indications, and also going to be a non-mutant first-line indication to be declared and approved. I'd like to talk about the medical insurance negotiation, some prospective information, anything you can share with us, and the sales outlook for the next year.

Let me respond to the second question. Right now, we're at the stage of making estimates.

Whether 264 with the new additional indication or the 166, if they were to be enrolled into the Chinese review, now if you understand, this year the national negotiation has the lowest pass rate in history. Last year, we had 40% success, but this year it was only 34% success to pass the review.

Right now, we're talking to the authority. We're talking with the experts.

I'm not saying we have a price advantage, but we are actually progressing toward our goals. I expect next month, it will be approved, because this year the speed has been very fast.

Perhaps the negotiation could be done by September already. You talk about commercialization outlook.

We can expect further headcount increase, that's for sure, because next year we have two more indications to be covered by medical insurance for the second-line EGFR-mutant population. Definitely for that indication, this population will achieve greater results.

For the HR-positive/HER2-negative indication, definitely this is a much bigger population compared with the current TNBC. We are very confident in the market growth next year.

In terms of commercialization, next year we're not just having 264, we're also going to have 166 to be covered by reimbursement. We continue to build up our breast cancer team.

We have break it apart as a separate team. We're going to increase the headcount.

Thank you for having me. A quick question: you have three commercialized product, you have disclosed revenue for the first half of the year.

Can you break it down by product, like 264 and the revenue from non-264? Second question is a follow-up on the commercialization, because the OptiTROP-05 combined with pembrolizumab, this has been submitted for application for launch.

We can expect the approval, commercialization, and reimbursement coverage. My question: how would you work with the pembrolizumab to collaborate with pembrolizumab for the national negotiation and access?

What information can you share with us? Now,

first of all, in terms of disclosure, I think Mr. Ding can

talk about the sales disclosure. We talk about some key products, including the sales positioning of the different products.

Of course most revenue come from sac-TMT, 80% from 264, 80% come from sac-TMT 264.

The second question, Mr. Wei?

Yeah.

Based on the disclosed data in treatment, particularly the wild-type lung cancer, our data is very impressive. In the future, we're going to be practice-changing.

If you just look at the data, this is a indication has huge clinical value. Secondly, in combination with pembrolizumab, we are working on the medical reimbursement for the indication.

We talk to the regulator, industrial association, and universities. We're trying to shape the policy.

We're trying to change the policy. As pembrolizumab is not covered by reimbursement.

Secondly, we're also talking with MSD. Next year, maybe it's possible for both of us to be covered by reimbursement.

It's still some time before we got approval, but we still have a lot to do, but we have started it from the end of last year.

Linda?

Thank you for having me. I have two questions.

You have clinical progress for new type of ADC other than 264. You also have like 112, 32.

You are making clinical studies both home and abroad. I'd like to ask about ADC 2.0, the next-generation ADC.

Do you have any advantageous pipeline where you're going to prioritize clinical Phase 3? I want to ask about the sequence for your later pipelines, any key indications.

I want to learn about the key indications, if possible. Also, you reach a settlement with Yilian, and you received 700 million RMB in June in settlement.

I'd like to ask about the confirmed amount in the second half, and any profit sharing from the product.

To your first question, you talk about the second-phase molecules and how we think about the planning for Phase 3. Maybe Dr.

Jin, you can talk about it, how we think about the Phase 3 study for the current molecule in Phase 2?

That's a good question. 264 has been successful development, and 264, as mentioned, we are moving from later line to first line, and also making its way to breast cancer, lung cancer, and many other tumor.

We have exploration in Phase 3, and data have been very impressive, which give us challenges in developing subsequent ADC pipelines. As I mentioned, the 410 410 is being developed by MSD globally as many Phase 2 study.

Now in the 315, which is a claudin ADC, and the bispecific ADC, which is a 570 and 500, we have reported data on ASCO. Also, B7-H3 ADC, the data on small cell lung cancer, esophageal cancer, the data are also very impressive.

We have many ideas. Very often we want to go after big indications.

