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.
HCB303 targets CD226 downregulation that conventional anti-TIGIT antibodies leave open
Several late-stage anti-TIGIT antibody trials have produced disappointing results. HanchorBio's design responds to one proposed limitation. TIGIT and the activating receptor CD226 share the ligands PVR/CD155 and CD112. Conventional antibodies block TIGIT but do not stop those ligands from engaging CD226, and sustained CD155 engagement can drive CD226 internalization and downregulation.
HCB303's TIGIT-Fc ligand trap is built to bind the shared ligands and potentially preserve CD226 surface expression. The molecule also combines PD-L1 blockade with SIRPα-mediated CD47 checkpoint inhibition, aiming to coordinate macrophage, T-cell and NK-cell responses in a single trispecific protein.
HanchorBio says it remains to be established whether preserving CD226 expression supports immune-activating signaling and translates into antitumor activity and clinical benefit.
Phase 1 study HCB303-ONC-101 will enroll patients with advanced solid tumors
The first-in-human, dose-escalation trial (NCT07859228) will enroll patients with advanced, relapsed or refractory solid tumors who have exhausted appropriate standard options. Endpoints include safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers and preliminary antitumor activity. Translational work will track CD226 expression, TIGIT-associated ligands and myeloid immune cells to test whether the design produces its intended effects in patients.
Alvin Luk, President and Chief Medical Officer (Group) and CEO (USA), said that "a compelling story does not automatically translate into clinical benefit," and that the study's evidence will determine the next development decisions. Trial initiation and enrollment remain subject to regulatory requirements, institutional ethics approval and clinical site readiness.
HCB303 is the second FBDB platform trispecific headed for human trials
HCB303 follows HCB301 as the second trispecific immunotherapy from HanchorBio's FBDB platform to advance toward human evaluation. HCB301 integrates SIRPα, PD-L1 and TGF-β biology, while HCB303 pairs the TIGIT-Fc ligand trap with SIRPα and PD-L1 modulation.
The company notes that FDA clearance and TFDA approval authorize clinical investigation only. They are not marketing approvals and do not establish the safety or efficacy of HCB303.