罗氏(RHHBY.US)突破性疗法递交监管申请

智通财经2025-03-06

智通财经APP获悉，罗氏(RHHBY.US)今天宣布，美国FDA已接受该公司为抗CD20抗体obinutuzumab递交的补充生物制品许可申请(sBLA)，用于治疗狼疮性肾炎。FDA预计在2025年10月前完成审评。新闻稿指出，obinutuzumab是首个在狼疮性肾炎随机3期临床试验中显示出完全肾脏缓解(CRR)益处的抗CD20单克隆抗体。Obinutuzumab是一种抗CD20人源化单克隆抗体...

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