Bayer announced the submission of marketing authorization applications to the FDA and to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), seeking approval of finerenone in the U.S. and in China for adult patients with HF with a left ventricular ejection fraction (LVEF) of ≥40%, i.e.

拜耳宣布向FDA和中国国家医药产品管理局（NMPA）药物评估中心（CDE）提交上市授权申请，寻求美国和中国对左心室射血分数（LVEF）≥40%的成年HF患者（即。

mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF)..

轻度降低LVEF（HFmrEF）或保留LVEF（HFpEF）。。

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and the first drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with this common form of HF in the Phase III study FINEARTS-HF.

Fineenone是一种非甾体选择性盐皮质激素受体拮抗剂（nsMRA），是第一种靶向盐皮质激素受体（MR）途径的药物，在III期研究FINEARTS-HF中已证明这种常见形式的HF患者具有心血管益处。

Finerenone is already marketed as Kerendia or, in some countries, as Firialta and approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S.

非格列酮（Finerenone）已作为 Kerendia 或在某些国家作为 Firialta 上市，并在全球 90 多个国家（包括中国、欧洲、日本和美国）获准用于治疗与 2 型糖尿病（T2D）相关的慢性肾病（CKD）成年患者。

Heart failure (HF) affects over 60 million people worldwide and is a rapidly growing public health issue. Approximately half of these patients suffer from HF with a LVEF of ≥40%.

心力衰竭（HF）影响全球6000多万人，是一个迅速增长的公共卫生问题。这些患者中约有一半患有HF，LVEF≥40%。

HF with a LVEF ≥40% is associated with multiple comorbidities, making the condition complex to manage. Time trends suggest this growing population will soon account for the majority of patients hospitalized with HF.

LVEF≥40%的HF与多种合并症有关，使病情复杂。时间趋势表明，这一不断增长的人口很快将占HF住院患者的大多数。

By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses key aspects of HF with an LVEF ≥40%, including hemodynamic factors and inflammatory and fibrotic processes. Results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of greater than or equal to 40%..

通过靶向MR和肾素-血管紧张素-醛固酮系统（RAAS）过度活化，finerenone解决了LVEF≥40%的HF的关键方面，包括血液动力学因素以及炎症和纤维化过程。III期研究FINEARTS-HF的结果表明，与安慰剂相比，Fineenone在心力衰竭（HF）和左心室射血分数（LVEF）大于或等于40%的患者的心血管结局方面显示出统计学上的显着改善。。

The New Drug Applications submitted to the  FDA and to the CDE of China’s National Medical Products Administration are based on positive data from

提交给FDA和中国国家医药产品管理局CDE的新药申请是基于来自

the FINEARTS-HF study,

FINEARTS-HF研究，

which is part of one of the largest Phase III clinical trial programs to date in HF with more than 15,000 patients in total, aiming to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.

这是迄今为止HF最大的III期临床试验计划之一，共有15000多名患者，旨在在广泛的患者和临床环境中全面了解HF中的芬尼酮。

FINEARTS-HF i

FINARTS-HF i

s a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III study investigating the efficacy and safety of finerenone (Kerendia) for the prevention of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) of ≥40%, measured by any modality within the last 12 months as well as receiving diuretic treatment for at least 30 days prior to randomization.

这是一项随机，双盲，安慰剂对照，多中心，事件驱动的III期研究，研究了finerenone（Kerendia）预防有症状心力衰竭（纽约心脏协会II-IV级）患者心血管死亡和心力衰竭（HF）事件的有效性和安全性，左心室射血分数（LVEF）≥40%，在过去12个月内通过任何方式测量，并在随机化前至少30天接受利尿剂治疗。

The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits. .

FINEARTS-HF的主要终点是心血管死亡和总（首次和复发）HF事件的综合，定义为HF住院或紧急HF就诊。。

Around 6,000 patients were randomized from more than 630 sites across 37 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities. With overall more than 15,000 patients, the ongoing MOONRAKER clinical trial program with finerenone, including FINEARTS-HF, is one of the largest HF study programs to date, and aims to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings..

从全球37个国家的630多个地点随机抽取约6000名患者，每天一次接受芬尼酮或安慰剂治疗。此外，研究中的患者接受常规治疗以治疗症状和合并症。包括FINEARTS-HF在内的Fineenone正在进行的MOONRAKER临床试验项目共有15000多名患者，是迄今为止最大的HF研究项目之一，旨在广泛了解HF患者和临床环境中的Fineenone。。

“Heart failure represents a serious global health challenge, particularly for patients with a left ventricular ejection fraction of ≥40%, who are difficult to treat”, said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.

拜耳全球产品战略和商业化执行副总裁兼制药领导团队成员克里斯蒂娜·罗斯（ChristineRoth）表示：“心力衰竭是一个严重的全球健康挑战，特别是对于左心室射血分数≥40%的患者，他们很难治疗。”。

“If approved, finerenone could emerge as a new pillar of treatment for this common form of heart failure, offering the potential to improve cardiovascular outcomes for patients who currently have limited treatment options with proven efficacy.”.

“如果获得批准，finerenone可能会成为这种常见心力衰竭治疗的新支柱，为目前疗效有限的治疗选择提供改善心血管结局的潜力。”。