Henlius Wins FDA Acceptance of BLA for Bevacizumab Biosimilar HANBEITAI

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

Shanghai Henlius Biotech has announced that the US Food and Drug Administration has accepted its biologics license application for HANBEITAI, a bevacizumab injection developed in-house, for use across six cancer indications including metastatic colorectal cancer, various forms of lung, brain, kidney, ovarian and cervical cancers. The application is supported by analytical and pharmacokinetic similarity data versus the reference bevacizumab product, and comes after HANBEITAI’s earlier approvals for multiple oncology indications in mainland China, positioning Henlius to potentially enter the US$5.25 billion global bevacizumab market and further expand its international presence if the product ultimately secures US market approval.

The most recent analyst rating on (HK:2696) stock is a Hold with a HK$74.00 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 the independent development and commercialization of biosimilar and innovative monoclonal antibody therapies, with a product portfolio that includes oncology biologics such as bevacizumab for multiple solid tumor indications and a growing international market focus beyond the Chinese mainland.

Average Trading Volume: 1,053,806

Technical Sentiment Signal: Buy

Current Market Cap: HK$36.41B

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