We don't want to have rapid launch on the small indication. We're more interested to get into large indications.

In choosing indication for Phase 3 study and developing Phase 3 study, we are more cautious. We might prioritize developing big indications or earlier line or first line, including combining with IO or RO 2.0.

We will disclose more development plans in Phase 3 study. Now, second question for MedLink settlement, well, we already made announcements.

We have six molecules, where historically or in the future, every payment will be shared with us by certain proportion.

Next question, Mr. Huang Bo?

A quick question. You got the ADC on the conjugate, you have a lot of development plans.

What about degraders, cytotoxin combination, or the IO plus cytotoxin? What kind of specific development stage are we at now?

When are we going to see this kind of PoC experiment?

For different payload combination, there are a few things. IO plus cytotoxin, we already have one project in clinical studies on patients.

Degrader plus cytotoxin is another important strategy, because degrader, you have seen we have some patent disclosure, which is a very important direction. Dr.

Yu, maybe you can add to it. There are two levels.

For degrader development, we have some consideration. The degrader itself, from Kelun-Biotech, we have done some work on it over the years.

Also our degrader is called DAC, which is a mechanism of dual targeting. On top of the degrader ADC, we are combining with cytotoxin, which is actually taking it further.

DAC also put on top of cytotoxin. That's making ADC more interesting.

ADC is just a delivery system, right? We have a lot of potential to come up with different structure to combine with different mechanisms for synergies.

Dr. Yu?

Let me add to it. Our ADC platform and our understanding of payload is no longer using payload that we used to.

We talk about degrader, we have a immunostimulator, and even have small molecule. We're trying to put them as a payload.

We are not simply developing something and just add on different stuff in theory. There's a lot to be verified.

Our goal is that by putting two payload together, by putting two molecule together, there has to be differentiation. There has to be a better ADC, better efficacy, or even better safety.

Safety is a bottom line. It has to be safe.

We want to have more efficacy to overcome the tumor heterogeneity with better PFS and OS. Before launching to clinical study, we have to fully verify.

This is the biggest priority that we're doing now. When can we proceed to PoC?

Dr. Zhou mentioned we are now about to enter clinical Phase 1, and subsequently there will be project coming out.

Andy, you also have your hand up?

I think for MSD in their overseas clinical study, maybe you're not in a position to comment on MSD, but the market is interested in the first-line non-small cell lung cancer, particularly PD-L1 below 50%. You have two large clinical Phase 3 study in China with positive results.

MSD talk about some idea that they likely want to expand into that direction? In terms of partnership with MSD, as you say, MSD, they decide their Phase 3 study is up to them.

It will be up to MSD. I believe in recent MSD earning calls, a lot of investors were asking them.

I think MSD has provided a very good answer already. The Lung-05, Lung-06, I think they have been published data, right?

Lung-06, there will be data publication the second half of the year. For this data, it's a very good reference and inspiration for MSD.

Also for themselves, lung cancer is really the key to MSD. Like Keytruda, a lot of revenue of Keytruda come from lung cancer indication.

I'm sure MSD take it very seriously. When they're responding to investors, they already talk about their plans.

Actually in the partnership with MSD, the reason why we have a joint steering committee, that's really because for the study, for us to engage, and for the data that we acquire from the study will be shared. We are not in a position to review our strategy.

I think they previously they use a name like cornerstone. Sac-TMT is called a cornerstone for other product development.

Sac-TMT is going to be adopted in large indications, even for the first line. They do have the plans with or without Keytruda, in combining with bispecific or other molecule, they will consider heavily on sac-TMT.

I just want to add on. Mr.

Ge said it very well. Even though our data would not be presented at ESMO until October, but actually when we got positive results, the 06, particularly the sac-TMT plus pembrolizumab, the results, compared with pembro plus chemo, the data has been shared with MSD.

A positive result has been shared with MSD. Like TROP-05, 06, the results of Phase 3 study, particularly efficacy and safety, particularly pneumonia, has given MSD a great confidence.

