Morning, everyone. Thank you for joining this session at APAC Track. I'm Yang, a China healthcare analyst at JP Morgan. Next, our presentation company will be Kelun-Biotech. So joining us will be Dr. Michael Ge, CEO of Kelun-Biotech. Let's welcome Dr. Ge.
Okay. Good morning, ladies and gentlemen. Thank you for joining us this morning, and thank you for having me to this event. My name is Michael Ge, the President and the CEO of Kelun-Biotech. First of all, as we will be making forward-looking statements, I'll refer you on the screen here. Kelun-Biotech is a biopharmaceutical company which is committed to the research, development, manufacturing, and commercialization of the novel drugs in oncology, immunology, metabolism, and other disease therapeutic areas. Kelun Pharmaceutical is our largest shareholder, and MSD is the second largest shareholder and the major collaborator. Since our founding more than 10 years ago, Kelun-Biotech has emerged as a leader in the innovative drug R&D industry in China with a truly differentiated technology platform and pipeline programs. Central to our R&D engine is our world-class drug-conjugate technology platform, renamed as OptiDC.
To date, we have over 30 pipeline programs and developments, including four approved products with seven indications, two products with two indications at the NDA stage, and over 10 programs in clinical development. We expect more product approvals and label expansions in 2026. As of December of 2025, we have around 2,000 employees, which makes us one of the largest Chinese biotech companies. Of the 2,000 employees, about 900 are R&D professionals, 500 are in the manufacturing and quality control, and about 500 are in the sales and marketing in China. This slide shows an overview of our pipeline programs. We have four launched products, and another one in the NDA stage is the next-generation RET inhibitor as a small molecule product. Our TROP2 ADC, the sac-TMT, was launched in China in November of 2024, which is also the first TROP2 ADC approved for the lung cancer treatment globally.
So far, it has been approved for three indications in China: 2L+ TNBC, second- line, and third line EGFR- mutant in non-small cell lung cancer. Our HER2-ADC, trastuzumab botidotin, was just approved last October, which is actually the first domestically developed HER2-ADC approved for HER2-positive breast cancer in China. We also have Cetuximab N01, this for RAS wild-type CRC, and PD-L1 for NPC available on the market. Apart from TROP2 ADC and HER2-ADC, we also have nine novel drug conjugates at the clinical stage with differentiated targeting, payload-linked design, and a novel compound structure, including our first bispecific ADC, SKB571, and our first radionuclide RDC, the drug conjugate, SKB107. Our China clinical development mostly focuses on the top oncology indications with a large patient population, such as breast cancer, lung cancer, and gastrointestinal cancer.
We have initiated five pivotal clinical studies for breast cancer, six for lung cancer, and one for GI with our TROP2 ADC, HER2-ADC, Cetuximab N01, and the RET inhibitor. Some of them were already approved last year in China. We are also exploring the opportunities for other indications in phase I or phase II, such as gynecological or genitourinary cancer. In addition, there are significant pipelines at the phase I or phase II stage, which we are expected to move into pivotal studies in the upcoming years, subject to their escalation and expansion study data. In 2025, we have presented clinical data for six pivotal studies, as well as a series of phase I and phase II studies at various academic conferences and published in international renowned journals. Notably, our OPTITROP-Lung04 study is the study result for second- line EGFR mutant non-small cell lung cancer.
We presented it in the Presidential Symposium at ESMO 2025 and were simultaneously published in the New England Journal of Medicine. Read-outs from parts of these studies will be introduced to you in the later slides. We have got four products approved in China and expect to get our small molecule RET inhibitor approved this year. So these five products comprise our first batch of our commercial products with primary focus on the BC, LC, and GI cancer. The indication concentration will bring us some synergy from a marketing perspective. We also have set up a full-fledged commercialization team with access to all Class III hospitals as well as key opinion leaders. We expect to further expand our commercial team along with more products and indications approved in upcoming years.
Per the press release by the National Healthcare Security Administration, our three core products have been included in the national reimbursement drug list, which is called NRDL 2025, which has taken effect since this month. We have attached great importance to global partnership and collaboration, which we regard as the best way to bring our pipelines to the world, to the global market. It can maximize our pipeline's value and corporate value. We also have entered into a few out-license agreements and collaborations with MSD, Ellipses, Windward Bio, and Crescent Bio in the past years. MSD, as just mentioned, is our second largest shareholder and is our major collaborator, also our strategic partner. Through the collaborated ADC pipelines, we aim to cover a wide range of tumor indications via different targets with differentiated payload linkage strategies.
In last December, we announced the partnership with Crescent Bio to develop and commercialize novel oncology therapies, including SKB105, an ITGB6 ADC, and CR001, the PD-1/ VEGF bispecific antibody. In the next few slides, I will elaborate on our launch ADC products and GI pipelines. Firstly, our lead program, a TROP2 ADC, is also known as sac-TMT. In China, clinical development of sac-TMT is mostly focused on lung cancer and breast cancer, the two largest oncology indications. sac-TMT has been approved for second- line TNBC, second- line and third- line EGFR mutant non-small cell lung cancer in China. We also filed the NDAs for second-l ine HR- positive, HER2- negative breast cancer last year. There are five phase III trials for first- line breast cancer and lung cancer ongoing in China.
