HanchorBio, a global clinical-stage biotechnology company advancing next-generation immunotherapies, has announced that the US FDA has granted Orphan Drug Designation (ODD) to its experimental therapy for the treatment of gastric cancer.
The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients.
This marks a major regulatory milestone for HanchorBio—the company’s first FDA ODD—highlighting the critical unmet need in gastric cancer and reinforcing HanchorBio’s strategy of developing differentiated immunotherapies for challenging diseases.
HCB101 is a next-generation CD47–SIRPα pathway inhibitor, engineered as an affinity-optimized and toxicity-mitigated SIRPα-IgG4 Fc fusion protein. The therapy is designed to restore macrophage-mediated phagocytosis and enhance antigen presentation, while reducing the blood-related toxicities that have historically limited CD47-targeted therapies.
"Receiving our first FDA Orphan Drug Designation is a major milestone for HanchorBio and important validation of our scientific, regulatory, and development strategy," said Scott Liu, Founder, Chairman, and CEO of HanchorBio.
"Gastric cancer remains an area of profound unmet medical need, and this designation reinforces our commitment to developing differentiated immunotherapies that can meaningfully improve outcomes for patients. This designation strengthens HCB101's profile as a globally relevant asset and represents a strategically important step as we advance the program toward U.S. and international development. It further supports our ongoing engagement with multinational partners as we explore collaboration and licensing opportunities for HCB101 and our broader immunotherapy pipeline."
Gastric cancer is rare in the US, with prevalence well below the FDA threshold for orphan designation. Despite advances in targeted therapy and immune checkpoint inhibition, outcomes—especially in second-line treatment—remain poor, with limited durability and high toxicity.
"The FDA's decision reflects the seriousness of gastric cancer and the clinical rationale underlying HCB101's development," said Alvin Luk, President & Chief Medical Officer (Group) and CEO (U.S.A.) of HanchorBio.
"HCB101's IgG4-based SIRPα-Fc design was intentionally selected to support repeated dosing and combination strategies as an innate immune checkpoint backbone in solid tumors. In a second-line gastric cancer setting, where standard regimens offer limited durability, the depth of tumor shrinkage and consistency of response observed to date, while remaining compatible with standard ramucirumab-paclitaxel administration, support the continued global advancement of HCB101 for patients with significant unmet need."
