Core Viewpoint - The company has received official inclusion of its innovative anti-PD-1 monoclonal antibody, Hanshuo (Sru Li Single Antibody Injection), in the breakthrough therapy drug program by the National Medical Products Administration (NMPA) for the neoadjuvant/adjuvant treatment of gastric cancer [1] Group 1 - Hanshuo has been approved for multiple indications in mainland China, including first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), extensive small cell lung cancer (ES-SCLC), esophageal squamous cell carcinoma (ESCC), and non-squamous non-small cell lung cancer (nsq-NSCLC) [1] - The drug has also received approvals in various 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] - The company is actively advancing multiple clinical trials for Hanshuo and related combination therapies globally, covering a wide range of indications including lung cancer, esophageal cancer, head and neck squamous cancer, colorectal cancer, and gastric cancer [1]
复宏汉霖(02696)：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