智通财经APP讯，诺诚健华(09969)发布公告，国家药品监督管理局(NMPA)已批准 Minjuvi® (tafasitamab)(一款靶向CD19的Fc结构域优化的人源化细胞溶解单克隆抗体)与来那度胺联合治疗(之后是Minjuvi单药治疗)不适合作自体干细胞移植 (ASCT)的复发或难治性弥漫性大B细胞淋巴瘤(DLBCL)的成年患者。这是中国首款获批用于治疗复发或难治性DLBCL的CD19抗体。
Tafasitamab(坦昔妥单抗，一款靶向CD19的Fc结构域优化的人源化细胞溶解免疫疗法)加来那度胺联合疗法已获准于香港、澳门及台湾地区治疗符合条件的 DLBCL患者。此外，根据博鳌乐城国际医疗旅游先行区及粤港澳大湾区的先行项目，tafasitamab联合来那度胺的处方已在瑞金海南医院及广东祈福医院为符合条件的DLBCL患者给药。
Tafasitamab已经获得美国食品药品监督管理局(FDA)加速批准以及欧洲药品管理局(EMA)有条件批准与来那度胺联合治疗不符合ASCT条件的复发或难治 DLBCL成人患者。
DLBCL是非霍奇金淋巴瘤(NHL)中最常见的一种类型，其全球发病率占NHL的 31%至34%。根据中华医学会血液学分会，在中国，DLBCL占所有NHL病例的 45.8%。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.