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Henlius Wins NMPA Nod to Start Trials of Daratumumab Biosimilar HLX15-SC

Story Highlights
  • Henlius secured NMPA approval to launch a phase 1 trial of HLX15-SC, a subcutaneous anti-CD38 monoclonal antibody for multiple myeloma.
  • The HLX15 program targets the multibillion-dollar daratumumab market, potentially strengthening Henlius’s oncology biologics position if development succeeds.
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Henlius Wins NMPA Nod to Start Trials of Daratumumab Biosimilar HLX15-SC

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An update from Shanghai Henlius Biotech, Inc. Class H ( (HK:2696) ) is now available.

Shanghai Henlius Biotech has obtained approval from China’s National Medical Products Administration for the investigational new drug application of HLX15-SC, a subcutaneous recombinant anti-CD38 fully human monoclonal antibody, to begin a phase 1 clinical trial in multiple myeloma. The product is a subcutaneous formulation of HLX15, a biosimilar candidate to daratumumab that the company is independently developing for multiple myeloma and other potential indications.

The authorisation to proceed with clinical development positions Henlius to compete in the lucrative anti-CD38 multiple myeloma market, where originator drug daratumumab recorded global sales of about US$12.88 billion in 2024. Successful progress of HLX15-SC and the related intravenous formulation could enhance the company’s presence in oncology biologics, though management cautions that development and commercialisation outcomes remain uncertain.

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 commercialising biologic medicines, including biosimilar monoclonal antibodies. Its pipeline targets oncology and other serious diseases, aiming to provide cost-effective alternatives to established biologic therapies in global markets.

Average Trading Volume: 913,824

Technical Sentiment Signal: Buy

Current Market Cap: HK$48.69B

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