Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., has received breakthrough therapy designation for its independently developed Sru Li Anti-Inflammatory Injection for use in combination chemotherapy for gastric cancer [1] Company Summary - The drug is an innovative anti-PD-1 monoclonal antibody developed by Fosun Pharma [1] - As of November 20, 2025, the drug has been approved for marketing in multiple countries, including China, the EU, the UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India [1] - 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) [1] - The drug has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [1] - Multiple combination therapies involving this drug are currently undergoing clinical trials in various countries, targeting indications such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma, colorectal cancer, and gastric cancer [1]

此外，公司正有序推进汉斯状及相关联合疗法在全球开展的多项临床试验，广泛覆盖肺癌、食管癌、头 颈鳞癌、结直肠癌和胃癌等适应症。 复宏汉霖(02696)发布公告，近日，汉斯状(斯鲁利单抗注射液)联合化疗新辅助/辅助治疗胃癌获国家药 品监督管理局(NMPA)药品审评中心(CDE)正式纳入突破性治疗药物程序。 汉斯状为公司自主开发的创新型抗PD-1单抗，其于中国内地已获批上市的适应症包括联合化疗一线治 疗鳞状非小细胞肺癌(sq-NSCLC)、广泛期小细胞肺癌(ES-SCLC)、食管鳞状细胞癌(ESCC)及非鳞状非小 细胞肺癌(nsq-NSCLC)。同时，汉斯状亦已分别于欧盟、英国、印度尼西亚、柬埔寨、泰国、马来西 亚、新加坡及印度等国家/地区获批上市，并分别获美国、欧盟、瑞士及韩国等国家/地区的药品监督管 理部门授予孤儿药资格认定。 ...

Group 1 - The core point of the news is that the clinical trial for the company's self-developed drug, Hanshuai (Sru Li Antibody Injection), has met the primary endpoint of event-free survival (EFS) in a mid-term analysis, supporting an early application for market approval [1] - The study is a randomized, double-blind, multi-center Phase 3 clinical trial comparing the efficacy and safety of Hanshuai combined with chemotherapy against placebo combined with chemotherapy for early gastric cancer patients [1] - The independent data monitoring committee (IDMC) found that Hanshuai combined with chemotherapy showed a significant improvement in EFS compared to the control group, with a pathological complete response (pCR) rate more than three times that of the control group, and a significant reduction in recurrence risk, while safety was good with no new safety signals identified [1] Group 2 - Hanshuai is an innovative anti-PD-1 monoclonal antibody developed by the company, which has been approved for several indications in mainland China, including 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] - The drug has also been approved in various countries/regions including the EU, UK, Indonesia, Cambodia, Thailand, Malaysia, Singapore, and India, and has received orphan drug designation from regulatory authorities in the US, EU, Switzerland, and South Korea [2] Group 3 - The company is actively advancing multiple clinical trials for Hanshuai and related combination therapies globally, covering a wide range of indications including lung cancer, esophageal cancer, head and neck squamous cancer, colorectal cancer, and gastric cancer [3]

格隆汇10月9日丨复宏汉霖(02696.HK)宣布，近日，一项比较公司自主开发的汉斯状®(斯鲁利单抗注射 液)("汉斯状®")或安慰剂联合化疗(奥沙利铂+替吉奥)新辅助/辅助治疗胃癌的3期临床研究在计划的期中 分析中，经独立数据监查委员会(Independent Data Monitoring Committee，"IDMC")评估达到了无事件生 存期(EFS)的主要研究终点，可支持提前申报上市。 汉斯状®为公司自主开发的创新型抗PD-1单抗，其于中国境内(不包括中国港澳台地区，下同)已获批上 市的适应症包括联合化疗一线治疗鳞状非小细胞肺癌(sq-NSCLC)，广泛期小细胞肺癌(ES-SCLC)、食管 鳞状细胞癌(ESCC)及非鳞状非小细胞肺癌(nsq-NSCLC)。同时，汉斯状®亦已分别于欧盟、英国、印度 尼西亚、柬埔寨、泰国、马来西亚、新加坡、及印度等国家/地区获批上市，并分别获美国、欧盟、瑞 士及韩国等国家/地区的药品监督管理部门授予孤儿药资格认定(Orphan-drug Designation)。 此外，公司正有序推进汉斯状®及相关联合疗法在全球开展的多项临床试验，广泛覆盖肺癌、食管癌、 头颈鳞癌、结 ...