劲方医药：KRAS G12D拟纳入突破疗法，二线治疗NSCLC

医药笔记02-14

▎Armstrong2026年2月13日，劲方医药KRAS G12D抑制剂GFH375拟纳入突破治疗药物程序，用于至少接受过一种系统性治疗并具有KRAS G12D突变的非小细胞肺癌（NSCLC）患者。GFH375为一款高选择性的强效KRAS G12D（on/off）双重作用机制的抑制剂。GFH375在KRAS G12D的竞争格局中处于领先地位。去年8月，劲方医药披露了GFH375治疗NSCLC的1...

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href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN2026021411065197a628b6&s=b><strong>医药笔记</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>▎Armstrong2026年2月13日，劲方医药KRAS G12D抑制剂GFH375拟纳入突破治疗药物程序，用于至少接受过一种系统性治疗并具有KRAS G12D突变的非小细胞肺癌（NSCLC）患者。GFH375为一款高选择性的强效KRAS G12D（on/off）双重作用机制的抑制剂。GFH375在KRAS G12D的竞争格局中处于领先地位。去年8月，劲方医药披露了GFH375治疗NSCLC的1...</p>\n\n<a 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G12D抑制剂GFH375拟纳入突破治疗药物程序，用于至少接受过一种系统性治疗并具有KRAS G12D突变的非小细胞肺癌（NSCLC）患者。GFH375为一款高选择性的强效KRAS G12D（on/off）双重作用机制的抑制剂。GFH375在KRAS G12D的竞争格局中处于领先地位。去年8月，劲方医药披露了GFH375治疗NSCLC的1/2期临床数据。26例可评估NSCLC患者的ORR为57.7%、疾病控制率DCR为88.5%，其中600 mg QD (RP2D)剂量组ORR为68.8%、DCR为93.8%。mPFS尚未达到，4个月PFS率超过75%。总结GFH375治疗NSCLC的疗效优异，与同类产品相比获得更优异的疗效数据，具有成为同类最佳的潜力。劲方医药围绕GFH375制定了积极的临床开发方案，同时探索胰腺癌、非小细胞肺癌、结直肠癌、胆管癌等多个瘤种。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir 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