HanchorBio

TAIPEI – October 30, 2026 -- HanchorBio (TWSE: 7827) has received Taiwan Food and Drug Administration approval for the Investigational New Drug application for HCB303, its trispecific TIGIT-Fc ligand-trap fusion protein, following U.S. FDA clearance. The approval was granted to its wholly owned subsidiary, FBD Biologics Limited, and gives the asset regulatory authorization for clinical investigation in two jurisdictions.

TFDA used a 15-day accelerated pathway for multinational trials

HCB303 cleared through Taiwan's accelerated review route for multinational, multicenter clinical trials, which provides a 15-day review for eligible applications. TFDA has also simplified submission requirements for qualifying first-in-human studies. Under applicable conditions, sponsors no longer need to submit institutional review board approval letters from foreign participating hospitals.