WHIPPANY, N.J.--(BUSINESS WIRE)--At the American Society of Nephrology’s (ASN) Kidney Week 2023, Bayer today announced pharmacodynamic data on Kerendia® (finerenone), the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate dual cardiorenal risk reduction in adult patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).

WHIPPANY，N.J。-在美国肾脏病学会（ASN）肾脏周2023年，拜耳今天宣布了Kerendia®（finerenone）的药效学数据，这是第一个非甾体选择性盐皮质激素受体（MR）拮抗剂，用于证明成人慢性肾病（CKD）和2型糖尿病（T2D）患者的双心肾风险降低。

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Kerendia is indicated to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with CKD associated with T2D.3 The Kerendia label contains a Warning and Precaution that Kerendia can cause hyperkalemia.

Kerendia可降低成人CKD合并T2D患者持续eGFR下降，终末期肾病，心血管死亡，非致死性心肌梗死和心力衰竭住院的风险.3 Kerendia标签包含警告和预防措施Kerendia可引起高钾血症。

For more information, see “Important Safety Information” below..

有关更多信息，请参阅下面的“重要安全信息”。。

The data from FIGARO-BM, an exploratory human biomarker study, provide findings which support the mechanism of action of Kerendia in blocking MR overactivation, thought to contribute to inflammation and fibrosis. Left untreated, inflammation and fibrosis can lead to damage in the kidneys and heart. 3.

来自FIGARO-BM（一项探索性人类生物标志物研究）的数据提供了支持Kerendia阻断MR过度活化的作用机制的发现，其被认为有助于炎症和纤维化。如果不及时治疗，炎症和纤维化会导致肾脏和心脏受损。三。

“The biomarker findings from FIGARO-BM are an important moment for Bayer,” said Dr. Christian Rommel, Member of the Executive Committee of Bayer AG's Pharmaceutical Division and Head of Research and Development. “In addition to existing preclinical data, we now have data from human biomarkers that support finerenone's mechanism of action in blocking MR overactivation which can lead to inflammation and fibrosis.”.

拜耳公司制药部门执行委员会成员，研发负责人克里斯蒂安·罗梅尔博士说：“FIGARO-BM的生物标志物发现是拜耳的重要时刻。“除了现有的临床前数据外，我们现在还拥有来自人类生物标志物的数据，这些数据支持finerenone阻断可导致炎症和纤维化的MR过度活化的作用机制。”。

The FIGARO-BM study aims to elucidate the mode-of-action (MOA) of finerenone. More than 2,900 plasma biomarkers derived from biosamples from 945 patients who were treated with either placebo or finerenone for at least 36 months in the Phase III study FIGARO-DKD were analyzed.1 Future studies are needed to validate these findings..

FIGARO-BM研究旨在阐明精细烯酮的作用方式（MOA）。在III期研究FIGARO-DKD中，分析了来自945名接受安慰剂或更精细酮治疗至少36个月的患者的生物样本的2900多种血浆生物标志物.1需要进一步的研究来验证这些发现。。

About Kerendia® (finerenone)4

关于Kerendia® （芬兰语）4

Kerendia is a non-steroidal mineralocorticoid receptor antagonist (MRA) approved by the FDA in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular (CV) death, non-fatal myocardial infarction, and hospitalization for heart failure (HF) in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D)..

Kerendia是FDA于2021年7月批准的一种非甾体盐皮质激素受体拮抗剂（MRA），用于降低持续eGFR下降，终末期肾病，心血管（CV）死亡，非致死性心肌梗死和住院治疗的风险。与2型糖尿病（T2D）相关的慢性肾病（CKD）成人患者的心力衰竭（HF）。。

Kerendia was studied in the largest CKD clinical trial program FIDELIO-DKD (Finerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) and FIGARO-DKD (Finerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) across a broad range of CKD severity in adults with CKD associated with T2D.

Kerendia在最大的CKD临床试验计划FIDELIO-DKD（Finerenone减少糖尿病肾病的肾功能衰竭和疾病进展）和FIGARO-DKD（Finerenone降低糖尿病肾病的心血管死亡率和发病率）中进行了广泛的研究。CKD与T2D相关的成人CKD严重程度。

In the Kerendia Phase III program for CKD associated with T2D with over 13,000 people, FIDELIO-DKD and FIGARO-DKD showed Kerendia reduced the risk of chronic kidney disease progression and CV events. Based on data from the clinical trial program, Kerendia has been recommended for adults with CKD associated with T2D in several major treatment guidelines, including the American Diabetes Association® (ADA), the American Association of Clinical Endocrinology®, and the Kidney Disease: Improving Global Outcomes® (KDIGO) Foundation as well as the ADA/KDIGO Consensus Statement..

