Corticosterone

In the clinical treatment of adrenocortical insufficiency, physiological glucocorticoid supplementation is the core regimen. As a typical representative of endogenous adrenocortical hormones, corticosterone plays an irreplaceable role in this regimen. It belongs to natural glucocorticoid drugs. By binding to glucocorticoid receptors, it can regulate the metabolism of sugar, protein and fat, and exert multiple pharmacological effects such as anti-inflammation, immunosuppression and anti-stress at the same time. Clinically, it is mainly used for the replacement treatment of primary/secondary adrenocortical insufficiency, and can also be partially used for short-term symptomatic intervention of autoimmune diseases such as rheumatoid arthritis and bronchial asthma as well as allergic diseases. Its applicable population covers patients of all age groups from children to the elderly with related diseases, and it is a basic clinical drug in the fields of endocrinology and immunology.

The global market size of corticosterone preparations has maintained steady growth in recent years. In 2023, the market size was approximately USD 320 million, with a compound annual growth rate maintained at around 4.1%. The growth momentum mainly comes from the increased diagnosis rate of chronic adrenal diseases and the expansion of the patient population with autoimmune diseases. The current market pattern is characterized by "original research leading, generic drugs supplementing". European and American enterprises account for more than 65% of the market share. Most domestic generic drug enterprises mainly focus on the supply of API, and the preparation end is still in the stage of gradual import substitution. In terms of the domestic market, as the coverage of volume-based procurement extends to drugs for rare diseases, the procurement price of corticosterone-related preparations has dropped by approximately 42% compared with the previous level, and the accessibility for patients has been significantly improved.

The original research enterprise of corticosterone is Pfizer, and the original trade name is Cortone. Its compound patent in the United States expired in 2005, and the core preparation patent in China expired in 2008. The main dosage form approved for the original research product is tablet, with specifications including 5mg, 10mg and 20mg. It has been included in the FDA Orange Book Reference Listed Drug Catalog, but has not yet been included in the China Listed Drug Catalog. As of October 2024, the registration platform of the Center for Drug Evaluation (CDE) of China has included a total of 3 valid registration numbers for corticosterone API, among which 1 has obtained A status through the joint evaluation and approval with preparations, and 2 domestic enterprises have obtained marketing approval for corticosterone tablets. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for corticosterone API. The products fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most of the products are in regular stock, and orders placed before 16:00 can be delivered on the same day. It can fully meet the reference standard supply needs of pharmaceutical enterprises in the whole process of R&D, quality control, etc., and help enterprises accelerate the registration, declaration and production implementation of related products.