Finerenone

As the most common microvascular complication of type 2 diabetes mellitus, chronic kidney disease has long faced the clinical pain point of limited treatment options. It was not until the advent of non-steroidal highly selective mineralocorticoid receptor antagonists that a new path was provided for patients to delay disease progression. Finerenone can precisely block the inflammation and fibrosis damage caused by excessive activation of mineralocorticoid receptors. It neither affects the homeostasis of blood glucose and serum potassium, nor fills the treatment gap that cannot be covered by traditional RAS inhibitors. Currently, it has been approved for reducing the risks of glomerular filtration rate decline, end-stage renal disease, cardiovascular death, and heart failure hospitalization in patients with type 2 diabetes-related chronic kidney disease, and its applicable population covers patients with type 2 diabetic kidney disease in the whole course of disease from early stage to middle and late stages.

After finerenone entered the Chinese market in 2022, its clinical recognition has increased rapidly. In 2023, its sales in domestic sample hospitals have exceeded 280 million yuan, with a compound growth rate of more than 370% in the past three years. At present, the global market is still dominated by the original research enterprise, and more than 15 domestic pharmaceutical companies have laid out the research and development of generic drugs, among which 3 companies' generic drugs were approved for marketing in 2024. As the core patent expires in 2026, the demand in the API market will further expand, and there is no public statistical data on the overall industry capacity.

CATO can provide a full set of impurity reference standards for finerenone API. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. The in-stock inventory covers the needs of the whole stage from R&D to mass production, which can directly help pharmaceutical companies shorten the impurity research cycle and accelerate the declaration progress.