Core Insights - The company, Junshi Biosciences (复宏汉霖), has announced that its self-developed drug, Hanshu (Sruilumab injection), has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for gastric cancer, allowing for early submission for market approval [1] Group 1: Clinical Trial Details - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hanshu combined with chemotherapy against a placebo combined with chemotherapy for early gastric cancer patients [1] - The interim analysis conducted by the Independent Data Monitoring Committee (IDMC) showed significant improvement in EFS for the Hanshu group compared to the placebo group, meeting the predefined superiority criteria [1] Group 2: Efficacy and Safety - The pathological complete response (pCR) rate for the Hanshu group was over three times that of the control group, indicating a substantial reduction in the risk of recurrence for patients [1] - The safety profile of Hanshu was reported to be good, with no new safety signals identified during the trial [1]
复宏汉霖(02696)：汉斯状® (斯鲁利单抗注射液)联合化疗用于胃癌新辅助/辅助治疗的3期临床研究达到主要研究终点