Kelun-Biotech ADC Innovator SKB518 for Advanced Solid Tumors Receives CDE Clinical Trial Approval Notification
2024-06-18 · Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · original kelun-biotech.com ↗
("Kelun-Biotech" or the "Company", SEHK: 6990.HK) announces that the Company has received a Notice of Clinical Trial Approval (IND) for SKB518, an innovative ADC drug developed by the Company, in patients with advanced solid tumors from the Center for Drug Evaluation (CDE) of the State Drug Administration (NDA). (CDE) of the National Drug Administration (NMPA) for the approval of the clinical trial application (IND) of SKB518 for injection, an innovative ADC drug developed by the Company, to conduct clinical trials in patients with advanced solid tumors. SKB518 for injection is an innovative antibody-coupled drug with proprietary intellectual property rights developed by the Company by utilizing the "OptiDC?" platform technology in light of the biological characteristics of the target site, and it has demonstrated good efficacy and safety window in the preclinical stage. Dr. Junyou Ge, Chief Executive Officer of Kelun-Biotech, said, "The entry of SKB518 into clinical trials enriches Kelun-Biotech's clinical product portfolio in the field of oncology ADC therapeutics, and paves a broader path for the company's flexible development of future pipelines in the oncology field. We are simultaneously accelerating the independent research and development of more than 10 preclinical-stage ADCs and novel coupling technology drug assets, and this year we plan to continue to file clinical INDs for a number of preclinical ADC pipelines." About Kelun-Biotech Kelun-Biotech ( 6990.HK ) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing innovative projects in major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, including over 10 projects in the clinical stage and 4 projects in the NDA stage with several global trials being conducted simultaneously in multiple countries, including China, Europe, and the United States. The company has established one of the world’s leading proprietary ADC platforms, OptiDC?, and has 5 ADC projects in the clinical stage (2 of which are in the NDA stage) and several projects in the preclinical stage. For more information, please visit https://kelun-biotech.com/ .
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