HanchorBio Inc.

HanchorBio Wins FDA IND Clearance for Trispecific Drug HCB303

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.

FDA Clears Expanded Access for HanchorBio's HCB101, a First for SIRPα-Fc Class

Taipei – September 13, 2026 -- HanchorBio Inc. (TWSE: 7827) said the U.S. Food and Drug Administration has cleared its HCB101 Single-Patient Expanded Access Protocol (HCB101-EA-001) as "safe to proceed," allowing a Phase 1 patient who showed clinical benefit to continue receiving the investigational drug beyond the parent trial.

FDA authorizes continued treatment for a single Phase 1 patient

The clearance permits the patient to keep receiving HCB101 outside the standard clinical trial structure under the FDA's Expanded Access, or compassionate use, framework. The agency's review weighed the patient's clinical circumstances, including whether the potential benefit justified the risks given the severity of the disease. HanchorBio noted the determination applies only to this individual-patient protocol and does not constitute approval of HCB101 or an FDA finding on its broader safety or efficacy.