HanchorBio Receives FDA Orphan Drug Designation for HCB101 in Gastric Cancer
Tuesday, February 17, 2026
HanchorBio, Inc. has received Orphan Drug Designation from the U.S. Food and Drug Administration for HCB101 to treat gastric cancer. The designation applies to gastric cancer broadly, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients.
This is the company’s first Orphan Drug Designation from the FDA and marks an important regulatory step. It supports the continued clinical development of HCB101 in an area where treatment options remain limited.
HCB101 is a next-generation inhibitor targeting the CD47–SIRPα pathway. It has been designed as an affinity-optimised and toxicity-reduced SIRPα-IgG4 Fc fusion protein. The treatment aims to restore macrophage-driven phagocytosis and improve antigen presentation, while lowering the blood-related side effects that have affected earlier CD47-targeted therapies. This approach also allows it to be combined with standard cancer treatments.
Gastric cancer is considered a rare disease in the United States under FDA criteria for orphan status. Despite progress in targeted therapies and immune checkpoint inhibitors, patient outcomes remain poor, especially in second-line treatment. Responses are often short-lived and side effects can be significant.
HCB101 is currently being studied in several clinical trials, including a Phase 1b/2a study (NCT06771622). This trial is evaluating HCB101 in combination with ramucirumab and paclitaxel for second-line advanced gastric cancer. Early results have shown encouraging anti-tumour activity and a safety profile in line with its design.
Orphan Drug Designation provides development benefits such as tax credits for eligible clinical trial costs, exemption from certain FDA fees, and up to seven years of market exclusivity in the United States if the treatment is approved.
HanchorBio plans to continue the global clinical development of HCB101 and assess its potential use across multiple solid tumour types and blood cancers. The therapy has been developed using the company’s FBDB™ platform and AI-supported structural modelling to improve selective binding to cancer cells while reducing interaction with red blood cells.
Ongoing clinical and translational studies indicate consistent target engagement and early signs of anti-tumour activity, both as a standalone therapy and in combination with other treatments. These features position HCB101 as a potential backbone immunotherapy for combination strategies across a range of cancers.
Source: prnewswire.com
