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賽生藥業(06600.HK)遞交那昔妥單抗中國上市許可申請
阿思達克 07-07 10:07
賽生藥業(06600.HK)宣布,向國家藥品監督管理局正式遞交那昔妥單抗「DANYELZA」的上市許可申請,申請有待藥監局受理及審評審批。

那昔妥單抗可與粒細胞-巨噬細胞集落刺激因子(GM-CSF)聯合治療對既往治療表現出部分緩解、輕微緩解或疾病穩定的複發/難治性高危神經母細胞瘤兒童(1歲及以上)和成人患者。

賽生藥業於去年12月與Y -mAbs Therapeutics(YMAB.US)達成獨家無限期授權許可協議,獲授予那昔妥單抗和omburtamab在大中華地區的獨家合作開發和商業化權利。

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