智通财经网·2025-10-17 12:06Core 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 subsequent research, registration, and commercialization in the U.S. by providing certain policy supports [1] - Benefits of the designation include tax credits for clinical trial costs, exemption from new drug application fees, and seven years of market exclusivity unaffected by patent status [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 associated with the orphan drug status [1]