Henlius (02696): NMPA Approves IND for First-in-Class B7-H3-Targeting Sialidase Fusion Protein HLX316 in Advanced Solid Tumours

Bulletin Express03-09

Shanghai Henlius Biotech, Inc. (Stock Code: 02696; “Henlius”) has obtained National Medical Products Administration clearance for a Phase I investigational new drug (IND) study of HLX316, a B7-H3-targeting sialidase Fc fusion protein, in patients with advanced or metastatic solid tumours.

HLX316 combines Henlius’ proprietary heavy-chain-only antibody variable domain (VHH) that binds B7-H3 with an engineered human sialidase Neu2 fused to an IgG1 Fc region, a technology licensed from Palleon Pharmaceuticals Inc. in May 2024. By enzymatically removing immunosuppressive sialylated glycans on tumour cells, the molecule is designed to deliver immune checkpoint blockade and enhance anti-tumour responses without systemic activation.

Pre-clinical data show potent antigen-directed desialylation, tumour growth inhibition in humanised mouse models and potential therapeutic benefit for advanced solid tumours. Currently, no B7-H3-targeting sialidase Fc fusion protein has received marketing approval worldwide, positioning HLX316 as a potential first-in-class therapy if successfully developed and commercialised.

Henlius reiterates that development outcomes and commercialisation timelines remain uncertain, and investors should exercise caution when dealing in the company’s shares.

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