亿帆医药：子公司在研产品N-3C01注射液获得临床试验批准通知书

Core Viewpoint - Yifan Pharmaceutical (002019.SZ) announced that its wholly-owned subsidiary Hefei Xinzhu Biotechnology Co., Ltd. received approval from the National Medical Products Administration for clinical trials of the innovative macromolecule drug N-3C01 injection, aimed at treating advanced solid tumors and non-muscle invasive bladder cancer (NMIBC) [1] Group 1: Drug Development - N-3C01 is a recombinant IL-15/IL-15Rα fusion protein produced using DNA recombinant technology [1] - The drug activates NK cells and cytotoxic T cells, enhancing their anti-tumor efficacy through the binding of IL-15 with immune effector cell receptors [1] - Preclinical studies indicate that N-3C01 can activate human NK cells and CD8+ T cells in vitro, and it shows a dose-dependent tumor growth inhibition in mouse models [1] Group 2: Safety and Efficacy - N-3C01 demonstrated good safety profiles in short-term and long-term safety trials conducted on rats and monkeys [1]