Hybutimibe

As the first domestically independently developed novel cholesterol absorption inhibitor, hybutimibe belongs to the selective NPC1L1 receptor antagonist class of lipid-regulating drugs. Its mechanism of action is different from that of traditional statins. It can specifically block the NPC1L1 receptor on the brush border membrane of the small intestine, inhibit the intestinal absorption of cholesterol from food and bile, reduce the cholesterol storage in the liver, and thereby lower the cholesterol level in the blood circulation. Clinically, it is mainly used for the treatment of primary hypercholesterolemia, and can be used alone or in combination with statins. It is especially suitable for patients who are intolerant to statins or fail to meet the blood lipid control target with statins alone. At present, it has been included as a recommended drug in multiple clinical guidelines for the management of dyslipidemia.

The prevalence of dyslipidemia in China has exceeded 40%, with the number of patients surpassing 300 million, and the market size of lipid-regulating drugs continues to expand. According to public data, the market size of domestic cholesterol absorption inhibitor drugs exceeded 3 billion yuan in 2023. As the first domestically developed variety, hybutimibe has maintained a market growth rate of over 80% since its launch, and its sales in sample hospitals exceeded 700 million yuan in 2023. At present, only the original research enterprise holds the preparation approval for this variety. With the advancement of generic drug R&D, there is considerable domestic substitution space in both the API and preparation markets in the future.

Hybutimibe is independently developed by Zhejiang Hisun Pharmaceutical Co., Ltd., with the trade name "Saisimei". Its core compound patent was applied for in 2008 and will expire in 2028. The currently approved main dosage form is tablet, with specifications including 10mg and 20mg, which has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration. In terms of domestic API registration, Hisun Pharmaceutical's hybutimibe API has completed registration with the CDE with the status of A, which can be legally supplied for preparation production and use. At present, multiple domestic enterprises have started the R&D and declaration work of generic drugs for this variety. (Data as of April 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of hybutimibe impurity reference standards. All products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and the FDA. Most products are in regular stock. Orders placed before 16:00 can be shipped on the same day, which can fully meet the needs of various R&D and production scenarios such as impurity research, quality control, and generic drug consistency evaluation.