On May 21, 2026, German pharmaceutical company Bayer announced that its innovative drug Finerenone (Kerendia) has been officially approved by the China National Medical Products Administration (NMPA) for use in adult patients with heart failure and a left ventricular ejection fraction (LVEF) ≥40%.

This approval means that Finerenone has formally entered the treatment landscape for heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF), with the potential to reduce:

• Cardiovascular death risk
• Heart failure hospitalization risk
• Emergency visits due to heart failure

This represents a significant recent advancement in the field of heart failure treatment. China pharmaceutical wholesaler DengYueMed will continue to monitor important therapeutic developments in cardiovascular, renal, and metabolic diseases.

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What is Finerenone?

Finerenone is a highly selective, non-steroidal mineralocorticoid receptor antagonist (MRA).

Compared with traditional steroidal MRAs, Finerenone has more precise receptor binding properties and acts on aldosterone-mediated inflammatory and fibrotic pathways, thereby:

• Reducing myocardial fibrosis
• Inhibiting cardiac remodeling
• Reducing renal injury
• Improving the progression of cardiorenal metabolic diseases

Previously, Finerenone had already been approved in China for:

• Type 2 diabetes-associated chronic kidney disease (CKD)

This new heart failure indication further strengthens its position in the integrated “cardio-renal-metabolic” disease management landscape.

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FINEARTS-HF Study: A Landmark Positive Trial in Non-steroidal MRA in Nearly 20 Years

The approval in China was primarily based on the global Phase III pivotal study: FINEARTS-HF.

This study enrolled more than 6,000 patients with LVEF ≥40% heart failure, with a median follow-up of 32 months.

1. 16% Reduction in Primary Composite Endpoint

Finerenone group:

• 3,003 patients
• 624 patients experienced 1,083 primary endpoint events

Placebo group:

• 2,998 patients
• 719 patients experienced 1,283 primary endpoint events

Results:

• Hazard ratio (HR) = 0.84
• 95% CI: 0.74–0.95
• P = 0.007

This indicates that Finerenone significantly reduced the composite risk of total heart failure events and cardiovascular death by 16%.

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2. 18% Reduction in Total Heart Failure Events

In the study:

• Finerenone group: 842 worsening heart failure events
• Placebo group: 1,024 events

Results:

• HR = 0.82
• 95% CI: 0.71–0.94
• P = 0.006

This shows that Finerenone significantly reduced:

• Heart failure hospitalization
• Acute decompensation
• Emergency medical visits

Overall, total heart failure events were reduced by 18%.

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3. Cardiovascular Mortality

Cardiovascular death rates in the two groups were:

• Finerenone group: 8.1%
• Placebo group: 8.7%

Results:

• HR = 0.93
• 95% CI: 0.78–1.11

Although numerically lower, the difference did not reach statistical significance.

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Safety Profile of Finerenone

Overall, the safety profile of Finerenone was consistent with previous studies.

1. Serious Adverse Events

• Finerenone group: 38.7%
• Placebo group: 40.5%

Overall incidence of serious adverse events was comparable between the two groups.

2. Hyperkalemia Risk Requires Attention

As an MRA-class drug, hyperkalemia remains an important safety concern.

Study data showed:

Serum potassium > 6.0 mmol/L

• Finerenone group: 3.0%
• Placebo group: 1.4%

Hyperkalemia-related hospitalization

• Finerenone group: 0.5%
• Placebo group: 0.2%

Additionally:

• Higher incidence of increased creatinine levels
• Lower incidence of hypokalemia

Therefore, in clinical use:

• Regular monitoring of serum potassium is required
• Renal function should be assessed
• Attention should be paid to drug interactions

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Why is HFpEF Treatment So Important?

For a long time, treatment options for heart failure with preserved ejection fraction (HFpEF) have been limited.

Compared with heart failure with reduced ejection fraction (HFrEF), HFpEF is characterized by:

• More complex pathophysiology
• Older patient population
• Frequent comorbidities such as diabetes, kidney disease, and hypertension

For many years, there have been few therapies with clear clinical benefit in HFpEF.

In recent years:

• SGLT2 inhibitors
• Non-steroidal MRAs
• Novel cardiorenal-metabolic therapies

have gradually changed the HFpEF treatment landscape.

The approval of Finerenone in China means that patients with HFpEF now have a new treatment option.

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Clinical Significance of Finerenone Approval

From a global cardiovascular perspective, this approval carries multiple implications.

1. Strengthening the Cardio-Renal-Metabolic Treatment Paradigm

Modern chronic disease management is shifting from single-organ treatment toward integrated management of:

• Heart
• Kidneys
• Metabolism

Finerenone represents a key example of this trend.

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2. Non-steroidal MRAs Enter Mainstream Heart Failure Therapy

Traditional steroidal MRAs are effective but limited by:

• Hyperkalemia risk
• Hormone-related side effects

Finerenone, as a non-steroidal MRA, provides a new therapeutic pathway.

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3. Expansion of the HFpEF Treatment Market in China

With population aging and increasing metabolic diseases, the number of HFpEF patients in China continues to grow.

Following this approval:

• Treatment options will be further expanded
• Precision heart failure management will accelerate
• Demand for integrated cardio-renal care will continue to increase

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Conclusion

Finerenone has been approved in China for adult heart failure patients with LVEF ≥40%, marking an important advancement in the HFpEF treatment landscape.

Key study findings show:

• 18% reduction in total heart failure events
• 16% reduction in primary composite endpoint risk
• Overall manageable safety profile

Although hyperkalemia requires careful monitoring, its therapeutic value in cardiorenal-metabolic diseases continues to expand.

As heart failure treatment continues to move toward precision medicine, long-term management, and integrated cardio-renal care, more innovative therapies are entering clinical practice.

DengYueMed continues to monitor developments in cardiovascular, renal, and rare disease therapies, as well as global pharmaceutical supply trends, providing international clients with pharmaceutical sourcing, supply chain, and cross-border drug information support services.

👉 On the same day, Johnson & Johnson’s nipocalimab was also approved for marketing in China. Please refer to the article for details: Nipocalimab Approved in China for Generalized Myasthenia Gravis, With Long-Term Stable Disease Control Emerging as a Key Highlight