On September 9, 2026 HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developing next-generation immunotherapies for oncology and immune-mediated diseases, reported that the U.S. Food and Drug Administration (FDA) has cleared its HCB101 Single-Patient Expanded Access Protocol (HCB101- EA-001) as "safe to proceed".
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The FDA determination enables a patient who experienced clinical benefit while receiving HCB101 in the Company’s Phase 1 study to continue treatment with HCB101 beyond the parent clinical trial. Expanded Access, or compassionate use, allows patients with serious or life-threatening diseases to receive investigational therapies outside standard clinical trials when specific regulatory criteria are met. In an individual-patient Expanded Access request, FDA considers the patient’s clinical circumstances, including whether the potential benefit justifies the potential risks and whether those risks are reasonable in the context of the disease.
"For us, this starts with the patient," said Scott Liu, Ph.D., Founder and Chairman of HanchorBio. "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. HCB101 was created to make a meaningful difference, and this milestone reflects the patient-first principle guiding our FBDB platform."
FDA’s determination that HCB101-EA-001 is "safe to proceed" applies specifically to this individual-patient Expanded Access protocol and does not constitute approval of HCB101 or an FDA determination of efficacy.
"Working within the FDA framework, we translated an individual patient’s need into a practical solution allowing treatment to continue," said Alvin Luk, Ph.D., M.B.A., President and Chief Medical Officer (Group) and Chief Executive Officer (USA) of HanchorBio. "That is where clinical medicine, regulatory science, and drug development properly align."
A Potential First for the SIRPα-Fc Fusion Protein Class
While Expanded Access pathways have previously been utilized for the anti-CD47 monoclonal antibody, HCB101-EA-001 is clinically and structurally distinct:
Targeted Continuation: Unlike broad population access programs, HCB101-EA-001 was specifically established to extend treatment for an individual patient who determined clinical benefit during a Phase 1 clinical trial.
Novel Mechanism: HCB101 is an engineered SIRPα-Fc fusion protein designed to block the CD47-SIRPα "don’t eat me" signal and trigger macrophage-mediated tumor-cell phagocytosis.
Based on publicly available information, HanchorBio believes this is the first reported U.S. Expanded Access case for a SIRPα-Fc fusion protein, setting a significant precedent as HanchorBio continues to advance the program globally across multiple tumor types and combination strategies.
About HCB101
HCB101 is an investigational engineered SIRPα–IgG4 Fc fusion protein developed using HanchorBio’s FBDB platform. HCB101 blocks CD47–SIRPα signaling to restore macrophage-mediated antitumor immunity and downstream de novo T-cell activation. It is being evaluated as monotherapy (NCT05892718) and in combination (NCT06771622) across solid and hematologic malignancies and holds U.S. FDA Orphan Drug Designation for gastric cancer.
(Press release, Hanchor Bio, SEP 9, 2026, View Source [SID1234670690])