Shanghai Henlius Biotech, Inc. (2696) announced that its investigational new drug application for HLX15-SC (recombinant anti-CD38 fully human monoclonal antibody injection – subcutaneous injection) has been approved by the National Medical Products Administration for a phase 1 clinical trial targeting multiple myeloma. According to the announcement dated 12 February 2026, HLX15-SC was developed independently by the company and represents a subcutaneous formulation of HLX15, a proposed biosimilar to daratumumab.

HLX15 is designed to bind CD38 expressed on the surface of tumor cells, inducing tumor apoptosis through complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and other immune-related mechanisms. The company completed a phase 1 clinical study of the intravenous version (HLX15-IV) in healthy Chinese male subjects in June 2024, and now plans to advance HLX15-SC into clinical development. Market data from IQVIA indicates that global sales of daratumumab reached approximately US$12.88 billion in 2024.

The announcement highlights that Shanghai Henlius Biotech, Inc. cannot guarantee the successful development and commercialization of HLX15, advising shareholders and potential investors to approach the company’s shares with caution.