Core Viewpoint - The company, Junshi Biosciences, 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 - HLX15 is a biosimilar to daratumumab, designed for treating multiple myeloma (MM) [1] - Daratumumab is a humanized IgG1κ monoclonal antibody that binds to CD38 on tumor cells, inducing apoptosis through various immune mechanisms [1] - The drug also reduces MM cells by lowering myeloid-derived suppressor cells and depleting CD38 positive regulatory T and B cells [1] Group 2 - A phase I clinical study of HLX15-IV (intravenous formulation) was successfully completed in June 2024 among healthy male subjects in China [1] - According to IQVIA MIDAS, the global sales of daratumumab are projected to be approximately $12.88 billion in 2024 [1]
复宏汉霖(02696)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