Bayer Submits New Drug Application in China to Expand Finerenone Use for Adults with Non-Diabetic Chronic Kidney Disease
Bayer has announced the submission of a New Drug Application (NDA) to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), seeking approval to expand the approved indication of finerenone to include adult patients with non-diabetic chronic kidney disease (CKD). If approved, the expanded indication would significantly broaden access to the medicine for patients whose kidney disease is not associated with diabetes, addressing a major unmet medical need in one of the world’s largest CKD patient populations.
The regulatory filing is supported by positive findings from the Phase III FIND-CKD clinical trial, which demonstrated that finerenone significantly reduced the risk of kidney disease progression and cardiovascular complications in adults with non-diabetic CKD. Results from the landmark study were presented during the European Renal Association (ERA) Congress 2026 and simultaneously published in the New England Journal of Medicine, highlighting the growing body of evidence supporting finerenone’s role in protecting both kidney and cardiovascular health.
The submission represents another important milestone in Bayer’s strategy to expand the therapeutic applications of finerenone beyond diabetic kidney disease and reinforce its position in the treatment of chronic kidney and cardiovascular disorders.
Expanding Treatment Options for Non-Diabetic CKD
Chronic kidney disease remains one of the fastest-growing causes of illness and death worldwide, affecting an estimated 850 million people globally. While diabetes is widely recognized as a leading cause of CKD, more than half of all patients with chronic kidney disease do not have diabetes, leaving a substantial population with limited treatment options.
Patients with non-diabetic CKD frequently experience progressive loss of kidney function despite receiving current standard therapies, including blood pressure control and renin-angiotensin system inhibitors. As kidney function deteriorates, many patients eventually develop kidney failure requiring dialysis or kidney transplantation.
Worldwide, more than 3.5 million people currently receive dialysis treatment for kidney failure. Although dialysis can sustain life, it is associated with considerable physical, emotional, and financial burdens. Long-term outcomes also remain poor, with approximately 40% five-year survival following initiation of dialysis therapy.
Because of these challenges, there is an urgent need for treatments capable of slowing kidney disease progression before patients reach end-stage kidney disease.
Non-Diabetic CKD Includes Multiple Underlying Diseases
Unlike diabetic kidney disease, non-diabetic CKD encompasses a broad range of underlying conditions that damage the kidneys over time.
Among the most common causes are:
- Chronic kidney disease associated with hypertension
- Glomerulonephritis
- IgA nephropathy (IgAN)
- Focal segmental glomerulosclerosis (FSGS)
- Other chronic inflammatory and structural kidney disorders
Hypertension-related kidney disease represents the second leading cause of kidney failure worldwide. Persistent high blood pressure gradually damages the kidney’s filtering units, reducing renal function over many years.
Similarly, glomerular diseases such as IgA nephropathy and FSGS cause inflammation and scarring of the kidneys, frequently leading to progressive kidney impairment despite available therapies.
Regardless of the underlying cause, patients with non-diabetic CKD remain vulnerable to ongoing kidney damage and serious cardiovascular complications.
Cardiovascular Risk Remains a Major Concern
Chronic kidney disease affects much more than kidney function alone.
Individuals with advanced CKD face a substantially elevated risk of cardiovascular disease, including:
- Heart attack
- Stroke
- Heart failure
- Cardiovascular death
Research has shown that patients with advanced non-diabetic CKD have approximately 2.6 times greater risk of fatal cardiovascular events compared with individuals without chronic kidney disease.
The cardiovascular risk continues to increase as kidney function declines, creating a close relationship between kidney disease progression and worsening heart health.
For this reason, therapies capable of protecting both the kidneys and cardiovascular system are considered particularly valuable for CKD management.
FIND-CKD Trial Supports Expanded Indication
Bayer’s regulatory submission is based on data generated from the international Phase III FIND-CKD clinical trial.
The study evaluated finerenone in adults with chronic kidney disease unrelated to diabetes across multiple underlying disease causes.
