复宏汉霖:注射用HLX43联合HLX07用于晚期/转移性实体瘤治疗的1b/2期临床试验申请获国家药监局批准

Core Viewpoint - The announcement highlights the approval of a clinical trial application for HLX43 in combination with HLX07 for the treatment of advanced/metastatic solid tumors by the National Medical Products Administration (NMPA) [1] Group 1: Product Development - HLX43 is a novel antibody-drug conjugate (ADC) targeting PD-L1, developed by the company using a licensed small molecule toxin-peptide linker and its own PD-L1 targeting antibody [1] - HLX07 is an innovative biological drug developed by the company targeting EGFR, intended for the treatment of advanced solid tumors [1] Group 2: Clinical Trials - The 1b/2 phase clinical study of HLX07 in combination with chemotherapy for advanced solid tumors showed good safety and tolerability as of February 2023 [1] - Multiple phase 2 clinical studies of HLX07 are currently underway in China, including trials for advanced cutaneous squamous cell carcinoma (CSCC) and advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) [1]