3 月 3 日,CDE 官网显示,诺和诺德“司美格鲁肽注射液”新适应症在国内申报上市,并拟纳入优先审评,适应症为:用于治疗代谢相关脂肪性肝炎(MASH)伴中重度肝纤维化(符合 F2-F3 期纤维化)的非肝硬化成人患者。截图来自:CDE 官网2025 年 8 月,美国食品药品监督管理局(FDA)已基于一份补充新药申请(sNDA),批准了司美格鲁肽(2.4mg)的新适应症,用于治疗伴有中度至重度肝...
Source Link3 月 3 日,CDE 官网显示,诺和诺德“司美格鲁肽注射液”新适应症在国内申报上市,并拟纳入优先审评,适应症为:用于治疗代谢相关脂肪性肝炎(MASH)伴中重度肝纤维化(符合 F2-F3 期纤维化)的非肝硬化成人患者。截图来自:CDE 官网2025 年 8 月,美国食品药品监督管理局(FDA)已基于一份补充新药申请(sNDA),批准了司美格鲁肽(2.4mg)的新适应症,用于治疗伴有中度至重度肝...
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