HENLIUS (02696) announced that the Investigational New Drug (IND) application for the Phase 1 clinical trial of its self-developed HLX15-SC (recombinant fully human anti-CD38 monoclonal antibody subcutaneous injection) for the treatment of multiple myeloma has been approved by the U.S. Food and Drug Administration (FDA). HLX15 is the company's proprietary biosimilar of daratumumab, intended for treating conditions such as multiple myeloma (MM). Daratumumab is a humanized anti-CD38 IgG1κ monoclonal antibody that binds to CD38 expressed on the surface of tumor cells, inducing tumor cell apoptosis through various immune-related mechanisms, including complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and Fcγ receptor interactions. Additionally, daratumumab can reduce MM cells by diminishing myeloid-derived suppressor cells and depleting CD38-positive regulatory T and B cells. In June 2024, the Phase 1 clinical study of HLX15-IV (intravenous formulation) in healthy male subjects in China was successfully completed. In February 2026, the IND application for the Phase 1 clinical trial of HLX15-SC for multiple myeloma was approved by the National Medical Products Administration (NMPA) of China. In February 2025, the company entered into a licensing agreement with Dr. Reddy’s Laboratories SA, a wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd., granting Dr. Reddy’s an exclusive license to commercialize HLX15 (including both intravenous and subcutaneous formulations) in the United States and specified European territories, including the UK, Switzerland, and 42 other European countries. According to data from IQVIA MIDAS™, a global provider of professional information and strategic consulting services for the pharmaceutical and healthcare industry, global sales of daratumumab reached approximately $12.88 billion in 2024.