Henlius Wins EU Nod for Pertuzumab Biosimilar, Expanding Global Oncology Footprint

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

Shanghai Henlius Biotech has secured European Commission approval for POHERDY, its pertuzumab biosimilar HLX11, for use in combination regimens to treat HER2-positive early and metastatic breast cancer across all EU member states and European Economic Area countries. The decision follows extensive analytical and clinical comparison data showing high similarity to reference drug Perjeta and reflects Henlius’s expanding role as a global supplier of oncology biosimilars.

The EU clearance, coming after U.S. FDA approval and pending or ongoing reviews in China and Canada, deepens Henlius’s penetration into the multibillion-dollar pertuzumab market and strengthens its international footprint. By commercializing the product with partner Organon in designated regions, the company is positioned to broaden patient access to lower-cost biologic options and reinforce its competitive position in the global oncology biosimilar segment.

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 focused on developing and manufacturing biosimilar and innovative monoclonal antibody therapies. Its portfolio targets major disease areas including oncology, with a growing emphasis on global commercialization through regional licensing partnerships, particularly in North America and Europe.

Average Trading Volume: 1,176,276

Technical Sentiment Signal: Buy

Current Market Cap: HK$44.97B

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