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百济神州(06160.HK):倍利妥在中国获批用於急性淋巴细胞白血病
阿思达克 12-09 08:17
百济神州(06160.HK)公布,於12月7日(美国东部时间)中国国家药品监督管理局(NMPA)已批准倍利妥(BLINCYTO,注射用贝林妥欧单抗)用於治疗成人复发或难治性(R/R)前体B细胞急性淋巴细胞白血病(ALL)。

此项生物制品上市许可申请(BLA)由安进公司递交,并被NMPA药品审评中心(CDE)纳入优先审评。倍利妥由安进公司开发,百济神州根据今年早先达成的全球肿瘤战略合作获得其在中国的授权。该上市申请获批是倍利妥在中国的首项获批,也是百济神州从安进公司授权引进产品中首款全新获批的产品。倍利妥也就该项获批成为中国首款获批的双特异性免疫药物。

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