亿帆医药(002019.SZ)：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) has received approval from the National Medical Products Administration for clinical trials of its innovative macromolecule drug N-3C01 injection, aimed at treating advanced solid tumors and non-muscle invasive bladder cancer (NMIBC) [1] Group 1: Drug Development - The drug N-3C01 is a recombinant IL-15/IL-15Rα fusion protein developed using DNA recombinant technology [1] - N-3C01 activates NK cells and CD8+ T cells, enhancing their anti-tumor efficacy, as demonstrated in preclinical studies [1] - The drug has shown a dose-dependent ability to inhibit tumor growth in mouse models [1] Group 2: Safety and Efficacy - N-3C01 has demonstrated good safety profiles in short-term and long-term safety trials conducted on rats and monkeys [1] - The mechanism of action involves simulating the binding of IL-15 to immune effector cell receptors, thereby activating immune responses against tumors [1]