Ezetimibe

In the prevention and control of cardiovascular diseases, hypercholesterolemia is the core risk factor inducing atherosclerosis, myocardial infarction and cerebral infarction. Ezetimibe is currently the only approved intestinal cholesterol absorption inhibitor type of lipid-regulating drug. Different from the mechanism of statins which inhibit hepatic cholesterol synthesis, it acts by targeted blocking of the NPC1L1 transporter on the brush border of the small intestine to reduce the intestinal absorption of cholesterol from food and bile. It can be used alone in patients intolerant to statins, or used in combination with statins and PCSK9 inhibitors to realize multi-pathway regulation of cholesterol, covering populations with primary hypercholesterolemia in adults, homozygous familial hypercholesterolemia and others, and is a key medication in the stepwise treatment of dyslipidemia.

At present, the global market size of ezetimibe API has exceeded 1.2 billion US dollars, with a compound annual growth rate of 7.2% in the recent 3 years. In the domestic market, following the upgrade of the recommendation level for combined medication in blood lipid management guidelines, and the substantial improvement of the accessibility of primary care medications after the implementation of the third and fifth batches of national centralized drug procurement, the domestic sales volume of ezetimibe preparations increased by 41% year on year in 2023, which directly drives the rapid expansion of API demand. In terms of the competitive landscape, after the expiration of the original research patent, more than 20 domestic enterprises have obtained the approval documents for ezetimibe API, with production capacity mainly concentrated in East China and South China, and the industry's compliance demand for qualitative and quantitative research on impurities continues to rise.

CATO can provide a full set of impurity reference standards for ezetimibe API. All products meet the dual regulatory compliance requirements of the Chinese Pharmacopoeia and FDA, and are supported by structure confirmation reports and complete traceability materials. The spot coverage rate of core impurities exceeds 95%, which can greatly shorten the quality research cycle of API and preparation enterprises and reduce the risk of registration and declaration.