Henlius (02696.HK): HLX316 (B7-H3-Targeting Sialidase Fc Fusion Protein) Completes First Patient Dosing in Phase I Trial
NewTimeSpace News: Shanghai Henlius Biotech, Inc. (02696.HK) announced that the first patient has been dosed in the Phase I clinical research of self-developed injectable HLX316, a B7-H3-targeting sialidase Fc fusion protein, for advanced and metastatic solid tumors in China. As an innovative first-in-class B7-H3-targeting sialidase heterodimer, no equivalent product has obtained marketing approval globally.
NewTimeSpace News: Shanghai Henlius Biotech, Inc. (02696.HK) released a voluntary announcement on May 22, 2026, stating that HLX316 has finished the first patient administration in Phase I clinical trial.
This open-label first-in-human Phase I study aims to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of HLX316 among patients suffering from advanced and metastatic solid tumors. The trial includes Phase Ia dose escalation and backfill stage as well as Phase Ib dose expansion stage. Five dose levels ranging from 1.0 mg/kg to 30.0 mg/kg will be applied once a week in Phase Ia. The primary goals are to assess safety and tolerability, and confirm maximum tolerated dose and recommended dose for Phase II study.
HLX316 is developed by combining B7-H3-targeting variable domain of heavy chain-only antibody and authorized bifunctional sialidase fusion protein. The novel first-in-class heterodimer consists of engineered human sialidase Neu2 fused with human IgG1 Fc segment, and B7-H3-specific binding VHH fused with human IgG1 Fc segment. It targets B7-H3-positive tumors, blocks immune checkpoint via enzymatically splitting immunosuppressive sialylated glycans and boosts anti-tumor immune reaction.
Preclinical tests verify that HLX316 delivers strong antigen-oriented desialylation effect on tumor cells in vitro and restrains tumor growth in humanized mouse models. Up to the announcement date, no B7-H3-targeting sialidase Fc fusion protein has been approved for sale across the world.
NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.
Tags：
- Henlius (02696.HK): HLX48 (EGFR/c-MET Dual-target ADC) Secures Australian Approval for Phase I Clinical Trial
- Henlius (02696.HK): HLX97 (KAT6A/B Inhibitor) Completes First Patient Dosing in Phase I Clinical Trial for Advanced Solid Tumors
- Henlius (02696.HK): Self-Developed KAT6A/B Inhibitor HLX97 Approved for Clinical Trial
- HENLIUS(02696.HK): Enters into License Agreement with Eisai, Authorizing Commercialization of Hansoh® for Oncology Indications in Japan
- HENLIUS(02696.HK): Completes H-Share Full Circulation, 182.65 Million Unlisted Shares Converted to H-Shares to List Tomorrow
