HanchorBio Inc (TPEx:7827), a global clinical-stage biotechnology company based in Taiwan, announced on Friday that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for HCB101 for the treatment of gastric cancer.

The designation covers gastric cancer broadly, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative subtypes. It provides regulatory support for the continued clinical development of HCB101 in this patient population.

HCB101 is a next-generation CD47–SIRP alpha pathway inhibitor, engineered as an affinity-optimised and toxicity-mitigated SIRP alpha-IgG4 Fc fusion protein. The molecule is designed to restore macrophage-mediated phagocytosis and enhance antigen presentation while minimising the hematologic toxicities that have historically limited earlier CD47-targeting approaches, enabling rational combination with established standards of care.

HCB101 is currently being evaluated in multiple ongoing clinical studies, including a Phase 1b/2a trial of HCB101 in combination with ramucirumab and paclitaxel in second-line advanced gastric cancer.