Shanghai Henlius Receives FDA Approval for Phase 1 Trial of Multiple Myeloma Biosimilar

Shanghai Henlius Biotech has secured U.S. FDA approval of an investigational new drug application for a phase 1 clinical trial of HLX15-SC, a subcutaneous formulation of its fully human anti-CD38 monoclonal antibody for the treatment of multiple myeloma. The approval allows the company to begin phase 1 trials in the United States.

HLX15 is a biosimilar of daratumumab, a blockbuster CD38-targeting therapy with 2024 global sales of about US$12.88 billion, underscoring the significant commercial potential of the candidate.

The company has previously completed a phase 1 trial of the intravenous version HLX15-IV in healthy Chinese male subjects and obtained Chinese IND clearance for HLX15-SC, positioning it to run clinical programs in both China and the U.S.

Henlius has licensed exclusive rights to commercialize HLX15 in the United States and 42 European countries, highlighting a strategic push into key oncology markets despite typical development and regulatory risks.

Shanghai Henlius Biotech is a China-based biopharmaceutical company focused on developing and commercializing biologic drugs, including biosimilars and innovative monoclonal antibody therapies. Its pipeline targets oncology and immune-related diseases, with an expanding international footprint through licensing deals in major markets such as the United States and Europe.