China Approves Phase 1 Trial of Henlius' B7-H3-Targeting Cancer Therapy HLX316
Shanghai Henlius Biotech received approval from China's National Medical Products Administration to begin a phase 1 clinical trial of HLX316, a B7-H3-targeting sialidase Fc fusion protein for advanced or metastatic solid tumors.
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 was developed using Henlius' proprietary heavy-chain-only antibody variable domain and a sialidase fusion technology licensed from Palleon Pharmaceuticals. HLX316 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. The company cautions that successful development and commercialization are not guaranteed and remain subject to clinical outcomes.