Core Viewpoint - The approval of the IND application for HLX701 in combination with cetuximab and chemotherapy for the treatment of advanced colorectal cancer marks a significant advancement for the company in its clinical development pipeline [1][2]. Group 1: Product Overview - HLX701 is a SIRPα-Fc fusion protein licensed from FBD Biologics Limited, intended for the treatment of various advanced solid tumors [2]. - The company holds exclusive rights for the development, production, and commercialization of HLX701 in China (excluding Taiwan), Southeast Asia, the Middle East, and North Africa [2]. Group 2: Mechanism of Action - HLX701 functions by binding to CD47 on tumor cells, effectively blocking the inhibitory CD47 anti-phagocytic signal, which promotes macrophage phagocytosis of tumor cells and enhances anti-tumor activity [2]. - Preclinical studies indicate that HLX701 can synergize with various drugs, including chemotherapy agents, immune checkpoint inhibitors, epidermal growth factor receptor inhibitors, and anti-angiogenic drugs, suggesting potential for enhanced innate and adaptive immune responses when used in combination with standard treatment regimens [2].
复宏汉霖(02696)：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NMPA批准