复星医药子公司HLX701联合西妥昔单抗和化疗治疗晚期结直肠癌开展Ⅰb/Ⅱ期临床试验获国家药监局批准
Zhi Tong Cai Jing·2026-01-20 09:27

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 - HLX701 is a recombinant SIRPα-IgG4Fc fusion protein injection licensed from FBD Biologics Limited, with exclusive rights for development, production, and commercialization in China and certain regions [1] - The company plans to initiate clinical trials for HLX701 in mainland China, excluding Hong Kong, Macau, and Taiwan, once conditions are met [1] - As of December 2025, the cumulative R&D investment for HLX701 by the group is approximately RMB 76.09 million, including licensing fees [1] Group 2 - As of the announcement date (January 20, 2026), there are no approved targeted CD47 SIRPα-Fc fusion proteins available globally [1]