Meanwhile, our partner, MSD, is initiating 16 global phase III studies as monotherapy or in combo for lung, breast, gastric, and gynecology cancers, ranging from second- line, third- line, to first- line, and even adjuvant and neoadjuvant. The earliest data of the global phase III study readouts is expected this year. Given the differentiated design, sac-TMT has demonstrated best-in-class performance in both efficacy and safety profile. Just as the day before yesterday, the President of Merck, Dr. Dean Li, said, "Our product is the best in class." Don't ask why, because the linkage is some is loose, some is tight. Maybe ours is just right. Four China-based phase III study results have been unveiled at ASCO- ESMO last year.
Sac-TMT as the chemotherapy versus as the monotherapy versus the chemotherapy for second-l ine and third line lung cancer and breast cancer benefits the patients with not just higher response rates and longer PFS, but also significant extension of overall survival. For example, the second- line EGFR mutant non-small cell lung cancer, sac-TMT versus the platinum plus pemetrexed, the PFS HR is 0.49x. The OS HR is 0.6x. Even the MOS of sac-TMT group was not reached at the cut-off date. Based on the statistical forecasting, the MOS is expected to significantly extend on the top of the control arm. For the other studies, you can see a steep trend for the third line EGFR mutant small cell lung cancer, for the second- line TNBC, and also for the NDA stage, the second- line HR- positive, HER2- negative breast cancer.
The next product is our HER2-ADC, utilizes the vc-MMAF structure with a potent cytotoxin as its payload and demonstrated strong tumor killing ability even in a low DAR setting. Trastuzumab botidotin was just approved last October for second-line+ HER2-positive breast cancer. The phase III study results were unveiled at ESMO 2025. Compared with the T-DM1, our HER2-ADC is shown to significantly improve the PFS with the HR 0.39x and the ORR with 77%. OS benefit trend was also observed. Given the differentiated payload-linker design and the safety profile, our HER2-ADC is positioned to treat patients who are either intolerant or resistant to the T-DM1-based HER2-ADC. Our TROP2 ADC and HER2-ADC have well covered lung cancer and breast cancer treatments. We also advance in multiple development pipelines in the third largest indications in oncology, gastrointestinal cancer.
Our first progress, our Cetuximab N01, has been approved for the first- line treatment of RAS wild-type colorectal cancer. Meanwhile, we are also developing ADC pipelines for GI treatment. The phase II data of our Claudin 18.2 ADC and TROP2 ADC for the gastric cancer has been unveiled at ESMO and AACR. There are also a few other ADC pipelines and developments with the potential for GI cancer treatment, given their target expression on the colorectal and pancreatic tumor cells, such as the SKB571, SKB535, SKB500, and SKB105. In the next few pages, I will give an overview of our innovation capabilities and strategies. As mentioned, we have more than 10 years of experience in ADC discovery and development area. We named our drug conjugate platform as OptiDC, which means optimized drug conjugate.
We have tailored the design of every drug candidate with the consideration of the characteristics of a specific target or targeting mechanism and adopt the most suitable payload link strategy to best balance the efficacy and the safety profile. We also have the integrated capabilities of the R&D and manufacturing to help the development and for the life cycle development of the ADCs. With our team's experience and knowledge base, we adopt a multi-pronged strategy to further advance our OptiDC platform. For oncology treatments, typically ADC is regarded as a replacement for traditional chemotherapy. That's why we are developing novel targets or with bispecific antibody structure. And also, we are expanding payloads beyond the common topoisomerase I and tubulin inhibitors, including using the dual payloads. We are also exploring non-toxin-based drug conjugates with either radioisotope or protein degrader, or the immunomodulator as the payloads.
Beyond oncology, we are also applying our experience and know-how to develop non-oncology ADCs for autoimmune and metabolic diseases. The ADC structure could potentially combine the biologicals and small molecules in novel targeting mechanism, resulting in better safety window as well as efficacy to patients with chronic diseases. As I conclude this presentation, I would like to highlight the following formalized growth plans. Our top priority is still to rapidly advance our differentiated pipeline programs with significant medical needs. Secondly, we will continue to innovate and optimize our ADC platform, discover the novel payloads, linkers, engineer novel ADC designs, and expand the clinical applications of drug conjugates to non-oncology disease areas. Our third focus is to build upon and expand our end-to-end drug development, manufacturing, and commercialization capabilities.
Lastly, we are gradually expanding our business landscape through our strategic partnerships globally and improving our capabilities for the development, registration, and commercialization of our products in ex-China markets. This will be all my presentation today. Thank you for your time. Thank you.