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Henlius Wins NMPA Nod to Begin Trials of HER2 Breast Cancer Biosimilar HLX319

Story Highlights
  • Henlius secured NMPA approval to start phase 1 trials of HLX319, a subcutaneous pertuzumab-trastuzumab biosimilar for HER2-positive breast cancer.
  • Positive preclinical similarity data and a multibillion-dollar reference market position HLX319 as a potential growth driver, though development success is not assured.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Henlius Wins NMPA Nod to Begin Trials of HER2 Breast Cancer Biosimilar HLX319

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The latest update is out from Shanghai Henlius Biotech, Inc. Class H ( (HK:2696) ).

Shanghai Henlius Biotech has received approval from China’s National Medical Products Administration for investigational new drug applications to begin phase 1 clinical trials of HLX319, a subcutaneous biosimilar injection combining pertuzumab and trastuzumab. HLX319 is intended for adjuvant or neoadjuvant treatment of early-stage breast cancer and for metastatic breast cancer, using a fixed-dose combination that targets different HER2 epitopes to enhance antitumor effects.

The company’s preclinical studies showed HLX319 to be similar to the reference subcutaneous pertuzumab and trastuzumab injection in pharmacodynamics, pharmacokinetics and toxicology, aligning with Chinese, EU and U.S. biosimilar guidelines. Entering clinical trials in a segment where global sales of the reference product reached about USD3.0 billion in 2025 could strengthen Henlius’s presence in the breast cancer biologics market, though the company cautions there is no guarantee of successful development or commercialization.

The most recent analyst rating on (HK:2696) stock is a Buy with a HK$99.78 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 specializing in the independent development of biosimilar and innovative biologic drugs. The company focuses on oncology and other therapeutic areas, targeting major global markets with antibody-based therapies and combination formulations to address significant unmet medical needs.

Average Trading Volume: 1,019,935

Technical Sentiment Signal: Strong Buy

Current Market Cap: HK$25.25B

For detailed information about 2696 stock, go to TipRanks’ Stock Analysis page.

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