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Shanghai Henlius Biotech, Inc. Class H ( (HK:2696) ) has shared an update.
Shanghai Henlius Biotech has announced that its pertuzumab biosimilar HLX11 has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, recommending approval for multiple HER2‑positive breast cancer indications in combination therapies. The CHMP backing, supported by data demonstrating high similarity to reference drug Perjeta in quality, safety and efficacy and by EU GMP certification of its production lines, positions Henlius to enter a global pertuzumab market worth about US$3.3 billion once the European Commission issues its final decision and complements recent regulatory progress in China, North America and other key regions.
If cleared by the European Commission, HLX11 would gain centralized marketing authorization across all EU member states and EEA countries, significantly expanding its commercial footprint beyond the already approved U.S. market. Combined with its global licensing agreement with Organon and ongoing filings in China and Canada, the product’s advancing regulatory status underlines Henlius’s growing presence in the global oncology biosimilars arena and could enhance revenue prospects for both the company and its commercial partner.
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 manufacturing monoclonal antibody therapies and biosimilars. The company’s pipeline targets major oncology indications and global markets, leveraging partnerships such as its global (ex‑Greater China) commercialisation deal with Organon for its pertuzumab biosimilar HLX11.
Average Trading Volume: 902,432
Technical Sentiment Signal: Strong Buy
Current Market Cap: HK$50.83B
Find detailed analytics on 2696 stock on TipRanks’ Stock Analysis page.