Henlius Wins U.S. FDA IND Nod for Multiple Myeloma Biosimilar HLX15-SC

Shanghai Henlius Biotech, Inc. Class H ( (HK:2696) ) has shared an update.

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. 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 Henlius’ 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. In addition, Henlius has licensed Dr. Reddy’s Laboratories 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.

The most recent analyst rating on (HK:2696) stock is a Hold with a HK$64.00 price target. To see the full list of analyst forecasts on Shanghai Henlius Biotech, Inc. Class H stock, see the HK:2696 Stock Forecast page.

More about Shanghai Henlius Biotech, Inc. Class H

Shanghai Henlius Biotech, Inc. 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.

Average Trading Volume: 955,526

Technical Sentiment Signal: Strong Buy

Current Market Cap: HK$51.08B

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