Ge Long Hui·2025-12-12 11:51Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotech, has received acceptance for a new indication application for its drug, Surulitinib Injection, from the National Medical Products Administration of China, which has been included in the priority review process [1] Group 1: Drug Development and Approvals - Surulitinib Injection is an innovative anti-PD-1 monoclonal antibody developed by the company [1] - The drug has been approved for marketing in multiple countries/regions, including China, the EU, the UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [1] - Current approved indications in China include 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] Group 2: Regulatory Designations and Clinical Trials - The drug has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [1] - The indication for gastric cancer in combination with chemotherapy has been included in the breakthrough therapy program by the National Medical Products Administration of China as of November 2025 [1] - Multiple combination therapies involving this drug are currently undergoing clinical trials in various countries and regions, targeting indications such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [1]