Pemafibrate

Cardiovascular disease is the leading cause of death globally, among which dyslipidemia is an important controllable risk factor. As one of the core options for lipid-lowering therapy, fibrate drugs have made breakthroughs in precision research and development in recent years. Pemafibrate is a selective agonist of peroxisome proliferator-activated receptor α (PPARα). Compared with traditional fibrate drugs, it has stronger targeting to PPARα, which can effectively reduce triglycerides and increase high-density lipoprotein cholesterol, while reducing the risk of liver and kidney-related adverse reactions. It is clinically mainly used for the treatment of hypertriglyceridemia, and can also be combined with statins for lipid control in patients with mixed dyslipidemia, especially suitable for adult patients with poor tolerance to traditional fibrates.

The huge base of patients with dyslipidemia worldwide drives the continuous expansion of the pemafibrate-related market. Currently, the global market size has exceeded 1.2 billion US dollars, with a compound annual growth rate maintained at around 18%. As the original research patents have recently expired intensively, the generic drug market is in a stage of rapid expansion. Three enterprises in the United States and India have obtained approval for the marketing of generic drugs. At present, no generic drug has been approved in China, and more than 10 pharmaceutical enterprises are carrying out bioequivalence trials. The market demand for active pharmaceutical ingredients (APIs) and related supporting reagents is continuing to rise.

The original research enterprise of pemafibrate is Kowa Co., Ltd. of Japan, with the original research trade name Parmodia. Its core compound patent expires in September 2024 in China, and the core patent for the US market expires in March 2025. The main dosage form approved for the original research product is tablet, with specifications including 0.25 mg and 0.5 mg, which has been included in the Japanese Orange Book and the FDA Reference Listed Drug Catalog. Up to now, no pemafibrate API has been approved for marketing in China, and there is no relevant valid registration number on the CDE API registration platform. Only the original research imported pemafibrate tablets were approved for marketing in China in 2023, which is the only marketed preparation product in China at present. (Data as of October 2024, please refer to the official CDE website for the latest information)

In response to the impurity research needs in the process of pemafibrate generic drug research and development and quality control, CATO provides a full set of impurity reference standards for this API. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. They fully meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can effectively help R&D enterprises shorten the impurity research cycle and reduce compliance risks.