诺和诺德，司美格鲁肽新适应症申报上市_老虎社区_美港股上老虎

诺和诺德，司美格鲁肽新适应症申报上市

药圈大门03-03 18:20

3月3日，CDE官网显示，诺和诺德的司美格鲁肽注射液新适应症在国内申报上市，并被拟纳入优先审评。此次申报的适应症为治疗代谢相关脂肪性肝炎（MASH）伴中重度肝纤维化的非肝硬化成人患者。这并非司美格鲁肽首次在该适应症上获得监管认可。2025年8月，美国FDA已基于补充新药申请批准司美格鲁肽（2.4mg）用于治疗伴有中度至重度肝纤维化的非肝硬化MASH成年患者，需联合低热量饮食和增加体力活动。此次加速...

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