在与超过13000人的T2D相关的CKD的Kerendia III期计划中，FIDELIO-DKD和FIGARO-DKD显示Kerendia降低了慢性肾病进展和CV事件的风险。根据临床试验计划的数据，Kerendia已被推荐用于几种主要治疗指南中与T2D相关的CKD成人，包括美国糖尿病协会（ADA），美国临床内分泌学会®和肾脏疾病：改善全球成果®（KDIGO）基金会以及ADA/KDIGO共识声明。。

IMPORTANT SAFETY INFORMATION

重要的安全信息

CONTRAINDICATIONS:

禁忌症：

Concomitant use with strong CYP3A4 inhibitors

与强CYP3A4抑制剂同时使用

Patients with adrenal insufficiency

肾上腺皮质功能不全患者

WARNINGS AND PRECAUTIONS:

警告和注意事项：

Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly.

高钾血症：KERENDIA可引起高钾血症。发生高钾血症的风险随着肾功能的降低而增加，而基线钾水平较高或其他高钾血症危险因素的患者风险更高。在开始用KERENDIA治疗之前测量所有患者的血清钾和eGFR并相应地给药。

Do not initiate KERENDIA if serum potassium is >5.0 mEq/L. .

如果血清钾>5.0 mEq/L，则不要引发KERENDIA。

Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium.

在用KERENDIA治疗期间定期测量血清钾并相应地调整剂量。对于有高钾血症风险的患者，包括那些同时服用损害钾排泄或增加血钾的药物的患者，可能需要更频繁的监测。

MOST COMMON ADVERSE REACTIONS:

最常见的不良反应：

From the pooled data of 2 placebo-controlled studies, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% versus 6.9%), hypotension (4.6% versus 3.9%), and hyponatremia (1.3% versus 0.7%).

从2项安慰剂对照研究的汇总数据来看，KERENDIA≥1%的患者报告的不良反应比安慰剂更常见的是高钾血症（14%对6.9%），低血压（4.6%对3.9%）和低钠血症（1.3%对0.7%）。

DRUG INTERACTIONS:

药物相互作用：

Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.

强CYP3A4抑制剂：禁忌同时使用KERENDIA和强CYP3A4抑制剂。避免同时摄入葡萄柚或葡萄柚汁。

Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor and adjust KERENDIA dosage as appropriate.

中度和弱CYP3A4抑制剂：在KERENDIA或中度或弱CYP3A4抑制剂的药物开始或剂量调整期间监测血钾，并酌情调整KERENDIA剂量。

Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers.

强和中度CYP3A4诱导剂：避免伴随使用强或中度CYP3A4诱导剂的KERENDIA。

USE IN SPECIFIC POPULATIONS:

在特定人群中使用：

Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment.

哺乳期：用KERENDIA治疗期间和治疗后1天避免母乳喂养。

Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B).

肝功能损害：避免在严重肝功能损害患者（Child-Pugh C）中使用KERENDIA，并考虑对中度肝功能损害进行额外的血钾监测（Child-Pugh B）。

Please read the Prescribing Information for KERENDIA.

请阅读KERENDIA的处方信息。

About Kerendia Phase III Clinical Trials Program2

关于Kerendia III期临床试验计划2

Having randomized more than 13,000 patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) around the world, the Phase III program with Kerendia in CKD associated with T2D comprises two studies, evaluating the effect of Kerendia versus placebo on top of standard of care (SoC) on both renal and cardiovascular (CV) outcomes..

在全球范围内随机分配了超过13000名与2型糖尿病（T2D）相关的慢性肾病（CKD）患者，与T2D相关的CKD中Kerendia的III期计划包括两项研究，评估Kerendia与安慰剂对肾脏和心血管（CV）结果的标准护理（SoC）。。

FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) and FIGARO-DKD (FInerenone in reducinG cArdiovascular moRtality and mOrbidity in Diabetic Kidney Disease) studies were randomized, double-blind, placebo-controlled, multicenter studies in adult patients with CKD associated with T2D.

