泰它西普,首个申报

动脉网
Oct 16

10月15日,荣昌生物宣布其自主研发的全球首创BLyS/APRIL双靶点融合蛋白创新药泰它西普,用于治疗原发性免疫球蛋白A(IgA)肾病的上市申请获CDE受理,并纳入优先审评程序,成为该领域首个申报上市的国产原研新药。泰它西普能同步抑制BLyS和APRIL,从源头上抑制异常免疫球蛋白生成,阻断肾脏损伤进程。III期临床研究A阶段显示,泰它西普显著降低患者24小时尿蛋白肌酐比值,且耐受性和安全性良好...

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