智通财经APP讯，诺诚健华(688428.SH)发布公告，公司收到国家药品监督管理局(NMPA)的通知，公司靶向CD19的产品坦昔妥单抗(tafasitamab)(商品名：明诺凯®)联合来那度胺治疗不适合自体干细胞移植条件的复发/难治性弥漫性大B细胞淋巴瘤(以下简称“r/rDLBCL”)成人患者的上市申请获得批准，这是中国首个获批治疗r/rDLBCL的CD19单抗。
DLBCL是非霍奇金淋巴瘤(以下简称“NHL”)中最常见的一种类型，其全球发病率占NHL的31%至34%。在中国，DLBCL占所有NHL的45.8%。(数据来源：中华医学会血液学分会)坦昔妥单抗(tafasitamab)是一款靶向CD19的Fc结构域优化的人源化单克隆抗体，通过抗体依赖性细胞介导的细胞毒作用(ADCC)和抗体依赖性细胞吞噬作用(ADCP)等细胞凋亡和免疫效应机制介导B细胞肿瘤的裂解。
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