Like HARMONi-6 presented on ASCO, I think this is also help MSD to think about their development on lung cancer.

Thank you. A couple of days ago, Dato-DXd, they're also going to read out data, Phase 3 clinical study, second half this year or next year for Dato-DXd.

What do you think of the likely results of that?

It's only a hypothesis. How can I answer that?

What is your clinical strategy? Are you going to make some biomarker like TROP2 biomarker screening when you expanding into the first-line non-small cell lung cancer in the future?

Are you going to combine with chemo? Are you going to replace chemo with TROP2 ADC?

I understand your question. From the analyst point of view, you do take care of the sac-TMT and the all TROP2 ADC.

They have similar indications. Assuming they have a success or unsuccess results, it's not black and white.

We have to see the actual data, right? They might have a lot of certification analysis, a subgroup analysis.

Want to see what happened in the subgroup analysis, subgroup performance. You have to see the actual data publication before we make decisions or judgments.

If you just say, "Oh, if Dato-DXd to be successful or not successful," it's going to be too arbitrary. We will keep monitor if data is published.

Of course, we will happy to respond after data is published. I remember that question has been asked 2 years ago.

People asked me, "What do you think if it's successful or not?" I remember at the time I was saying, if it's not successful, people will wonder maybe TROP2 doesn't work.

People will challenge us. If it's successful, maybe it's impact your market.

So 2 years ago, I got the exact same question. I'm thinking, first of all, TROP2 has been proven successful in our case.

In our Phase 3 study, where we are proven to be best-in-class, we are very confident in this, because we are the first to have a positive results in lung cancer. Also, we are also the first in the IO plus IO ADC, also with the first to have positive results in the immuno plus ADC.

Whatever data they present, we're going to be the best.

Maybe we leave last two question for the online. We also have a lot of people raising hands, let me take it by turns.

Matthew from CLSA?

Thank you for having me. I'm Matthew from CLSA.

Two questions. First about your commercialization full-year forecast.

At the beginning of year, you mentioned you expect a doubling over last year. In the first half, you have a very nice results.

My question is, what's your commercialization revenue for the full year? Would you make changes?

Second question is sac-TMT indication. We often talk about indications.

Other than the large indication that we often talk about, what about bladder cancer? Do you have any consideration of bladder cancer, because like Datopotamab, they have a Phase 3 study on MIUC to challenge the study of EV plus pembro.

Would you consider the same for sac-TMT? Right.

For your first question, I think it's been responded before. Indeed in March, at the NDR, we have been guided for the commercialized revenue for this year.

At least we're going to double, which is the target. You can see in the first half of the year, we have excellent achievement for the target in the first half.

For the commercialization sales of the second half, in terms of more coverage, important and more education for the doctor, and better education for the patient, we are more confident in the sales in the second half. Of course, we talk about at least doubling, but we hopefully we can have better commercialization results.

Also the sac-TMT in the bladder cancer, Dr. Jin?

If you're looking at the bladder, actually sac-TMT, in the ASCO GU, we have make multiple report on the bladder cancer UC data. If you look at MSD, they started 17 Phase 3, which includes bladder cancer in second line, particularly for patient who fail EV, plus PD-1 treatment in the second line, also included in the early clinicaltrials.gov, where they register and explore sac-TMT plus pembrolizumab plus LNP4 in the EV combination.

Because MSD has a lot of experience in bladder cancer, particularly EV plus pembro, where they have very successful development, whether it's the first line or early MIBC, they have been very successful. I think they will have a lot of consideration.

They have a lot to do in bladder cancer. MSD has done a lot in bladder cancer, many global Phase 3, we did not start our own very own Phase 3 study in China, because bladder cancer is a smaller indication.

We'd like to rely on MSD for global study for bladder cancer. MSD's global Phase 3 might include center from China, probably we use the global data for China application.

Usually we won't repeat the same study for the same indication in China. Of course, lung cancer, we do separate study in China.

