Ge Long Hui·2025-11-20 10:13Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received inclusion of its independently developed drug, Surulitinib Injection, in the breakthrough therapy program for the treatment of gastric cancer in China [1][2] Group 1: Drug Development and Approval - Surulitinib is an innovative anti-PD-1 monoclonal antibody developed by the group [2] - As of November 20, 2025, the drug has been approved for marketing in multiple countries/regions including China, the EU, the UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [2] - In China, the approved indications 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) [2] 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 [2] - Multiple combination therapies involving Surulitinib 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 [2]