Group 1 - The company Fuhong Hanlin (02696) has received approval from the National Medical Products Administration (NMPA) for a clinical trial application involving HLX43, a PD-L1 targeted antibody-drug conjugate, in combination with HLX07 and Hanshuan® for the treatment of advanced solid tumors [1] - HLX43's phase 1 clinical data is set to be presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting and the 2025 World Lung Cancer Conference (WCLC), showing promising safety and preliminary efficacy in non-small cell lung cancer (NSCLC) and other solid tumors [2] - HLX07, an innovative biopharmaceutical developed by the company targeting the EGFR pathway, has demonstrated good safety and tolerability in a phase 1b/2 clinical study for advanced solid tumors [2] - Hanshuan® (sruvalizumab) has been approved for multiple indications in mainland China, including first-line treatment for squamous NSCLC, extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous NSCLC [2] - The New Drug Application (NDA) for Hanshuan® in combination with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer has been accepted by the NMPA and is included in the priority review process [2]
复宏汉霖(02696)：注射用HLX43联合HLX07及汉斯状 用于晚期实体瘤治疗的临床试验申请获国家药品监督管理局批准