Core Viewpoint - The company, Fuhong Hanlin (02696), has announced that its self-developed drug, Hanshu (Sru Li Antibody Injection), has met the primary endpoint of event-free survival (EFS) in a Phase 3 clinical trial for the treatment of early gastric cancer, supporting an early application 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 independent data monitoring committee (IDMC) conducted a pre-specified interim analysis, which showed significant improvement in EFS for the Hanshu combination therapy compared to the placebo group [1] Group 2: Efficacy and Safety Results - The pathological complete response (pCR) rate for the Hanshu group was more than three times that of the control group, indicating a substantial efficacy advantage [1] - The risk of recurrence for patients receiving Hanshu was significantly reduced, and no new safety signals were identified, demonstrating good safety [1]
复宏汉霖：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