2025年初,迪哲医药研发的肺癌靶向药舒沃哲®(舒沃替尼片)向美国FDA递交新药上市申请并获得优先审评资格,这一消息在医药行业引起了广泛关注。就在7月3日,该药正式获得FDA批准上市,用于经治EGFR Exon20ins晚期非小细胞肺癌(NSCLC)患者,成为中国首款独立研发在美获批的全球首创(First-in-Class)新药。 美国是全球最主要的医药市场,FDA 获批不仅是对药物本身的认可,...
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