Reported Wednesday, China's NMPA Approves GenFleet And Verastem Oncology's GFH375 For KRAS G12D Phase I/II Trials
Reported Wednesday, China's NMPA Approves GenFleet And Verastem Oncology's GFH375 For KRAS G12D Phase I/II Trials
据周三报道，中国国家药品监督管理局批准GenFleet和verastem公司的GFH375进行KRASG12D分Ⅰ/Ⅱ期临床试验。
GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced China's National Medical Products Administration (NMPA) has approved the clinical trial application for GFH375 (VS-7375) in an open-label, multi-center phase I/II study targeting advanced solid tumor patients with KRAS G12D mutation. G12D mutation is the most prevalent KRAS mutation detected in human cancers, and no G12D-targeted therapies have been approved yet.
GenFleet Therapeutics是一家临床生物技术公司，致力于肿瘤学和免疫学领域的尖端治疗方案。该公司宣布，中国国家药品监督管理局已批准GFH375（VS-7375）的临床试验申请，该试验为开放标签、多中心I/II期研究，针对具有KRAS G12D突变的晚期实体肿瘤患者。G12D突变是人类肿瘤中检测到的最普遍的KRAS突变，尚未批准任何G12D靶向治疗。