12月23日,中国国家药监局(NMPA)官网最新公示,罗氏(RHHBY.US)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。
截图来源:NMPA官网
据悉,莫妥珠单抗(Lunsumio)是一款CD20/CD3 T细胞衔接双特异性抗体,它可以引导患者体内的T细胞迁移到目标B细胞附近,并且释放细胞毒性的蛋白消灭B细胞。该药此前曾获FDA授予突破性疗法认定和孤儿药资格。2022年6月,莫妥珠单抗在欧盟获批,用于治疗复发/难治性滤泡性淋巴瘤成人患者,他们已经接受过至少两种前期系统治疗。同年12月,该产品获得美国FDA批准,治疗经治复发或难治的FL成年患者。
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