The trial investigated whether treatment with finerenone could reduce the risk of:
- Kidney disease progression
- Declining kidney function
- Kidney failure
- Cardiovascular complications
According to Bayer, the study produced positive results, demonstrating meaningful clinical benefits across a broad spectrum of non-diabetic CKD etiologies.
Importantly, the trial included patients with:
- Hypertension-associated CKD
- Various glomerular diseases
- Other non-diabetic causes of chronic kidney disease
These findings expand the evidence supporting finerenone beyond its previously established role in diabetic kidney disease.
The publication of the findings in the New England Journal of Medicine further underscores the scientific significance of the study and its potential impact on clinical practice.
Bayer Highlights Growing Evidence for Finerenone
Dr. Christian Rommel, Global Head of Research and Development for Bayer’s Pharmaceuticals Division, emphasized the importance of the FIND-CKD results in expanding treatment opportunities for patients living with chronic kidney disease.
He noted that individuals with non-diabetic CKD continue to face substantial risks of progressive kidney function decline and cardiovascular events despite existing standards of care.
According to Dr. Rommel, the Phase III FIND-CKD study provides robust clinical evidence demonstrating the potential benefits of finerenone across a diverse range of non-diabetic kidney diseases, including hypertension-related kidney disease and several glomerular disorders.
He explained that the latest regulatory submission builds upon the extensive clinical development program for finerenone and represents another important step toward making the therapy available to more patients worldwide.
Dr. Rommel added that Bayer remains committed to advancing innovative therapies that improve outcomes for people living with heart and kidney diseases through continued research and global regulatory efforts.
Finerenone’s Established Clinical Role
Finerenone is a selective non-steroidal mineralocorticoid receptor antagonist (MRA) designed to reduce inflammation and fibrosis affecting both the kidneys and cardiovascular system.
Unlike older steroidal MRAs, finerenone was specifically developed to provide targeted mineralocorticoid receptor blockade with a favorable balance between efficacy and safety.
Since its initial approval in 2021, finerenone has been marketed under the brand names:
- Kerendia™
- Firialta™ (in selected countries)
The medicine is currently approved in more than 100 countries, including:
- China
- United States
- European Union
- Japan
- Numerous additional global markets
Its primary approved indication has been the treatment of adults with chronic kidney disease associated with type 2 diabetes, where it has demonstrated the ability to slow kidney disease progression while reducing cardiovascular risk.
Additional Cardiovascular Indications
Beyond chronic kidney disease associated with diabetes, finerenone has continued expanding into cardiovascular medicine.
The therapy is currently approved in several major markets—including the United States, European Union, Japan, and China—for the treatment of heart failure with left ventricular ejection fraction (LVEF) of 40% or greater.
Additional regulatory applications for this indication remain under review in other countries.
These expanding approvals reflect Bayer’s strategy of positioning finerenone as a therapy capable of addressing interconnected heart and kidney diseases, an area increasingly recognized as requiring integrated treatment approaches.
Potential Impact in China
China faces one of the world’s largest burdens of chronic kidney disease, driven by aging populations, hypertension, diabetes, and other chronic illnesses.
Expanding finerenone’s indication to include non-diabetic CKD could provide physicians with a new therapeutic option for a broad patient population that currently has limited disease-modifying treatments available.
If approved by the National Medical Products Administration, finerenone would become one of the few therapies specifically supported by Phase III evidence for reducing kidney disease progression and cardiovascular risk across diverse forms of non-diabetic chronic kidney disease.
The application also reflects Bayer’s broader commitment to improving access to innovative therapies in China while addressing the growing global burden of chronic kidney disease.
About Kerendia™ / Firialta™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway that in five pivotal Phase III studies has demonstrated cardiovascular and/or kidney benefits across a broad range of patient populations, including patients with HF with left ventricular ejection fraction (LVEF) ≥40%, patients with CKD associated with type 2 diabetes, patients with CKD associated with type 1 diabetes, and patients with non-diabetic CKD.
