华东医药：注射用 HDM2012 获得药物临床试验批准通知书

Core Viewpoint - Huadong Medicine (000963) announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for the clinical trial of HDM2012, a novel antibody-drug conjugate targeting Mucin17 (MUC-17) [1] Company Summary - HDM2012 is an innovative antibody-drug conjugate (ADC) developed independently by Huadong Medicine, consisting of an anti-MUC-17 monoclonal antibody linked to a topoisomerase I inhibitor via a cleavable linker, with a drug-antibody ratio (DAR) of 8 [1] - The product is a first-in-class biological product globally, with Huadong Medicine holding worldwide intellectual property rights [1] - HDM2012 specifically targets MUC-17 positive tumor surface antigens, facilitating internalization into tumor cells and releasing cytotoxic agents to exert anti-tumor effects [1] - Preclinical studies indicate that HDM2012 demonstrates good drug-like properties, safety, and efficacy [1]