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复星医药:控股子公司药品纳入突破性治疗药物程序 全球范围内尚无靶向PD-1的单克隆抗体药品获批用于胃癌新辅助/辅助治疗
Mei Ri Jing Ji Xin Wen·2025-11-20 08:56

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received breakthrough therapy designation for its independently developed drug, Surulitinib injection, for use in combination with chemotherapy for gastric cancer treatment [1] Group 1: Drug Approval and Indications - Surulitinib injection has been approved for use in China, the EU, and the UK, with indications including 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 [1] - The drug is an innovative anti-PD-1 monoclonal antibody developed by the company and its subsidiaries [1] Group 2: Market Position - As of the announcement date, there are no approved targeted PD-1 monoclonal antibody drugs for neoadjuvant/adjuvant treatment of gastric cancer globally [1]