本研究为一项在早期胃癌患者中开展的随机、双盲、多中心的3期临床研究，旨在比较汉斯状联合化疗 对比安慰剂联合化疗新辅助/辅助治疗早期胃癌患者的临床有效性及安全性。基于IDMC进行的预设期中 分析结果显示，汉斯状联合化疗对比安慰剂联合化疗显示出明显的无事件生存期(EFS)改善，达到预设 的优效性标准，病理完全缓解(pCR)率为对照组的3倍以上，患者复发风险显著降低，同时安全性良好， 未发现新的安全性信号。 复宏汉霖(02696)公布，近日，一项比较公司自主开发的汉斯状(斯鲁利单抗注射液)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。 ...

Core Insights - Amgen/Zai Lab announced the success of the Phase III clinical trial for Bemarituzumab, the first and only FGFR2b inhibitor demonstrating overall survival (OS) benefits in first-line treatment for gastric cancer, marking a significant breakthrough in the field [1][13]. Group 1: Development History of Gastric Cancer Drugs - Gastric cancer (GC) is a common and aggressive malignancy with high heterogeneity, ranking third in incidence and mortality among various cancers [1]. - The development of gastric cancer treatments has evolved through four stages: chemotherapy, targeted therapy, immunotherapy, and precision medicine [1][2][5]. - Early chemotherapy relied on 5-FU and platinum-based drugs, which had limitations such as limited efficacy and significant side effects [1]. Group 2: Targeted Therapies and Innovations - The targeted therapy era saw the emergence of several drugs, including Trastuzumab and Ramucirumab, which have changed treatment paradigms for HER2-positive gastric cancer [2][3]. - Despite advancements, targeted therapies face challenges such as limited patient populations and resistance issues [3]. - The immunotherapy era introduced PD-1/PD-L1 inhibitors, significantly impacting treatment options for advanced gastric cancer [5]. Group 3: Emerging Targets and Clinical Trials - Current innovative therapies target multiple biomarkers, including HER2, Claudin18.2, and FGFR2b, with ongoing clinical trials exploring their efficacy [7][12][13]. - The ADC drug targeting HER2, Trastuzumab Deruxtecan, has shown promising results, extending median OS by 3.3 months compared to standard therapies [10]. - Claudin18.2 is emerging as a promising target, with Zolbetuximab recently approved for use in combination with chemotherapy [12]. Group 4: Domestic Market Dynamics - China accounts for approximately 40% of the global gastric cancer cases, creating a significant market opportunity for domestic pharmaceutical companies [15]. - Companies like Hengrui and Rongchang Biopharma are actively developing innovative therapies targeting HER2 and Claudin18.2, with ongoing clinical trials showing encouraging results [16][19]. - The competitive landscape is intensifying as domestic firms explore new targets such as MET and FGFR2b, aiming to address unmet medical needs in gastric cancer treatment [20][21].