Core Insights - GFH375 has shown promising efficacy and safety in treating KRAS G12D mutation pancreatic ductal adenocarcinoma (PDAC) patients, with a reported objective response rate of 40.7% and a disease control rate of 96.7% [1][2] - The KRAS G12D mutation is prevalent, affecting nearly 30% of KRAS mutations, indicating a significant unmet clinical need in the patient population [2] - The collaboration between the company and Verastem for the development of GFH375 marks a strategic partnership aimed at expanding the drug's market reach outside of China [3] Group 1 - GFH375's clinical trial data presented at the ESMO 2025 conference highlighted its effectiveness in a cohort of 59 advanced PDAC patients, with a median progression-free survival of 5.52 months and a 4-month overall survival rate of 92.2% [1] - The drug has received FDA fast track designation and is set to enter I/II phase trials in June 2024, targeting both first-line and subsequent-line treatments for advanced KRAS G12D mutation PDAC patients [2] - The chief medical officer of the company emphasized the rapid clinical progress and the significant unmet needs of KRAS G12D mutation patients, indicating plans for further research in both subsequent and frontline treatments [2] Group 2 - GFH375 is an oral, highly selective small molecule KRAS G12D inhibitor that disrupts the activation of downstream pathways, effectively inhibiting tumor cell proliferation [2] - The partnership with Verastem grants exclusive rights to develop and commercialize GFH375 outside of Greater China, while the company retains rights within China [3] - The collaboration is contingent upon achieving predefined milestones in the I phase clinical trials, with GFH375 being the lead project for Verastem [3]
劲方医药-B(02595)：KRAS G12D抑制剂GFH375治疗晚期胰腺导管腺癌研究数据呈列于2025年ESMO年会口头报告及突破性研究摘要