Fenofibrate

Dyslipidemia is a core risk factor for cardiovascular diseases such as atherosclerosis and coronary heart disease. As the first-line treatment option for hypertriglyceridemia, fibrate drugs occupy an irreplaceable clinical position in lipid management. Fenofibrate, as a second-generation phenoxyfibric acid lipid-regulating drug, regulates the expression of enzymes related to lipoprotein metabolism by activating peroxisome proliferator-activated receptor α (PPARα). It can not only significantly reduce the levels of serum triglyceride and very low-density lipoprotein, but also moderately increase the concentration of high-density lipoprotein cholesterol. Clinically, it is mainly used to treat adult patients with hypercholesterolemia and hypertriglyceridemia who have poor response to diet control therapy, especially suitable for patients with mixed dyslipidemia. It can also be used in combination with statins for the comprehensive lipid management of people at high cardiovascular risk.

The global market size of fenofibrate is stably above 2 billion US dollars. With the continuous rise in the prevalence of dyslipidemia, the compound growth rate in the past three years has remained at around 4.2%. In terms of the domestic market, fenofibrate is a variety included in the National Essential Medicine List, and has also been included in multiple batches of the national centralized procurement catalog. The winning bid price has dropped by about 65% compared with before, driving the rapid growth of clinical usage. In 2023, the terminal sales of domestic public medical institutions exceeded 1.2 billion yuan. At present, the domestic fenofibrate preparation market is dominated by generic drugs, with more than 15 enterprises having passed the consistency evaluation. The API supply side presents a pattern of parallel domestic and imported manufacturers, and the localization rate is increasing year by year.

The original developer of fenofibrate is Laboratoires Fournier S.A. in France, with the original brand name Lipanthyl®. Its core compound patent expired globally in 2008. The main dosage forms approved for the original drug include 200mg micronized capsules, 160mg tablets and 145mg supermicronized tablets. Among them, the 200mg micronized capsules and 160mg tablets have been included in the China Listed Medicines Catalog as reference preparations, and are also included in the FDA Reference Preparations List. Up to now, there are more than 30 fenofibrate API registration records on the API registration platform of China Center for Drug Evaluation (CDE), of which 18 are in status A and can be legally supplied for domestic preparation production. There are more than 60 domestic fenofibrate preparation approvals, covering multiple dosage forms such as tablets, capsules and granules. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of fenofibrate impurity reference standards, which fully cover process impurities, degradation impurities and specific impurities. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products have sufficient stock reserves, and orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard requirements in the process of API R&D, quality research and production.