賽生藥業(06600.HK):國家藥監局受理DANYELZA®(那昔妥單抗)上市許可申請
格隆匯7月13日丨賽生藥業(06600.HK)發佈公吿,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(“BLA”),適應症為治療復發╱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(“FDA”)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月獲得其加速批准。
公司於2020年12月與Y-mAbs訂立許可協議,擔任DANYELZA®(那昔妥單抗)及omburtamab於大中華(包括中國大陸、中國香港、中國澳門及中國台灣)的獨家共同開發及商業化夥伴。如獲批准,omburtamab乃用作治療患有CNS╱神經母細胞瘤的軟腦膜轉移的兒科患者。賽生藥業將負責在該地區研發、註冊及商業化該兩個產品。
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