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展商 展品

安卫力

展商:Takeda Pharmaceutical Company Limited

原产国/地区:日本

安卫力(莫博赛替尼)是全球首款、也是目前唯一一款专门用于EGFR20号外显子插入突变阳性非小细胞肺癌患者的口服疗法,已在美国、英国、瑞士、澳大利亚和韩国获得当地监管机构批准。武田于2021年递交中国上市许可申请(NDA),并于当年7月获得国家药品监督管理局药品审评中心(CDE)受理,获准纳入优先审评审批程序,拟用于治疗携带表皮生长因子受体(EGFR)20号外显子插入突变的非小细胞肺癌(NSCLC)成人患者。

展品详情

Mobocertinib is the first and only oral therapy specifically designed for patients with EGFR exon 20 insertion mutation positive non-small cell lung cancer. It has been approved by local regulatory authorities in the United States, Britain, Switzerland, Australia and South Korea. Takeda submitted New Drug Application(NDA) in China in 2021 and was accepted by the Center for  Drug Evaluation (CDE) in July in same year. It was authorized priority review for the treatment of adult patients with non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) exon 20 insertion mutation.