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賽生藥業(06600.HK)那昔妥單抗上市許可申請獲內地受理

阿思達克 07-13 08:25
賽生藥業(06600.HK)宣佈，中國國家藥品監督管理局已受理DANYELZA(那昔妥單抗)生物製品許可申請，適應症爲治療復發/難治性高危神經母細胞瘤。

DANYELZA(那昔妥單抗)被美國食品藥品監督管理局授予優先評審，獲得突破治療和孤兒藥資格，並基於總體緩解率和緩解持續時間於2020年11月獲得其加速批準。

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