FIDELIO-DKD（FInerenone减少糖尿病肾病的肾功能衰竭和疾病进展）和FIGARO-DKD（FInerenone降低糖尿病肾病的心血管死亡率和发病率）研究是随机，双盲，安慰剂对照，多中心研究成人CKD患者与T2D相关。

In FIDELIO-DKD, patients needed to either have an UACR of 30 to < 300 mg/g, eGFR 25 to < 60 mL/min/1.73 m2 and diabetic retinopathy, or an UACR of ≥ 300 mg/g and an eGFR of 25 to < 75 mL/min/1.73 m2 to qualify for enrollment. In FIGARO-DKD, patients needed to have an UACR of 30 mg/g to < 300 mg/g and an eGFR of 25 to 90 mL/min/1.73 m2, or an UACR ≥ 300 mg/g and an eGFR ≥ 60 mL/min/1.73 m2..

在FIDELIO-DKD中，患者需要UACR为30至<300 mg/g，eGFR 25至<60 mL/min/1.73 m2和糖尿病视网膜病变，或UACR≥300mg/g和eGFR为25至<75毫升/分钟/1.73平方米，以符合入学资格。在FIGARO-DKD中，患者需要UACR为30 mg/g至<300 mg/g，eGFR为25至90 mL/min/1.73 m2，或UACR≥300 mg/g且eGFR≥60 mL/min/1.73 m2。。

Both trials excluded patients with known significant non-diabetic kidney disease. All patients were to have a serum potassium ≤ 4.8 mEq/L at screening and be receiving SoC background therapy, including a maximum tolerated labeled dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).

两项试验均排除了已知显着的非糖尿病肾病患者。所有患者在筛查时血清钾≤4.8mEq/L，并接受SoC背景治疗，包括血管紧张素转换酶抑制剂（ACEi）或血管紧张素受体阻滞剂（ARB）的最大耐受标记剂量。

Patients with a clinical diagnosis of chronic heart failure (HF) with reduced ejection fraction and persistent symptoms (New York Heart Association class II to IV) were excluded. The starting dose of Kerendia® was based on screening eGFR (10 mg once daily in patients with an eGFR of 25 to < 60 mL/min/1.73 m2 and 20 mg once daily in patients with an eGFR ≥ 60 mL/min/1.73 m2).

临床诊断为慢性心力衰竭（HF）且射血分数降低和持续症状（纽约心脏协会II至IV级）的患者被排除在外。Kerendia®的起始剂量基于eGFR筛查（eGFR≥60mL/min/1.73 m2的患者每日一次10 mg，eGFR≥60mL/min/1.73 m2的患者每日一次20 mg））。

The dose of Kerendia could be titrated during the study, with a target dose of 20 mg daily..

在研究期间可以滴定Kerendia的剂量，目标剂量为每天20 mg。。

The primary objective of the FIDELIO-DKD study was to determine whether Kerendia reduced the incidence of a sustained decline in eGFR of ≥ 40%, kidney failure (defined as chronic dialysis, kidney transplantation, or a sustained decrease in eGFR to < 15 mL/min/1.73 m2), or renal death. The secondary outcome was a composite of time to first occurrence of CV death, non-fatal MI, non-fatal stroke or hospitalization for HF.

FIDELIO-DKD研究的主要目的是确定Kerendia是否将eGFR持续下降≥40%，肾功能衰竭（定义为慢性透析，肾移植或eGFR持续下降至<15 mL/min/1.73 m2）或肾脏死亡。次要终点是首次发生心血管死亡，非致命性心肌梗死，非致命性中风或HF住院的时间。

The primary objective of the FIGARO-DKD study was to determine whether Kerendia reduced the time to first occurrence of CV death, non-fatal MI, non-fatal stroke or hospitalization for HF. The secondary outcome was a composite of time to kidney failure, a sustained decline in eGFR of 40% or more compared to baseline over at least 4 weeks, or renal death..

FIGARO-DKD研究的主要目的是确定Kerendia是否减少首次发生心血管死亡，非致命性心肌梗死，非致命性卒中或HF住院的时间。次要结果是肾脏时间的综合与基线相比，失败，eGFR持续下降40%或更多，至少4周，或肾脏死亡。。

In FIDELIO-DKD, a total of 5,674 patients were randomized to receive Kerendia (N=2,833) or placebo (N=2,841) and were followed for a median of 2.6 years. The mean age of the study population was 66 years, and 70% of patients were male. This global trial population was 63% White, 25% Asian, and 5% Black (24% Black in the US).

