Finerenone

Chronic kidney disease, as one of the most common microvascular complications of type 2 diabetes, has affected more than 160 million patients worldwide. For a long time, traditional treatment regimens have the limitation of high residual cardiovascular risk. Finerenone, as the first approved non-steroidal highly selective mineralocorticoid receptor antagonist for this population, can accurately block the inflammatory and fibrotic pathological processes induced by over-activation of mineralocorticoid receptors. It can not only reduce the risks of sustained eGFR decline and end-stage renal disease in patients with type 2 diabetes-related chronic kidney disease, but also decrease the occurrence of adverse events such as cardiovascular death and non-fatal myocardial infarction, filling the clinical gap of simultaneous renal and cardiac dual benefits in this therapeutic field.

At present, the global market size of finerenone has exceeded 1.6 billion US dollars, with a compound annual growth rate of over 80% from 2021 to 2024, and it is in a rapid volume expansion stage. Since its approval for marketing in the domestic market in 2022, the market growth rate has remained above 150% for three years. The original research product still occupies more than 90% of the market share, and no generic drug has been approved yet. By the end of 2024, more than 30 domestic pharmaceutical enterprises have submitted applications for the declaration of active pharmaceutical ingredients (APIs) or preparations. As the core patents are approaching expiration, the launch of generic drugs in the next 3-5 years will rapidly promote the market to sink to primary medical institutions, and the overall market size is expected to exceed 3 billion yuan.

The original research enterprise of finerenone is Bayer AG from Germany, and the original brand name is Kerendia®. Its core compound patent in China will expire in October 2026, and the preparation patent will expire in 2033. At present, the original formulation approved in China is tablet, with specifications of 10mg and 20mg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs (49th Batch)* issued by the National Medical Products Administration. In terms of API registration, the API of the original research Bayer has completed registration with the Center for Drug Evaluation (CDE) (registration number Y20210000295) with the status of A. By the end of 2024, 12 domestic enterprises have submitted marketing registration applications for finerenone APIs, which have not been approved yet; in terms of preparations, in addition to the original research product, 17 enterprises have submitted generic drug marketing applications, which are under the review and approval stage. (Data as of June 2025, please refer to the official website of CDE for the latest information)

In response to the demand for impurity research in the development process of finerenone generic drugs, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully support the quality research, registration and declaration and other related work of pharmaceutical enterprises.