Finerenone is a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA) that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.
The clinical study program with finerenone, FINEOVATE, currently comprises twelve Phase III studies with dedicated programs in CKD and HF respectively. The THUNDERBALL CKD program consists of the completed Phase III studies FIDELIO-DKD, FIGARO-DKD, FIND-CKD, and FINE-ONE, and the Phase II study CONFIDENCE; as well as the ongoing Phase III studies in pediatric patient populations FIONA, and FIONA-OLE. The MOONRAKER program includes the completed pivotal Phase III study FINEARTS-HF, the ongoing investigator-sponsored, collaborative studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF, as well as the ongoing Phase III studies in pediatric patient populations, FIORE and FIORELLO.
About FIND-CKD
FIND-CKD is the largest Phase III study to date focused on non-diabetic CKD. The study investigated finerenone in a broad patient population spanning different etiologies of non-diabetic CKD, adding to the positive data and breadth of evidence of finerenone in CKD associated with diabetes. FIND-CKD (FInerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease) investigated the efficacy and safety of finerenone compared to placebo in addition to standard of care in more than 1,500 patients with non-diabetic chronic kidney disease etiologies, including kidney disease linked to hypertension and glomerular diseases.
Patients were randomized to receive either finerenone 10mg or 20mg or placebo on top of maximum tolerated labeled doses of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB).
In the FIND-CKD study, finerenone showed a statistically significant and clinically meaningful improvement of kidney function compared with placebo: The mean annual decline in eGFR from baseline to 32 months (total slope) was −4.0 ml/minute/1.73 m2/year with placebo and −3.3 ml/minute/1.73 m2/year with finerenone, corresponding to a 0.7 ml/minute/1.73 m2/year slower decline with finerenone [95% CI, 0.3-1.1; p<0.001]).
Finerenone also significantly reduced the risk of the key secondary composite cardiovascular-kidney outcome, by 23% (HR 0.77 [95% CI, 0.60-0.99; p=0.04]). The result for the secondary endpoints of the composite of sustained ≥57% eGFR decline or kidney failure was HR 0.78 (95% CI, 0.60-1.01; p=0.06), and the composite of hospitalization for heart failure or cardiovascular death was HR 0.60 (95% CI, 0.27-1.33).
Finerenone was well-tolerated in the FIND-CKD study, which is consistent with the well-established safety profile of finerenone.
About Chronic Kidney Disease
Chronic kidney disease (CKD) is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. Chronic Kidney Disease (CKD) represents a major global health challenge, affecting 850 million people worldwide – in fact, as the ninth leading cause of death, it results in 1.5 million fatalities each year, translating to one death every 20 seconds.
In the U.S., 1 in 3 adults is at risk for the disease. At advanced stages of CKD, patients may need dialysis or a kidney transplant to stay alive. Healthy kidneys act as the body’s filter, removing waste products from the blood. They also control how much water and electrolytes are in the body, regulating blood pressure.
As kidney function goes down, patients may experience a range of symptoms including leg swelling, tiredness in the day, nausea, muscle cramps, joint pain and confusion, trouble focusing, memory problems. Major underlying causes of CKD include diabetes, hypertension, and glomerular diseases such as immunoglobulin A nephropathy, focal segmental glomerulosclerosis and membranous nephropathy.
About Bayer’s Commitment in Cardiovascular and Kidney Diseases
Bayer is a leader in the area of cardiology and is advancing a portfolio of innovative treatments. The heart and the kidneys are closely linked in health and disease, and Bayer is working on new treatment approaches for cardiovascular and kidney diseases with high unmet medical needs.
The strategy is to unlock the strong potential of the future cardiovascular market by transforming Bayer’s portfolio into precision cardiology, addressing the high disease burden, and driving long-term growth. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular and kidney diseases are treated.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s 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. 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 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros.