Shanghai Henlius Biotech, Inc. (2696) recently received approval from the United States Food and Drug Administration for an investigational new drug (IND) application to conduct a phase 1 clinical trial of HLX15-SC, a subcutaneous injection of a recombinant anti-CD38 fully human monoclonal antibody. Dr. Reddy’s Laboratories SA, a wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd., is involved through an exclusive commercialization license agreement for HLX15 in certain regions, including the United States.

HLX15, a biosimilar of daratumumab, is designed to target CD38 expressed on the surface of tumor cells, inducing tumor apoptosis via complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and other immune-related mechanisms. According to IQVIA MIDASTM statistics, daratumumab reached worldwide sales of 12.88 billion US dollars in 2024.

Development milestones include the successful completion of a phase 1 clinical study for HLX15-IV in healthy Chinese male subjects in June 2024 and the approval of HLX15-SC by the National Medical Products Administration in February 2026. The company cautions that it cannot guarantee successful development or commercialization of HLX15 and advises shareholders and potential investors to exercise caution when dealing in its shares.