智通财经APP获悉，4月2日，诺华(NVS.US)宣布盐酸伊普可泮胶囊获得中国国家药品监督管理局(NMPA)批准新适应症，用于治疗成人C3肾小球病(C3G)以降低蛋白尿。该产品能帮助患者有效控制蛋白尿，稳定eGFR(估算肾小球滤过率)。伊普可泮是一款特异性补体B因子口服抑制剂。本次是该产品在中国获批的第二项适应症，此前其已经于2024年4月获NMPA批准用于治疗PNH成人患者。
根据诺华新闻稿，研究显示，伊普可泮可快速降低蛋白尿，且实现了具有临床意义的蛋白尿水平下降。最早在第14天见效，6个月蛋白尿较安慰剂显著降低35%，12个月肾小球滤过率(eGFR)持续稳定。
C3肾小球病是原发性肾小球肾炎的一种罕见和严重形式，以补体失调为特征。公开资料显示，大部分C3肾小球病患者最终需要面对改变生活的肾脏透析或者移植。由于目前没有获批疗法，患者具有严重未满足的临床需求。
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