在FIDELIO-DKD中，共有5674名患者被随机分配接受Kerendia（N=2833）或安慰剂（N=2841），随访时间中位数为2。6年。研究人群的平均年龄为66岁，70%的患者为男性。这个全球试验人群中白人占63%，亚洲人占25%，黑人占5%（美国黑人占24%）。

At baseline, the mean eGFR was 44 mL/min/1.73 m2, with 55% of patients having an eGFR < 45 mL/min/1.73 m2. Median urine albumin-to-creatinine ratio (UACR) was 852 mg/g, mean glycated hemoglobin A1c (HbA1c) was 7.7%, and the mean blood pressure was 138/76 mmHg. Approximately 46% of patients had a history of atherosclerotic CV disease and 8% had a history of HF.

在基线时，平均eGFR为44 mL/min/1.73 m2，55%的患者eGFR<45 mL/min/1.73 m2。中位尿白蛋白与肌酐比值（UACR）为852 mg/g，平均糖化血红蛋白A1c（HbA1c）为7.7%，平均血压为138/76 mmHg。大约46%的患者有动脉粥样硬化CV病史，8%有HF病史。

At baseline, 99.8% of patients were treated with an ACEi or ARB. Approximately 97% were on an antidiabetic agent (insulin [64.1%], biguanides [44%], glucagon-like peptide-1 [GLP-1] receptor agonists [7%], sodium-glucose cotransporter 2 [SGLT2] inhibitors [5%]), 74% were on a statin, and 57% were on an antiplatelet agent..

在基线时，99.8%的患者接受ACEi或ARB治疗。大约97%使用抗糖尿病药（胰岛素[64.1%]，双胍[44%]，胰高血糖素样肽-1[GLP-1]受体激动剂[7%]，钠-葡萄糖协同转运蛋白2[SGLT2]抑制剂[5%]），74%使用他汀类药物，57%使用抗血小板药物。。

In FIGARO-DKD, a total of 7,352 patients were randomized to receive Kerendia (N=3,686) or placebo (N=3,666) and were followed for 3.4 years. As compared to FIDELIO-DKD, baseline eGFR was higher in FIGARO-DKD (mean eGFR 68, with 62% of patients having an eGFR ≥ 60 mL/min/1.73 m2) and median UACR was lower (308 mg/g).

在FIGARO-DKD中，共有7352名患者被随机分配接受Kerendia（N=3686）或安慰剂（N=3666），随访3。4年。与FIDELIO-DKD相比，FIGARO-DKD的基线eGFR更高（平均eGFR 68,62%的患者eGFR≥60mL/min/1.73 m2），中位UACR更低（308 mg/g）。

Otherwise, baseline patient characteristics and background therapies were similar in the two trials..

否则，两项试验的基线患者特征和背景治疗相似。。

In FIDELIO-DKD, Kerendia reduced the incidence of the primary composite endpoint of a sustained decline in eGFR of ≥ 40%, kidney failure, or renal death (HR 0.82, 95% CI 0.73-0.93, P=0.001). The treatment effect reflected a reduction in a sustained decline in eGFR of ≥ 40% and progression to kidney failure.

在FIDELIO-DKD中，Kerendia降低了eGFR持续下降≥40%，肾功能衰竭或肾脏死亡的主要复合终点的发生率（HR 0.82,95%CI 0.73-0.93，P=0.001）。治疗效果反映eGFR持续下降≥40%并进展为肾功能衰竭。

There were few renal deaths during the trial. Kerendia also reduced the incidence of the secondary composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke or hospitalization for HF (HR 0.86, 95% CI 0.75-0.99, P=0.034). The treatment effect reflected a reduction in CV death, non-fatal MI, and hospitalization for HF.

试验期间肾脏死亡很少。Kerendia还降低了CV死亡，非致死性心肌梗死（MI），非致命性卒中或HF住院治疗的次要复合终点事件的发生率（HR 0.86,95%CI 0.75-0.99，P=0.034）。治疗效果反映了CV死亡，非致命性MI和HF住院治疗的减少。

The treatment effect on the primary and secondary composite endpoints was generally consistent across subgroups..

