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重大突破!复宏汉霖(2696.HK)H药胃癌围手术期III期临床研究达到主要终点 为该领域全球首个治疗方案
Ge Long Hui· 2025-10-09 12:15
Core Insights - The company announced that its self-developed innovative PD-1 inhibitor, Hanshuo® (Slulizumab), achieved the primary endpoint of event-free survival (EFS) in a Phase III clinical study for gastric cancer, marking a significant breakthrough in the field [1] Group 1: Clinical Study Results - The interim analysis by the independent data monitoring committee showed that the study met the predefined efficacy standards [1] - Hanshuo® combined with chemotherapy significantly improved EFS compared to placebo combined with chemotherapy, with a pathological complete response (pCR) rate more than three times that of the control group [1] - The treatment regimen demonstrated good safety, with no new safety signals identified [1] Group 2: Company Strategy and Future Plans - The CEO of the company emphasized that gastrointestinal tumors are a core area of focus for the company, and the achievement in the Phase III study represents a key breakthrough [1] - The company plans to actively promote the translation of these results to benefit patients and will continue to accelerate the exploration and application of more innovative therapies [1]
全球首个!复宏汉霖(02696)H药胃癌围术期III期达到主要终点 支持提前申报上市
智通财经网· 2025-10-09 11:32
Group 1 - The company announced that its self-developed innovative PD-1 inhibitor, Hanshuozhuang (Slulizumab), achieved the primary endpoint of event-free survival (EFS) in the interim analysis of the Phase III clinical study (ASTRUM-006) for gastric cancer, marking a significant breakthrough in the field [1] - The ASTRUM-006 study is a randomized, double-blind, multi-center Phase III clinical trial aimed at evaluating the clinical efficacy and safety of Hanshuozhuang combined with chemotherapy compared to placebo combined with chemotherapy in early gastric cancer patients [1] - The independent data monitoring committee reported that the study met the pre-set superiority criteria, with Hanshuozhuang combined with chemotherapy significantly improving EFS and achieving a pathological complete response (pCR) rate more than three times that of the control group, while showing good safety without new safety signals [1] Group 2 - The company focuses on gastrointestinal tumors, including esophageal, gastric, and colorectal cancers, and has developed a diversified product portfolio that includes immunotherapy and targeted drugs, covering different molecular types and disease stages [2] - The company aims to leverage its multi-layered innovative therapy matrix and extensive global multi-center clinical trial data to maintain its leading advantage in the gastrointestinal tumor field [2]