Henlius Wins Key EMA Backing for Serplulimab Lung Cancer Use

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

Shanghai Henlius Biotech said its anti-PD-1 monoclonal antibody serplulimab, marketed as HANSIZHUANG in China and HETRONIFLY in the EU, has received a positive opinion from the European Medicines Agency’s CHMP for use with carboplatin and nab-paclitaxel as a first-line treatment for unresectable, locally advanced or metastatic squamous non-small cell lung cancer. If endorsed by the European Commission, the centralised approval would extend across the EU and EEA and deepen Henlius’s oncology footprint, leveraging phase 3 data showing significant efficacy and acceptable safety, existing EU GMP-certified manufacturing, wide global registrations, Orphan Drug designations, and an ongoing global clinical program and commercialisation alliance with Intas to support broader adoption and further expansion of serplulimab’s cancer indications.

The CHMP’s positive view is based on a randomized, double-blind, international phase 3 trial demonstrating that serplulimab plus chemotherapy significantly improved outcomes in first-line squamous non-small cell lung cancer with good tolerability. Together with prior approvals in small cell lung cancer, esophageal squamous cell carcinoma and non-squamous non-small cell lung cancer, as well as ongoing late-stage studies in lung, gastric, colorectal and head and neck cancers, the new indication would reinforce Henlius’s position in the global immuno-oncology market and could enhance revenue streams across Europe and other licensed territories.

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 commercializing innovative monoclonal antibody therapies, particularly in oncology. Its flagship anti-PD-1 product serplulimab is already approved across multiple cancer indications in mainland China, the European Union and several Asian markets, with a strategic licensing partnership in Europe and India.

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Technical Sentiment Signal: Strong Buy

Current Market Cap: HK$38.67B

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