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全球第二款!FDA授予辉瑞CD3/BCMA双特异性抗体优先审评

2023-02-23


全球第二款!FDA授予辉瑞CD3/BCMA双特异性抗体优先审评

辉瑞宣布美国食品药品监督管理局(FDA)已授予其CD3/BCMA双特异性抗体elranatamab的生物制品许可申请(BLA)优先审评资格,预计FDA将在2023年对该申请做出决定。这也预示着,elranatamab有望继强生/Genmab的teclistamab之后,成为全球第二款获批上市的CD3/BCMA双特异性抗体。同时,欧洲药品管理局(EMA)也已接受了elranatamab的上市许可申请(MAA)。

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