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Shanghai Henlius Biotech’s HLX11 BLA Accepted by FDA

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Shanghai Henlius Biotech’s HLX11 BLA Accepted by FDA

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

Shanghai Henlius Biotech, Inc. announced that its biologics license application for HLX11, a biosimilar to Perjeta® (pertuzumab), has been accepted by the U.S. FDA. The acceptance positions the company to expand its market reach in the U.S. for treatments of HER2-positive breast cancer. This development follows successful phase 3 clinical trials and a global commercialization agreement with Organon, underscoring the company’s strategic growth in the oncology sector.

More about Shanghai Henlius Biotech, Inc. Class H

Shanghai Henlius Biotech, Inc. is a biotechnology company based in the People’s Republic of China, focused on the development and commercialization of biosimilars. The company specializes in biologics, with a market focus on treatments for various types of cancer, including breast cancer.

YTD Price Performance: -29.28%

Average Trading Volume: 675,461

Technical Sentiment Consensus Rating: Buy

Current Market Cap: HK$9.11B

For detailed information about 2696 stock, go to TipRanks’ Stock Analysis page.

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