对主要和次要复合终点的治疗效果在各亚组之间基本一致。。

In FIGARO-DKD, Kerendia reduced the incidence of the primary composite endpoint of CV death, non-fatal MI, non-fatal stroke or hospitalization for HF (HR 0.87, 95% CI 0.76-0.98, P=0.026). The treatment effect was mainly driven by an effect on hospitalization for HF, though CV death also contributed to the treatment effect.

在FIGARO-DKD中，Kerendia降低了CV死亡，非致命性MI，非致命性卒中或HF住院的主要复合终点的发生率（HR 0.87,95%CI 0.76-0.98，P=0.026）。治疗效果主要是由于对HF住院的影响，尽管CV死亡也有助于治疗效果。

The treatment effect on the primary composite endpoint was generally consistent across subgroups, including patients with and without pre-existing cardiovascular disease. The secondary composite outcome of kidney failure, sustained eGFR decline of 40% or more or renal death occurred in 350 patients (9.5%) in the Kerendia group and in 395 (10.8%) in the placebo group (HR=0.87, 95% CI 0.76-1.01)..

主要复合终点的治疗效果在各亚组之间基本一致，包括有和没有预先存在的心血管疾病的患者。肾功能衰竭，eGFR持续下降40%或更多或肾脏死亡的次要复合终点发生在Kerendia组350例（9.5%）和安慰剂组395例（10.8%）（HR=0.87,95%）CI 0.76-1.01）。。

The safety of Kerendia was evaluated in 2 randomized, double-blind, placebo-controlled, multicenter pivotal phase 3 studies, FIDELIO-DKD and FIGARO-DKD, in which a total of 6,510 patients were treated with 10 or 20 mg once daily over a mean duration of 2.2 and 2.9 years, respectively. Overall, serious adverse events occurred in 32% of patients receiving Kerendia and in 34% of patients receiving placebo in the FIDELIO-DKD study; the findings were similar in the FIGARO-DKD study.

Kerendia的安全性在2项随机，双盲，安慰剂对照，多中心关键3期研究，FIDELIO-DKD和FIGARO-DKD中进行了评估，其中共有6510名患者每天一次接受10或20 mg治疗。平均持续时间分别为2。2年和2。9年。总体而言，在FIDELIO-DKD研究中，32%接受Kerendia的患者和34%接受安慰剂的患者发生严重不良事件；FIGARO-DKD研究的结果相似。

Permanent discontinuations due to adverse events also occurred in a similar proportion of patients in the two studies (6-7% of patients receiving Kerendia and in 5-6% of patients receiving placebo). From the pooled data of 2 placebo-controlled studies, the adverse reactions reported in ≥1% of patients on Kerendia and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3.9%), and hyponatremia (1.3% vs 0.7%).

在两项研究中，相似比例的患者（接受Kerendia治疗的患者为6-7%，接受安慰剂治疗的患者为5-6%）也出现因不良事件而永久停药的情况。从2项安慰剂对照研究的汇总数据来看，Kerendia≥1%且比安慰剂更频繁的不良反应报告为高钾血症（14%vs 6.9%），低血压（4.6%vs 3.9%）和低钠血症（1.3%对0.7%）。

The most frequently reported (≥ 10%) adverse reaction in both studies was hyperkalemia. Hospitalization due to hyperkalemia for the Kerendia group was 0.9% vs 0.2% in the placebo group across both studies. Hyperkalemia led to permanent discontinuation of treatment in 1.7% receiving Kerendia versus 0.6% of patients receiving placebo across both studies..

两项研究中最常报告的（≥10%）不良反应是高钾血症。在两项研究中，Kerendia组因高钾血症住院率为0.9%，安慰剂组为0.2%。在两项研究中，高钾血症导致1.7%接受Kerendia治疗的患者永久停药，而接受安慰剂治疗的患者为0.6%。。

About Chronic Kidney Disease Associated with Type 2 Diabetes

关于与2型糖尿病相关的慢性肾病

Patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) are three times more likely to die from a CV-related cause than those with T2D alone.5 CKD is a serious and progressive condition that is generally underrecognized.6 CKD is a frequent complication arising from T2D and is also an independent risk factor of CV disease.7,8,9 Approximately 40% of all patients with T2D develop CKD.7 Despite guideline-directed therapies, patients with CKD associated with T2D remain at high risk of CKD progression and CV events.5,6,10,11 T2D is the leading cause of end-stage kidney disease, which requires dialysis or a kidney transplant to stay alive.12,13,14.

