金吾财讯 | 信达生物(01801)宣布,重组抗胰岛素样生长因子1受体(“IGF-1R”)抗体信必敏(替妥尤单抗N01注射液)的新药上市申请(“NDA”)获中国国家药品监督管理局(“NMPA”)批准上市,用于治疗甲状腺眼病(Thyroid Eye Disease,TED)。信必敏是中国首个、全球第二款获批的IGF-1R抗体药物,也是中国甲状腺眼病治疗领域70年来的首款新药,将重塑甲状腺眼病的治疗标准。甲状腺眼病是与甲状腺疾病密切相关的一种器官特异自身免疫性疾病,位居成人眼眶疾病发病率首位,在40-60岁年龄段尤其高发。
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