劲方医药（上海）有限公司旗下创新药物GFH375近日获得中国国家药品监督管理局药品审评中心（CDE）授予的突破性治疗药物程序认定。这是国内首个针对KRAS G12D突变抑制剂的突破性疗法认定，标志着公司在肿瘤靶向治疗领域取得重大进展。
GFH375作为高选择性KRAS G12D口服小分子抑制剂，通过不可逆结合方式特异性抑制KRAS G12D蛋白活性。该突变常见于胰腺癌、结直肠癌和非小细胞肺癌等恶性肿瘤，此前全球范围内尚未有靶向该突变的上市药物。
突破性治疗药物程序将加速GFH375的临床开发和审评进程，为存在KRAS G12D突变的晚期实体瘤患者提供新的治疗希望。目前GFH375正在中国开展多中心Ⅰ期临床研究，初步数据显示出良好的安全性和抗肿瘤活性。
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