Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has received approval from the National Medical Products Administration (NMPA) for its IND application for HLX15-SC, a subcutaneous injection of a recombinant anti-CD38 fully human monoclonal antibody, aimed at treating multiple myeloma (MM) [1] Group 1: Product Development - HLX15-SC is a biosimilar to daratumumab, a humanized anti-CD38 IgG1κ monoclonal antibody, which binds to CD38 expressed on tumor cells [1] - The mechanism of action includes complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP), leading to tumor cell apoptosis [1] - The company has also completed a Phase I clinical study of HLX15-IV (intravenous formulation) in healthy male subjects in China in June 2024 [1]
复宏汉霖(02696.HK)：HLX15-SC用于多发性骨髓瘤治疗的临床试验申请获国家药监局批准