劲方医药-B：GFH375治疗转移性胰腺癌注册性临床试验在首家研究中心启动 为全球首个口服KRAS G12D抑制剂单药对照化疗III期研究

Core Viewpoint - The announcement highlights the initiation of a pivotal Phase III trial (GFH375X1301) for the oral KRAS G12D inhibitor GFH375, targeting previously treated patients with KRAS G12D mutation metastatic pancreatic cancer, marking a significant advancement in the treatment landscape for this aggressive cancer type [1][2]. Group 1: Clinical Development - The Phase III trial will be conducted at approximately 40 centers, aiming to enroll around 320 patients who have previously received at least one standard systemic treatment for metastatic pancreatic cancer [2]. - GFH375 is currently in the leading tier of global oral KRAS G12D inhibitors, with multiple clinical explorations ongoing both in China and internationally [1][2]. Group 2: Market Context and Need - Pancreatic cancer is characterized by high malignancy and poor prognosis, with a 5-year survival rate of less than 10%, and the global incidence of new cases is projected to exceed 770,000 by 2037 [2]. - Approximately 40% of pancreatic cancer patients exhibit the KRAS G12D mutation, which is an independent prognostic marker associated with poor response rates and overall survival in advanced PDAC [2]. Group 3: Company Insights - The Chief Medical Officer of the company emphasized that this is the first global oral RAS inhibitor clinical study for pancreatic cancer, showcasing the company's capabilities in clinical research and integrated drug development [3]. - The company anticipates positive outcomes from the GFH375X1301 study, which could benefit patients and lead to further breakthroughs in targeted therapies for pancreatic cancer [3].