FDA Clears HanchorBio's HCB101 Single-Patient Expanded Access Protocol, a First for SIRPα-Fc Fusion Proteins
核心洞察
The FDA has cleared HanchorBio (搜索)'s HCB101 Single-Patient Expanded Access Protocol (HCB101-EA-001) as "safe to proceed," allowing continued dosing beyond the parent Phase 1 study.
The protocol extends HCB101 treatment for one patient who experienced clinical benefit in the Phase 1 trial and has limited remaining treatment options.
HanchorBio (搜索) believes HCB101-EA-001 is the first reported U.S. Expanded Access case for a SIRPα (搜索)-Fc fusion protein, distinct from prior anti-CD47 (搜索) antibody programs.
The U.S. Food and Drug Administration has cleared HanchorBio (搜索)'s HCB101 Single-Patient Expanded Access Protocol (HCB101-EA-001) as "safe to proceed," enabling a patient who experienced clinical benefit during the company's Phase 1 study to continue receiving the investigational therapy beyond the parent trial.
HanchorBio (搜索), a clinical-stage biotechnology company listed on the Taiwan Stock Exchange (TWSE: 7827), announced the determination on Sept. 9, 2026. Expanded Access, also known as compassionate use, permits 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 request, the FDA weighs 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 (搜索). "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."
Alvin Luk, Ph.D., M.B.A., President and Chief Medical Officer (Group) and Chief Executive Officer (USA) of HanchorBio (搜索), framed the clearance as an alignment of clinical and regulatory priorities: "Working within the FDA framework, we translated an individual patient's need into a practical solution allowing treatment to continue. That is where clinical medicine, regulatory science, and drug development properly align."
The company emphasized that the FDA's "safe to proceed" determination applies specifically to this individual-patient Expanded Access protocol and does not constitute approval of HCB101 or an FDA determination of efficacy.
A Distinctive Entry in the SIRPα-Fc Class
HanchorBio (搜索) describes HCB101-EA-001 as clinically and structurally distinct from earlier Expanded Access pathways, which have previously been utilized for the anti-CD47 (搜索) monoclonal antibody. The protocol was established specifically to extend treatment for an individual patient who demonstrated clinical benefit during a Phase 1 clinical trial, rather than to provide broad population access.
The mechanism underlying HCB101 differs from anti-CD47 (搜索) antibody approaches. HCB101 is an engineered SIRPα (搜索)-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 (搜索) believes this is the first reported U.S. Expanded Access case for a SIRPα (搜索)-Fc fusion protein — a precedent the company cites as it continues to advance the program globally across multiple tumor types and combination strategies.
HCB101 Program Details
HCB101 is an investigational engineered SIRPα (搜索)-IgG4 Fc fusion protein developed using HanchorBio (搜索)'s FBDB platform. According to the company, HCB101 blocks CD47 (搜索)-SIRPα signaling to restore macrophage-mediated antitumor immunity and downstream de novo T-cell activation.
The agent is being evaluated as monotherapy (NCT05892718) and in combination (NCT06771622) across solid and hematologic malignancies. It holds U.S. FDA Orphan Drug Designation for gastric cancer (搜索).
HanchorBio (搜索)'s broader pipeline includes clinical-stage programs HCB101 and HCB301, a next-generation trispecific program designated HCB303, and additional candidates spanning oncology and immune-mediated diseases.
HCB101 remains investigational and has not been approved for commercial use by the FDA or any other regulatory authority. The company noted that its announcement contains forward-looking statements regarding HCB101's clinical development, potential therapeutic benefits, regulatory interactions, and the significance of the Expanded Access protocol, which are subject to risks and uncertainties that could cause actual results to differ materially.