罗氏(RHHBY)莫妥珠单抗注射液在华批准上市

金吾财讯2024-12-23

金吾财讯 | 据中国国家药监局(NMPA)官网最新公示，罗氏(RHHBY)申报的莫妥珠单抗注射液(mosunetuzumab)上市申请已获得批准。根据中国国家药监局药品审评中心(CDE)优先审评公示，该药本次用于治疗既往接受过至少两种系统性治疗的复发或难治性滤泡性淋巴瘤(FL)成人患者。公开资料显示，莫妥珠单抗是一款靶向B细胞表面的CD20抗原和T细胞表面的CD3受体的T细胞衔接双特异性抗体。该药代表着一种无化疗、现货型新免疫治疗选择，并且可以在门诊输液治疗。

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