HENLIUS (02696) obtained NMPA approval for the Phase 1 clinical trial application of the HLX15-SC developed for the treatment of multiple myeloma.

HENLIUS (02696) announced that recently, the company's self-developed HLX15-SC (recombinant anti-CD38 human monoclonal antibody injection - subcutaneous injection) for the treatment of multiple myeloma has been approved for phase 1 clinical trial application (IND) by the National Medical Products Administration (NMPA). It is reported that HLX15 (recombinant anti-CD38 human monoclonal antibody) is a daratumumab biosimilar developed independently by the company, intended for the treatment of multiple myeloma (MM) and other conditions. Daratumumab is a humanized IgG1 monoclonal antibody against CD38 that can bind to CD38 expressed on the surface of tumor cells, inducing tumor cell apoptosis through complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), Fc receptor-mediated mechanisms, and other immune-related mechanisms. In addition, daratumumab can also reduce MM cells by lowering myeloid suppressor cells and depleting immunoregulatory T and B cells expressing CD38. In June 2024, a Phase 1 clinical study of HLX15-IV (intravenous injection formulation) in Chinese male healthy volunteers was successfully completed. According to data from IQVIA MIDAS (IQVIA is a global provider of professional information and strategic consulting services in the pharmaceutical and healthcare industries), in 2024, the global sales of daratumumab were approximately $12.88 billion.