Zhi Tong Cai Jing·2025-10-17 12:09Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received Orphan-drug Designation from the FDA for its investigational drug HLX43, aimed at treating thymic epithelial tumors (TETs) [1] Group 1: FDA Orphan-drug Designation - The Orphan-drug Designation for HLX43 will facilitate its research, registration, and commercialization in the U.S. by providing various policy supports [1] - Benefits include tax credits for clinical trial costs, exemption from new drug application fees, and a seven-year market exclusivity without patent influence [1] Group 2: Market Considerations - If other drugs with the same indication are approved before HLX43, the company must demonstrate HLX43's superior efficacy in clinical settings to maintain the market exclusivity benefits [1]