Core Viewpoint - The company has received approval from the National Medical Products Administration (NMPA) for its self-developed HLX15-SC, a subcutaneous injection of a recombinant anti-CD38 fully human monoclonal antibody, for the treatment of multiple myeloma [1] Group 1: Product Development - HLX15 is a biosimilar to daratumumab, designed for the treatment of multiple myeloma (MM) [1] - The mechanism of action for daratumumab includes binding to CD38 on tumor cells, inducing apoptosis through various immune-related mechanisms such as complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP) [1] - The company successfully completed a Phase I clinical study of HLX15-IV (intravenous formulation) in healthy male subjects in China in June 2024 [1] Group 2: Market Potential - According to IQVIA MIDAS, the global sales of daratumumab are projected to be approximately $12.88 billion in 2024 [1]
复宏汉霖自主研发的HLX15-SC用于多发性骨髓瘤治疗的1期临床试验申请获NMPA批准