智通财经APP获悉，1月24日，中国国家药监局药品审评中心(CDE)官网最新公示，拜耳(BAYRY.US)非奈利酮片的新适应症上市申请获得受理。拜耳本月上旬发布的新闻稿显示，其已经在中国和美国同时递交非奈利酮(finerenone)心力衰竭适应症上市申请，用于左心室射血分数(LVEF)≥40%的成年心衰患者，即左心室射血分数轻度降低(HFmrEF)或左心室射血分数保留(HFpEF)的心衰患者。

心衰是发病人数增长最快的心血管疾病，其中约一半是LVEF≥40%的心衰，这类心衰与多种疾病相关，病情复杂、难以管理。时间趋势分析也表明，LVEF≥40%的心衰患者很快占住院心衰患者的大多数。通过针对MR和肾素-血管紧张素-醛固酮系统(RAAS)过度激活，非奈利酮针对LVEF≥40%心衰的发病机制而发挥作用，如进行性纤维化问题。

具体而言，试验结果显示，在LVEF≥40%的心力衰竭患者中，非奈利酮将心血管死亡和总心力衰竭事件构成的复合临床指标降低16%，达成试验主要终点。这项研究的积极数据意味着非奈利酮的作用不局限于伴有T2D的慢性肾脏疾病患者群体，也能为心力衰竭(LVEF≥40%)患者提供临床获益。

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