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百濟神州(06160.HK):倍利妥®在中國獲批用於治療兒童復發或難治性前體B細胞急性淋巴細胞白血病

格隆匯5月4日丨百濟神州(06160.HK)公佈,於2022年5月4日宣佈中國國家藥品監督管理局(NMPA)已批准倍利妥®(注射用貝林妥歐單抗,BLINCYTO®)用於治療兒童復發或難治性(R/R)CD19陽性的前體B細胞急性淋巴細胞白血病(ALL)。此前,倍利妥®已於2020年12月獲得NMPA附條件批准,用治療這一適應症的成人患者。

倍利妥®是由安進公司開發,百濟神州根據雙方2020年達成的全球腫瘤戰略合作,獲得其在中國的授權。此次上市申請獲批是倍利妥®在中國獲得的第二項批准。這一項用兒童適應症的新增生物製品上市許可申請(sBLA)是由百濟神州遞交。

百濟神州公司總裁、首席運營官兼中國區總經理吳曉濱博士表示:"倍利妥®是首款獲批用兒童R/R前體B細胞ALL的雙特異性免疫療法,我們很高興此次獲批使得我們有機會為中國的患兒帶來這一治療選擇。我們迫切希望將倍利妥®帶給國內有需要的患者,説明這些孩子及其家庭對抗疾病。目前,我們在中國的商業團隊規模不斷髮展壯大,已有超過3,100位員工,能夠將倍利妥®的這一適應症納入目前我們擁有的16款已上市抗腫瘤療法的廣泛治療組合中,這讓我們倍感興奮。"

此前倍利妥®獲得附條件批准用治療成人復發或難治性CD19陽性前體B細胞ALL患者,是基在中國以外開展的臨牀試驗數據,以及在中國針對成人患者開展的3期臨牀試驗(NCT03476239)的期中分析結果。而此次其獲得附條件批准用治療這一適應症的兒童人羣,是基在中國以外開展的研究數據以及中國成人患者的臨牀數據。對這一適應症的完全批准,將取決中國上市後研究的結果。

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