与2型糖尿病（T2D）相关的慢性肾病（CKD）患者死于CV相关原因的可能性是单独使用T2D的患者的3倍[5]。CKD是一种严重的进行性疾病，通常未被认识到.6 CKD是由T2D引起的常见并发症，也是CV病的独立危险因素[7,8,9]。所有T2D患者中约有40%尽管有指南指导的治疗方法，但与T2D相关的CKD患者仍然存在CKD进展和CV事件的高风险.5,6,10,11 T2D是终末期肾病的主要原因，需要透析或肾移植来保持活力.12,13,14。

About Bayer’s Commitment in Cardiovascular and Kidney Diseases

关于拜耳在心血管和肾脏疾病方面的承诺

A leader in the cardiovascular (CV) space, Bayer upholds a long-standing commitment to delivering science for a better life by advancing research and treatment options.

拜耳作为心血管（CV）领域的领导者，通过推进研究和治疗方案，长期致力于为科学提供更好的生活。

Bayer’s cardiorenal franchise, which began with the discovery and development of a number of vital therapies, now includes a number of products and compounds in various stages of preclinical and clinical development with the potential to impact the way that CV and kidney diseases are treated.15

拜耳的心肾特许经营权始于发现和开发许多重要疗法，现在包括临床前和临床开发各个阶段的许多产品和化合物，可能会影响CV和肾脏疾病的治疗方式.15

Bayer is investigating in potential treatment approaches for areas of high unmet medical need. At present, Bayer is investigating 12 CVR-related projects through different stages of development including heart failure (HF), non-diabetic chronic kidney disease (CKD) and Type 1 Diabetes associated with chronic kidney disease.14.

拜耳正在研究针对高度未满足医疗需求领域的潜在治疗方法。目前，拜耳正在通过不同的发展阶段调查12个CVR相关项目，包括心力衰竭（HF），非糖尿病慢性肾病（CKD）和与慢性肾病相关的1型糖尿病。

Bayer is actively identifying resources and programs aimed at better understanding the real-world management of CKD, expanding screening and early care management for CKD, aligning with and supporting groups and institutions that share the common goals of improving health outcomes, promoting health literacy and education and promoting research and initiatives that represent the diversity required to address the needs of all patients.

拜耳正在积极确定旨在更好地了解CKD现实世界管理的资源和计划，扩大CKD的筛查和早期护理管理，与共同目标改善健康结果的团体和机构保持一致并提供支持，促进健康素养和教育，促进代表满足所有患者需求所需多样性的研究和举措。

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About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses.

拜耳是一家在医疗保健和营养生命科学领域拥有核心竞争力的全球企业。其产品和服务旨在通过支持努力掌握日益增长和老龄化的全球人口所带来的主要挑战，帮助人们和地球茁壮成长。拜耳致力于推动可持续发展并对其业务产生积极影响。

At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros.

与此同时，该集团旨在通过创新和增长提高其盈利能力和创造价值。拜耳品牌代表着全球的信任，可靠性和质量。在2022财年，该集团雇用约101000人，销售额为507亿欧元。特殊项目之前的研发费用为62亿欧元。

For more information, go to www.bayer.com..

欲了解更多信息，请访问www.bayer.com。。

Find more information at www.pharma.bayer.com

请访问www.pharma.bayer.com查找更多信息

Our online press service is just a click away: www.bayer.us/en/newsroom

我们的在线新闻服务只是一个点击：www.bayer.us/en/newsroom

Follow us on Facebook: http://www.facebook.com/pharma.bayer

Follow us on Facebook: http://www.facebook.com/pharma.bayer

Follow us on Twitter: https://twitter.com/BayerUS

在Twitter上关注我们：https://twitter.com/BayerUS

Forward-Looking Statements

前瞻性声明

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

本版本可能包含基于拜耳管理层当前假设和预测的前瞻性陈述。各种已知和未知的风险，不确定性和其他因素可能导致公司实际未来结果，财务状况，发展或业绩与此处给出的估计之间存在重大差异。

These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments..

这些因素包括拜耳公开报告中讨论的那些因素，这些报告可在拜耳网站www.Bayer.com上获得。本公司不承担任何更新这些前瞻性声明或使其符合未来事件或发展的责任。。

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1 Data on file.

