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諾誠健華(688428.SH):國家藥品監督管理局受理tafasitamab聯合來那度胺治療復發或難治性瀰漫性大B細胞淋巴瘤的生物製品許可

格隆匯6月20日丨諾誠健華(688428.SH)公佈,創新藥tafasitamab(坦昔妥單抗)與來那度胺聯合治療不適合作自體幹細胞移植(ASCT)的復發或難治性瀰漫性大B細胞淋巴瘤(DLBCL)的成年患者的生物製品許可(BLA),近日已獲國家藥品監督管理局(NMPA)藥品審評中心(CDE)受理並納入優先審評。

Tafasitamab是一款靶向CD19的Fc結構域優化的人源化單克隆抗體。Tafasitamab包含XmAb(Xencor,Inc.的註冊商標)工程化Fc結構域,通過抗體依賴性細胞介導的細胞毒作用(ADCC)和抗體依賴性細胞吞噬作用(ADCP)等細胞凋亡和免疫效應機制介導B細胞腫瘤的裂解。

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