Core Insights - The company, Fuhong Hanlin (02696), announced that its self-developed Hanshuo® (sulunatuzumab injection) has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for the treatment of gastric cancer, supporting early market application [1] Group 1: Clinical Trial Details - The Phase 3 clinical trial is a randomized, double-blind, multi-center study comparing Hanshuo® combined with chemotherapy to placebo combined with chemotherapy for early gastric cancer patients [1] - The independent data monitoring committee (IDMC) conducted a pre-specified interim analysis, showing significant improvement in EFS for the Hanshuo® group compared to the placebo group, achieving the predefined superiority criteria [1] Group 2: Efficacy and Safety - The pathological complete response (pCR) rate for the Hanshuo® 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 Hanshuo® 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