Pardoprunox

Chronic kidney disease-related hyperkalemia is a difficulty in long-term clinical management. Traditional potassium-lowering drugs have limitations such as slow onset of action and poor compliance, and the advent of patiromer provides a better treatment option for such patients. As a novel oral potassium binder, its mechanism of action is to selectively bind potassium ions in the gastrointestinal tract, reduce the absorption of potassium by the intestine, and thereby lower serum potassium concentration. Compared with traditional drugs, patiromer has a faster onset of action and fewer adverse reactions, and can maintain stable blood potassium levels for a long time. It is mainly used for the treatment of hyperkalemia in adults, especially suitable for patient groups requiring long-term blood potassium control, such as those with chronic kidney disease and heart failure.

At present, the scale of the global hyperkalemia treatment market continues to expand. As a core innovative variety launched in recent years, the global sales of patiromer exceeded US$1.2 billion in 2023, with an annual growth rate stable at around 28%. In terms of the domestic market, with the growth of the chronic kidney disease patient base and the increase in clinical attention to hyperkalemia, the clinical dosage of patiromer has been increasing year by year. At present, no generic drug of this variety has been approved in the domestic market, and the original research product occupies the entire market share, leaving a large potential space for generic drug substitution.

The original research enterprise of patiromer is AstraZeneca, and the original trade name is Lokelma (利倍卓). Its core compound patent will expire in China in 2031. The dosage form of the original research product approved in China is dry suspension, with a specification of 5g per bag, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* issued by the National Medical Products Administration. Up to now, there is no approved registration number for this variety on the CDE API registration platform. Only the original research dry suspension preparation has been approved for marketing in China, and no domestic generic drug preparation has been approved for the time being. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for patiromer, most of which are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. The relevant products all meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of pharmaceutical enterprises in the whole process of R&D, quality control, etc.