Taipei – September 12, 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.
Company claims first U.S. Expanded Access case for a SIRPα-Fc fusion protein
HanchorBio said HCB101-EA-001 is, based on publicly available information, the first reported U.S. Expanded Access case for a SIRPα-Fc fusion protein, distinguishing it from prior Expanded Access use involving anti-CD47 monoclonal antibodies. HCB101 is an engineered SIRPα-IgG4 Fc fusion protein built on the company's FBDB platform, designed to block the CD47-SIRPα "don't eat me" signal and trigger macrophage-mediated destruction of tumor cells.
"When a patient is benefiting from an investigational therapy and has limited treatment options, we believe every appropriate avenue to continue access should be considered," said Scott Liu, Ph.D., Founder and Chairman of HanchorBio.
HCB101 program spans monotherapy and combination trials with orphan drug status
HCB101 is currently being evaluated as a monotherapy (NCT05892718) and in combination with other agents (NCT06771622) across solid tumors and hematologic malignancies. The compound holds U.S. FDA Orphan Drug Designation for gastric cancer. HanchorBio said it plans to advance the HCB101 program globally across additional tumor types and combination strategies.