Meet Samuel – Your Personal Investing Prophet
- Start a conversation with TipRanks’ trusted, data-backed investment intelligence
- Ask Samuel about stocks, your portfolio, or the market and get instant, personalized insights in seconds
Shanghai Henlius Biotech, Inc. Class H ( (HK:2696) ) has issued an update.
Shanghai Henlius Biotech announced that its serplulimab injection, branded as HANSIZHUANG in China and HETRONIFLY in the European Union, has received positive opinions from the EMA’s Committee for Medicinal Products for Human Use. The panel recommended approval for its use with chemotherapy as a first-line treatment for adults with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma, and for adults with locally advanced or metastatic non-squamous non-small cell lung carcinoma.
The recommendation is based on two phase 3 trials in which serplulimab plus chemotherapy showed significant efficacy and good safety versus chemotherapy alone in both cancer settings, and follows EU GMP certification of the drug’s production lines in the Netherlands. If the European Commission confirms the opinion, Henlius will gain centralized marketing authorization across the EU and EEA, bolstering its international oncology footprint alongside existing approvals in China, the EU for small cell lung cancer, and several Asian and other markets, as well as its out-licensing deal with Intas for Europe and India.
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 lead product, the anti-PD-1 antibody serplulimab (marketed as HANSIZHUANG in China and HETRONIFLY in the EU), targets cancers such as lung and esophageal cancers and is being rolled out across global markets including Europe and Asia.
Average Trading Volume: 980,458
Technical Sentiment Signal: Buy
Current Market Cap: HK$25.95B
For a thorough assessment of 2696 stock, go to TipRanks’ Stock Analysis page.