Henlius Wins NMPA Nod to Launch First-in-Class HLX316 Cancer Trial

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

Shanghai Henlius Biotech has obtained approval from China’s National Medical Products Administration to begin a phase 1 clinical trial of HLX316, an investigational B7-H3-targeting sialidase Fc fusion protein for patients with advanced or metastatic solid tumours. The drug candidate, developed using Henlius’ proprietary heavy-chain-only antibody variable domain and a sialidase fusion technology licensed from Palleon Pharmaceuticals, aims to boost anti-tumour immune responses by selectively cleaving immunosuppressive glycans on B7-H3-expressing tumours.

Pre-clinical data indicate that HLX316 can inhibit tumour growth and drive potent antigen-directed desialylation in vitro and in humanized mouse models, suggesting potential therapeutic benefits in advanced solid cancers. With no B7-H3-targeting sialidase Fc fusion protein yet approved anywhere globally, the NMPA’s IND clearance positions Henlius at the forefront of this emerging modality, while the company cautions that successful development and commercialization are not guaranteed and remain subject to clinical outcomes.

The most recent analyst rating on (HK:2696) stock is a Hold with a HK$64.00 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 Chinese biopharmaceutical company focused on developing innovative biologic therapies, including antibody-based drugs for oncology. Listed in Hong Kong, it leverages proprietary antibody technologies and partnerships to expand its pipeline targeting advanced and metastatic cancers.

Average Trading Volume: 954,765

Technical Sentiment Signal: Strong Buy

Current Market Cap: HK$24.97B

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