Probucol

Cardiovascular disease is one of the chronic diseases with the highest mortality rate in the world. Antioxidant and lipid-regulating therapy is the core solution to delay the progression of atherosclerosis. Probucol is an anti-atherosclerotic drug with dual effects of lipid regulation and antioxidation. By inhibiting the oxidative modification of low-density lipoprotein, promoting reverse cholesterol transport, scavenging oxygen free radicals and protecting vascular endothelial function, it is mainly used in the clinical treatment of hypercholesterolemia, and can also be used to prevent and treat atherosclerosis and the cardiovascular and cerebrovascular events caused by it such as coronary heart disease and cerebral infarction, especially suitable for patients with hypercholesterolemia who are intolerant to statins.

The global market size of probucol-related preparations was approximately USD 420 million in 2023, with a compound annual growth rate of 3.1% in the past five years. The growth momentum mainly comes from the continuous rise in the prevalence of cardiovascular and cerebrovascular diseases and the increasing demand for atherosclerosis intervention. The Chinese market is an important growth pole in the world, with a market size of approximately RMB 780 million in 2023. At present, the domestic preparation market is dominated by generic drugs, and probucol tablets from more than 10 enterprises have been approved for marketing. After the centralized procurement, the price of related dosage forms has dropped by more than 60%, which further drives the increase of clinical medication penetration rate, and the annual growth rate of upstream API demand remains at around 8%.

The original research enterprise of probucol is Otsuka Pharmaceutical of Japan, with the original brand name Lorelco. Its core compound patent expired in the 1990s, and there is no core patent restriction worldwide at present. The original dosage form is mainly tablets with a specification of 250mg, which has been included in the FDA Reference Listed Drug Catalog, and is also included in the Chinese Catalog of Reference Preparations for Chemical Drugs. In terms of domestic API registration, there are nearly 10 probucol API registration numbers at present, most of which are in status A (approved for use in marketed preparations). Domestic preparations have all realized localized supply of APIs, and there is no supply shortage. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for probucol API, which can perfectly meet the registration and declaration requirements of various regulatory markets. Most products are in stock, and orders placed before 16:00 can be delivered on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the whole process of R&D, production and quality control of API and preparation enterprises.