百濟神州(06160.HK):倍利妥在中國獲批用於急性淋巴細胞白血病
百濟神州(06160.HK)公布,於12月7日(美國東部時間)中國國家藥品監督管理局(NMPA)已批准倍利妥(BLINCYTO,注射用貝林妥歐單抗)用於治療成人復發或難治性(R/R)前體B細胞急性淋巴細胞白血病(ALL)。
此項生物製品上市許可申請(BLA)由安進公司遞交,並被NMPA藥品審評中心(CDE)納入優先審評。倍利妥由安進公司開發,百濟神州根據今年早先達成的全球腫瘤戰略合作獲得其在中國的授權。該上市申請獲批是倍利妥在中國的首項獲批,也是百濟神州從安進公司授權引進產品中首款全新獲批的產品。倍利妥也就該項獲批成為中國首款獲批的雙特異性免疫藥物。
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