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百济神州(06160.HK):迪妥昔单抗在中国之上 市申请已获受理
阿思达克 11-10 08:56
百济神州(06160.HK)公布,中国国家药品监督管理局(NMPA)已受理QARZIBA(迪妥昔单抗)的上市许可申请(BLA)并纳入优先审评。

迪妥昔单抗是一款靶向肿瘤免疫疗法,已获欧洲药品管理局(EMA)批准用於治疗一岁以上先前接受过诱导化疗并达到部分缓解的高危神经母细胞瘤患者,随後进行清髓性治疗和干细胞移植,或者复发或难治性神经母细胞瘤的患者,无论是否有残留病灶。高危神经母细胞瘤是一种具有侵袭性的赘生物,也是儿童中最常见起源於脑外的实体瘤。迪妥昔单抗位列NMPA首批临床急需境外新药名单。

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