1数据在文件中。

2 Data on file.

2数据在文件中。

3 Kerendia®: About Kerendia. Kerendia Patient. Accessed: 30 October 2023. Available at: https://www.kerendia-us.com/about-kerendia.

3 Kerendia®：关于Kerendia。Kerendia病人。访问时间：2023年10月30日。可在：https://www.kerendia-us.com/about-kerendia.

4 KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; September 2022.

4克伦迪亚（芬瑞酮）[处方信息]。新泽西州惠帕尼：Bayer HealthCare Pharmaceuticals，股份有限公司。；2022年9月。

5 Afkarian M, Sachs MC, Kestenbaum B, et al. Kidney disease and increased mortality risk in type 2 diabetes. J Am Soc Nephrol. 2013;24(2):302-308.

5 Afkarian M，Sachs MC，Kestenbaum B，et al.Kidney disease and increased mortality risk in type 2 diabetes。J Am Soc Nephrol。2013;24(2):302-308.

6 Breyer MD, Susztak K. Developing treatments for chronic kidney disease in the 21st century. Semin Nephrol. 2016;36(6):436-447.

6 Breyer MD，Susztak K.开发21世纪慢性肾病的治疗方法。Semin Nephrol。2016;36(6):436-447.

7 Anders HJ, Huber TB, Isermann B, et al. CKD in diabetes: diabetic kidney disease versus nondiabetic kidney disease. Nat Rev Nephrol. 2018;14:361-377.

7 Anders HJ，Huber TB，Isermann B，et al.CKD in diabetes:diabetic kidney disease versus nondiabetic kidney disease。Nat Rev Nephrol。2018;14:361-377.

8 Thomas MC, Brownlee M, Susztak K, et al. Diabetic kidney disease. Nat Rev Dis Primers. 2015;1:1-20.

8 Thomas MC，Brownlee M，Susztak K，et al。糖尿病肾病。Nat Rev Dis引物。2015;1:1-20.

9 Bailey RA, Wang Y, Zhu V, et al. Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging. BMC Res Notes. 2014;7(1):415. doi:10.1186/1756-0500-7-415.

9 Bailey RA，Wang Y，Zhu V，et al.Chronic kidney disease in US adults with type 2 diabetes:a new national estimation of prevalence based kidney disease:Improving Global Outcomes（KDIGO）staging。BMC Res Notes。2014;7（1）：415。doi:10.1186/1756-0500-7-415。

10 KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Int. 2013;3:1-150. https://kdigo.org/guidelines/ckd-evaluation-and-management.

10 KDIGO 2012慢性肾脏病评估和管理临床实践指南。Kidney Int。2013；3:1-150. https://kdigo.org/guidelines/ckd-evaluation-and-management.

11 American Diabetes Association. Standards of medical care in diabetes—2021. Diabetes Care. 2021;44(1):1-244.

11美国糖尿病协会。糖尿病医疗保健标准-2021。糖尿病护理。2021;44(1):1-244.

12 National Diabetes Statistics Report 2020: Estimates of Diabetes and Its Burden in the United States. Centers for Disease Control and Prevention. Accessed July 9, 2021. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.

12 2020年国家糖尿病统计报告：美国糖尿病及其负担的估计。疾病预防控制中心。访问于2021年7月9日。https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.

13 Stages of CKD. American Kidney Fund. Accessed May 11, 2021. https://www.kidneyfund.org/kidney-disease/chronic-kidney-disease-ckd/stages-of-chronic-kidney-disease.

CKD的13个阶段。美国肾脏基金会。访问于2021年5月11日。https://www.kidneyfund.org/kidney-disease/chronic-kidney-disease-ckd/stages-of-chronic-kidney-disease.

14 United States Renal Data System. USRDS Annual Data Report. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases; 2020. Accessed November 2021. https://adr.usrds.org/2020/chronic-kidney-disease/6-healthcare-expenditures-for-persons-with-ckd.

14美国肾脏数据系统。USRDS年度数据报告。国立卫生研究院，国立糖尿病，消化和肾脏疾病研究所；2020年。访问于2021年11月。https://adr.usrds.org/2020/chronic-kidney-disease/6-healthcare-expenditures-for-persons-with-ckd.

15 Data on file.

15文件中的数据。