Bayer’s Kerendia® (finerenone) wins NMPA approval in China for heart failure with LVEF ≥40%, expanding use beyond CKD and supported by pivotal FINEARTS‑HF trial data.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Bayer has secured a significant cardiovascular label expansion in China, with the National Medical Products Administration (NMPA) approving Kerendia® (finerenone) for adults with symptomatic chronic heart failure and left ventricular ejection fraction (LVEF) ≥40%. The decision extends use beyond chronic kidney disease (CKD) associated with type 2 diabetes to include both heart failure with mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF).
Addressing a High‑Burden Population
The approval positions finerenone among the limited therapies authorized for HF patients with preserved or mildly reduced ejection fraction a group representing nearly half of all heart failure cases. These patients face high rates of hospitalization and cardiovascular mortality, often compounded by comorbidities such as CKD, diabetes, hypertension, and atrial fibrillation. In China, heart failure prevalence exceeds 10 million, underscoring the scale of unmet need in the LVEF ≥40% population.
Mechanism of Action
Finerenone is a non‑steroidal, selective mineralocorticoid receptor antagonist (nsMRA) that blocks receptor overactivation, a driver of inflammation, fibrosis, cardiovascular remodeling, and kidney damage. By targeting this pathway, Bayer has positioned Kerendia as a cardiorenal therapy platform spanning both heart failure and CKD populations.
Evidence from FINEARTS‑HF
The Chinese approval was supported by the pivotal Phase 3 FINEARTS‑HF trial (NCT04435626), a randomized, double‑blind, placebo‑controlled study enrolling nearly 6,000 patients across 37 countries. Finerenone, added to standard therapy, significantly reduced the composite of cardiovascular death and total heart failure events including first and recurrent hospitalizations and urgent visits — compared with placebo. Benefits were consistent across subgroups, including patients on SGLT2 inhibitors and those with varying ejection fractions.
Safety outcomes were in line with the established profile, with hyperkalemia manageable through monitoring. Investigators noted the therapy’s tolerability across diverse patient populations.
Expert and Executive Commentary
Professor Ma Changsheng, principal investigator for FINEARTS‑HF in China, said finerenone addresses a major disease mechanism in heart failure and could improve outcomes in a clinically vulnerable population with multiple comorbidities.
Bayer executive Christine Roth highlighted the consistency of data generated across five Phase 3 studies involving more than 20,000 patients with heart failure or CKD.
Global Strategy and Pipeline
The approval further expands Bayer’s global heart failure strategy. Finerenone is already approved for HF with LVEF ≥40% in the United States, European Union, Japan, and several additional markets, with regulatory reviews ongoing elsewhere.
Bayer continues to advance the broader MOONRAKER heart failure development program and the FINEOVATE clinical platform, which together include multiple ongoing Phase 3 studies across adult and pediatric cardiorenal populations.
Reference
Kerendia™ approved in China for new indication in adult patients with heart failure with LVEF ≥40%
About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.