Core Viewpoint - The company has received approval from the National Medical Products Administration (NMPA) for the clinical trial application of HLX701 in combination with cetuximab and chemotherapy for the treatment of advanced colorectal cancer, indicating a significant step forward in its clinical development pipeline [1] Group 1: Product Development - HLX701 is a recombinant SIRPα-IgG4Fc fusion protein licensed from FBD Biologics Limited, intended for the treatment of various advanced solid tumors [1] - 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 [1] Group 2: Mechanism of Action - HLX701 works 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 [1] - 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 immune responses when used in combination with standard treatment regimens [1]
复宏汉霖：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