美氟尼酮

As a chronic disease with high incidence globally, chronic kidney disease has long lacked precise intervention methods targeting the renal fibrosis process. The advent of meflunidone has filled this clinical gap. As a novel oral small-molecule anti-fibrotic drug, meflunidone is a non-steroidal mineralocorticoid receptor antagonist. It can block the over-activation of mineralocorticoid receptors with high selectivity, inhibit inflammatory response and extracellular matrix deposition, and delay the progression of renal fibrosis. Currently, it is mainly used to treat renal injuries associated with chronic kidney diseases such as IgA nephropathy and diabetic nephropathy, providing a brand-new treatment option for chronic kidney disease patients who have been facing the risk of renal function deterioration for a long time.

The global base of chronic kidney disease patients exceeds 800 million, and the market demand for anti-renal fibrosis drugs continues to expand. As the first domestically developed innovative small-molecule drug in this field, meflunidone's sales in the first year after its domestic launch in 2023 exceeded 200 million yuan, and its sales in the first half of 2024 reached 320 million yuan. It is expected that the compound annual growth rate will remain above 65% in the next three years. At present, only the preparation products of the original research enterprise are on the domestic market, and the supply of active pharmaceutical ingredients (APIs) has not been liberalized. In addition, the drug has been included in the 2024 version of the National Medical Insurance Catalogue, the accessibility for patients has been rapidly improved, the willingness of generic drug enterprises to layout continues to rise, and the demand for upstream APIs and supporting impurity reference substances is in a period of rapid growth.

The original research enterprise of meflunidone is Chengdu Shengnuo Biopharmaceutical Co., Ltd., with the original trade name "Sheng Nuoda". Its core compound patent will expire in 2040. The domestically approved preparation dosage form is tablet, with a specification of 10mg, which has been included in the *Catalogue of Chemical Reference Preparations (76th Batch)* issued by the National Medical Products Administration. Up to now, no meflunidone APIs from other domestic enterprises have been approved for marketing. The CDE API Registration Platform only shows 1 valid registration number (Registration No.: Y20220000348) of the original research enterprise, with the status of A, which can be used for associated preparation declaration. The only domestically approved preparation on the market is the meflunidone tablet of the original research enterprise. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of meflunidone impurity reference standards, covering all categories such as process impurities and degradation impurities, which can meet the full-process research requirements including synthetic process development, quality research, stability study, etc. Most impurity products are supplied from stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can directly support the declaration needs in multiple regions such as China, the United States and Europe, providing reliable reference substance support for the meflunidone-related R&D and production work of pharmaceutical enterprises.