Also, subsequently, in the 11A, in terms of combination with 11A, what we consider in the first line, like in China, mostly in lung cancer, breast cancer, and then going beyond that, we might also think about the GI cancer, gynecology cancer, urology cancer. We'll also consider exploration the future.

Last question, Yaxing from CICC?

Thank you for having me. I'm Liu Yaxing from CICC.

I have a question for expenses and profit. You can see R&D expenses used to be focus on 264, and now you have multiple developments, Phase 2, combination, and also many other study.

What do you think of the R&D expenses in the second half of the year? Where would you invest more resources in R&D?

Also regarding profit, you have very nice adjusted net profit close to 400 million. You used to expect the company to turn the profit in 2027.

Now, based on the current profit, would you update the guidance?

Very good question. Regarding R&D expenses in the first half, as mentioned, we grew slightly year-on-year in expenses R&D, like R&D clinical, and this is in line with our clinical progress.

Structurally speaking, we maintain a very stable R&D structure. The overall expenses is the cost of R&D personnel, and the expenses from clinical trial, particularly pivotal clinical trials and R&D expenses.

Those are the major component of R&D expenses. Now R&D personnel, we now have 1,000 people in total.

They're going to be stable in the short period of time. Also, the clinical trials, now even if you have more late-stage clinical trials, the cost is on a rolling basis, because it's still going to be gradually accruing and booked.

We expect R&D expenses to maintain a rather stable state. You look at what happened in the last 3 years, you are seeing a slight growth every year.

That's on R&D expense. Now regarding breaking even, as we understand, the market is very interested.

Mr. Ge has talked about it, Kelun-Biotech, we are now seeing the momentum of commercialization as opportunity.

In the early stage, we're called a biopharma, we're now converting to a biopharma. We are now in the transition phase.

There's going to be a major change in the business structure. In terms revenue, in the past, we're mainly having revenue from collaboration in R&D.

Now we have more revenue from commercialization, the revenue is more diverse, and we're going to have more cash inflow from commercialization. This will gradually build up our profit.

It was mentioned, if the collaboration become deeper, and also the sac-TMT is going to be launched in US next year, this also going to trigger the commercialization milestone, including development milestone, commercial milestone, and commercial royalties, which will bring us very nice profit and income for the company in the future. As for the breaking even, the company is now driven by two wheels.

We have a two-wheel drive profit model, breaking even won't take long. Whether it's going to be this year or next year, I think that depends on the actual business performance.

I think from the market, from the investor, analysts, I think you want to see the company a long-term breakeven. When the company broke even, this is going to be a commitment to the market.

We're going to tell the market that from now on, you can expect long-term profitability. That is the breakeven that we want to achieve.

That's a real breakeven. For R&D, I'd like to add in the first half, R&D increased by 25% year-on-year, R&D expenses, I think that's a good question.

You can see the change of R&D investment.

In the past, R&D was focused on 264 ADC, which is mostly the R&D expenses for ADC 264. In the future, it's going to include two parts.

ADC plus IO, further combination with ADC plus IO. Secondly, we're going to have many Phase 2 study.

Another important development is the new type of ADC, new type of technology, new conjugation technology in clinical study. In the second half, I agree with Mr.

Zhou, you might have a slight growth in the second half or maybe stable in the second half, but in the future, you can expect growth for R&D expenses. Those R&D investment will provide greater momentum for the future growth and development for the company.

That's the time we have for the day, and that will concludes our interim results presentation. Any more question, happy to take them offline.

In the coming days, the company management will have roadshow in Hong Kong and other cities. Mr.

Ge, can I ask you for a final review?

Thank you for the time. We have overrun quite a bit.

During presentation, the management overrun by a few minutes, but then more importantly, you asked many good questions. Those are very nice questions.

The questions are great because it give us opportunity to present our strategy, and present the products, and present the prospect of the pipelines. I think it is also beneficial for us, because in the interim results, annual results presentation, I think investors has been able to provide feedbacks, which in turn to be great guidance to us, so that in terms of the future R&D project, pipeline, and clinical indication development, your question provide good guidance.

Thank you very much. Thank you for the time.

Thank you.