HanchorBio Wins FDA IND Clearance for Trispecific Drug HCB303
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Taipei, Shanghai and San Francisco – October 05, 2026 -- HanchorBio, Inc. (TWSE: 7827) said the U.S. Food and Drug Administration has cleared the investigational new drug application for HCB303, clearing the path for the company's second trispecific immunotherapy to enter human testing.
FDA clearance unlocks Phase 1 trial for advanced solid tumors
The clearance allows HanchorBio to launch a Phase 1 first-in-human, dose-escalation, multi-regional study (HCB303-ONC-101) in patients with advanced, relapsed or refractory solid tumors who have exhausted standard treatment options. The trial will assess safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, biomarkers and preliminary antitumor activity. The decision follows pre-IND feedback HanchorBio received from the FDA in August 2026.