智通财经网·2025-12-12 09:49Core 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 aimed at treating PD-L1 positive, resectable gastric cancer patients in combination with platinum-based chemotherapy [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, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [2] - Approved indications in China include 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) [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 combination chemotherapy in gastric cancer was included in the breakthrough therapy program by the National Medical Products Administration in November 2025 [2] - Multiple clinical trials involving the drug are ongoing globally, targeting various cancers including lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [2]