智通财经APP讯，复星医药(600196.SH)发布公告，近日，公司控股子公司复星凯瑞(上海)生物科技有限公司(简称“复星凯瑞”)就布瑞基奥仑赛注射液(项目代号：FKC889，申请注册分类：治疗用生物制品3.2类;以下简称“该产品”)的药品注册申请获国家药品监督管理局受理，本次申报适应症为用于治疗复发或难治性前体B细胞急性淋巴细胞白血病(ALL)成人患者。
该产品系复星凯瑞基于自Kite Pharma,Inc.(系Gilead Sciences,Inc.的控股子公司)引进的Tecartus经技术转移并获授权于中国(包括中国香港、澳门)进行开发及本地化生产的靶向CD19的CAR-T细胞治疗产品。Tecartus已于2020年7月及12月先后于美国、欧洲获批上市。
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