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Henlius Wins EU Approval for Two New Serplulimab Cancer Uses

Story Highlights
  • Shanghai Henlius secured EU approval for two new serplulimab indications in esophageal and lung cancers.
  • The expanded EU and EEA access, supported by phase 3 data and GMP compliance, boosts Henlius’s global oncology footprint and partnership value.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Henlius Wins EU Approval for Two New Serplulimab Cancer Uses

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Shanghai Henlius Biotech, Inc. Class H ( (HK:2696) ) has provided an announcement.

Shanghai Henlius Biotech announced that the European Commission has approved two new indications for its anti-PD-1 antibody serplulimab, branded as HETRONIFLY in the EU, covering first-line treatment of certain esophageal squamous cell carcinoma and non-squamous non-small cell lung cancer patients ineligible for curative local therapy. The approvals, which extend across all EU member states and EEA countries, are backed by phase 3 data showing significant benefit and acceptable safety, and follow EU GMP certification and prior CHMP support, strengthening Henlius’s international oncology portfolio and expanding commercial opportunities for serplulimab through its European and Indian licensing arrangement with Intas.

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 commercialising innovative monoclonal antibody therapies, particularly in oncology. Its lead product, the anti-PD-1 antibody serplulimab (HANSIZHUANG/HETRONIFLY), targets multiple solid tumours and has secured approvals across China, the European Union and several Asian markets, often via partnerships such as its licensing deal with Intas Pharmaceuticals for Europe and India.

Average Trading Volume: 1,016,057

Technical Sentiment Signal: Buy

Current Market Cap: HK$39.97B

Learn more about 2696 stock on TipRanks’ Stock Analysis page.

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