复星医药(02196.HK):HLX701联合西妥昔单抗和化疗治疗晚期结直肠癌的1b/2期临床试验申请获国家药监局批准
Ge Long Hui·2026-01-20 09:21

Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received approval from the National Medical Products Administration to conduct Phase Ib/II clinical trials for HLX701 in combination with Cetuximab and chemotherapy for advanced colorectal cancer [1] Group 1: Clinical Trial Approval - The approval allows for the clinical trials of HLX701 to be conducted in mainland China, excluding Hong Kong, Macau, and Taiwan [1] - HLX701 is a recombinant human SIRPα-IgG4 Fc fusion protein injection [1] Group 2: Licensing and Development - HLX701 was licensed from FBD Biologics Limited in June 2025, granting exclusive rights for development, production, and commercialization in specified regions including mainland China, Hong Kong, Macau, Southeast Asia, the Middle East, and North Africa [1] - As of December 2025, the cumulative R&D investment for HLX701 by the group is approximately RMB 76.09 million, which includes licensing fees [1] Group 3: Market Context - As of the announcement date, there are no approved targeted CD47 SIRPα-Fc fusion proteins available globally [1]