Zhi Tong Cai Jing·2025-12-12 09:47Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received acceptance from the National Medical Products Administration for a new indication of its drug, Surulitinib Injection, which is now included in the priority review process [1][2] Group 1 - The drug is an innovative anti-PD-1 monoclonal antibody developed by the group [2] - As of December 12, 2025, the drug has been approved for marketing in multiple countries, including China, the EU, the UK, and India, with various indications [2] - Current approved indications in China include first-line treatment for squamous non-small cell lung cancer, extensive small cell lung cancer, esophageal squamous cell carcinoma, and non-squamous non-small cell lung cancer [2] Group 2 - The drug has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [2] - The indication for combined chemotherapy in gastric cancer has been included in the breakthrough therapy program by the National Medical Products Administration as of November 2025 [2] - Multiple clinical trials involving the drug are ongoing globally, targeting various cancers such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [2]