阿斯利康“戈鲁利单抗”国内申报上市，自免双抗新药剑指全身型重症肌无力

摩熵医药2025-12-25

12月24日，据CDE网站显示，阿斯利康的戈鲁利单抗（gefurulimab）在国内申报上市。根据临床试验进展，推测此次申报的适应症为全身型重症肌无力（gMG）。截图来源：CDE戈鲁利单抗是一种结构紧凑的双特异抗体（约25 kDa），其设计极为精简，仅包含靶向补体C5的重链可变区与特异性结合白蛋白的抗体片段。该结构赋予其两大关键优势：较小的分子尺寸有助于提升组织渗透性，而与白蛋白的结合可显著延长其...

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