Core Viewpoint - The announcement highlights the inclusion of Hanshuo (Sruilumab injection) in the National Medical Products Administration (NMPA) breakthrough therapy program for the neoadjuvant/adjuvant treatment of gastric cancer, indicating a significant advancement for the company in the oncology sector [1] Group 1: Product Development - Hanshuo is an innovative anti-PD-1 monoclonal antibody developed by the company, which has already been approved for various indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive-stage small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [1] - The product has also received approvals in multiple countries/regions, including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has been granted orphan drug designation by regulatory authorities in the US, EU, Switzerland, and South Korea [1] Group 2: Clinical Trials - The company is actively advancing multiple clinical trials for Hanshuo and related combination therapies globally, covering a wide range of indications such as lung cancer, esophageal cancer, head and neck squamous cancer, colorectal cancer, and gastric cancer [1]
复宏汉霖：汉斯状 (斯鲁利单抗注射液)联合化疗用于胃癌新辅助/辅助治疗获国家药品监督管理局药品审评中心正式纳入突破性治疗药物程序