Hanchor Bio announced that the U.S. FDA has granted Orphan Drug Designation (ODD) to its lead candidate, HCB101, for the treatment of Gastric Cancer, including advanced gastric adenocarcinoma.

• Technical Platform: HCB101 is an innovative fusion protein developed via Hanchor’s proprietary FBDB (Fc-Based Designer Biologics) platform. It is currently in Phase 2a trials for multiple indications, including gastric, triple-negative breast, head and neck, and colorectal cancers.
• Clinical Signals: Preliminary data for HCB101 in combination with Ramucirumab and Paclitaxel (second-line gastric cancer) demonstrated favorable safety and a potentially clinically meaningful Objective Response Rate (ORR) compared to historical standard-of-care (SOC) data.
• Regulatory Advantages: Under the Orphan Drug Act, Hanchor will benefit from tax credits for clinical trials, waiver of FDA application fees, and, most importantly, seven years of market exclusivity in the U.S. upon approval. Gastric cancer remains a high-mortality disease with significant unmet medical needs in the U.S., where the prevalence is below the 200,000-person threshold for ODD status.

Resource: 漢康開發中新藥HCB101 獲美國FDA授予治胃癌之孤兒藥資格認定