Mr. LIU Gexin
Chairman of the Board
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) (hereinafter referred to as "Kelun-Biotech" or the "Company") is a biopharmaceutical company committed to the R&D, manufacturing and commercialization of innovative drugs. Since its incorporation in 2016, Kelun-Biotech has been committed to addressing medical needs in China and globally. Empowered by our integrated drug development capabilities and a well-established management systems that covers all key business functionalities, Kelun-Biotech is dedicated to the in-house development of differentiated treatments to improve the existing standard of medical care. As one of the pioneers and innovators in the development of antibody drug conjugates (ADCs), Kelun-Biotech has accumulated more than ten years of experience in ADC development and is one of the first biopharmaceutical companies in China, and one of the few globally, to establish an integrated ADC and novel DC platform, OptiDCTM.
The Company takes a systematic, indication-oriented approach to target the world's prevalent or hard-to-treat cancers, and other diseases and conditions affecting a large and underserved population. Over the years, the Company has developed integrated capabilities encompassing all key drug development functionalities, including research and development, manufacturing, quality management and commercialization. The Company’s capabilities empower us to rapidly and strategically advance a differentiated pipeline of over 30 assets, including over 10 in clinical stage. Supported by three in-house developed technology platforms, Kelun-Biotech has proprietary know-how in ADCs and novel DCs, biologics (monoclonal antibodies (mAbs) and bispecific antibodies (bsAbs)), as well as small molecule drugs. This approach has been thoroughly tested and fully validated through pre-marketing clinical trials and large-scale post-launch clinical application of multiple products.The Company has built a strong pipeline with diversified and synergistic effects in terms of drug modalities, mechanisms and indication coverage.
The Company have received marketing authorization for sac-TMT (佳泰莱®), tagitanlimab (科泰莱®), Cetuximab N01 (达泰莱®) and trastuzumab botidotin (舒泰莱®) and have commenced their commercialization. The Company have also filed an NDA for Lunbotinib Fumarate Capsules (宁泰莱®) and expect to commence its commercialization in the first half of 2027, subject to regulatory communications and marketing approval. Driven by recognition from expert of high-quality clinical data and shift in treatment Paradigms, as well as comprehensive enhancement of drug accessibility, the Company’s commercialization growth momentum continues to accelerate, with total revenue from sales of pharmaceutical products reaching RMB657.04 million for the first half of 2026, up by 112% compared to the same period last year.
At the same time, the clinical value of Kelun-Biotech's pipeline and its drug development capabilities are recognized by the strategic partnerships worldwide. To date, The Company have entered into multiple license and collaboration agreements, including those with Merck Sharp & Dohme LLC (“MSD”, a wholly-owned subsidiary of Merck & Co., Inc.) to develop multiple ADC assets for cancer treatment. The Company have also established in-depth collaborations with pharmaceutical companies including Ellipses Pharma, Windward Bio and Crescent Biopharma. These strategic partnerships are not only testaments to our R&D and business development capabilities, but also are key drivers of our continued innovation, global influence and long-term growth.
The Company have fully integrated AI into several R&D processes to further improve R&D efficiency: (i)Antibody. AI-assisted humanization and affinity maturation, AI-driven full-range structural optimization, physicochemical optimization, and immunogenicity and binding site prediction; (ii)Small Molecules. AIDD technologies are now driving fundamental innovation in small-molecule platforms and have facilitated the efficient discovery of multiple novel scaffolds with significant differentiation advantages; (iii) Target/Antigen. AI tools are adopted to conduct target gene bioinformatic analysis and multi-species gene expression analysis; (iv) Translational Medicine. Through the use of commercial AI databases and self-built AI platforms, the company have optimized the gene pathway analysis and validation as well as toxicity mechanism prediction of innovative targets, molecular dynamics simulation and thermal stability prediction for biologics, and improved the risk control methods of innovative R&D; and (v) Clinical Research. An intelligent risk monitoring platform has been developed using AI tools to accurately assess and guide clinical monitoring frontline work; in addition, the development of AI-assisted programming languages has effectively improved the work efficiency.
Going forward, Kelun-Biotech strives to advance five strategic priorities: (i) advancing our differentiated pipelines targeting indications with significant medical needs; (ii) innovating on optimized payload-linker strategies, novel DC designs and structures, and expanded application to non-oncology diseases; (iii) enhancing our end-to-end drug development and commercialization capabilities; (iv) expanding business landscape and strategic partnerships and improving our capabilities for the development, registration and commercialization of our products in ex-China market; and (v) optimizing our operation system to become a leading global biopharmaceutical company.
