智通财经APP获悉，近日，罗氏(RHHBY.US)公布奥妥珠单抗治疗活动性狼疮肾炎患者的III期REGENCY研究的详细分析，并发表于《新英格兰医学杂志》。研究显示，接受奥妥珠单抗+标准疗法（霉酚酸酯和糖皮质激素）治疗的患者有46.4%在76周时实现了完全肾脏缓解 （CRR），而接受标准疗法的患者有33.1%达到了CRR（调整后差异为13.4%，95% CI：2.0%-24.8%；P=0.0232）。
与此同时，联合治疗组相较于标准治疗组的补体水平也实现了临床意义的改善，抗dsDNA抗体、疾病活动和炎症标志物也有所降低。
罗氏表示，奥妥珠单抗是全球首款在狼疮性肾炎随机III期临床试验中证明完全肾脏缓解（CRR）获益的CD20单抗。根据2024年财报，罗氏已于2024年12月向FDA递交狼疮性肾炎新适应症的上市申请。这意味着，奥妥珠单抗将成为首个获得FDA批准用于治疗狼疮性肾炎的CD20靶向疗法。
奥妥珠单抗于2013年在美获批上市，属于第三代Fc段经修饰的II型CD20单抗。目前该药物已获批3项适应症，皆用于血液瘤，包括慢性淋巴细胞白血病、滤泡性淋巴瘤、小淋巴细胞性淋巴瘤。
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