Beclometasone

Glucocorticoids are the core clinically used drugs for controlling chronic airway inflammation. As a classic inhaled glucocorticoid, beclomethasone binds to intracellular glucocorticoid receptors to inhibit the synthesis and release of inflammatory mediators, while reducing airway hyperresponsiveness. Compared with systemic hormones, its local anti-inflammatory effect is 500 times that of cortisone, and the incidence of systemic adverse reactions is significantly reduced. It has now become a first-line drug for the long-term maintenance treatment of bronchial asthma, and can also be used for the treatment of chronic obstructive pulmonary disease, allergic rhinitis and a variety of skin inflammatory diseases, covering all age groups including adults and children.

The global market size of inhaled glucocorticoids has exceeded 12 billion US dollars, of which beclomethasone-related preparations account for approximately 18%, with a compound annual growth rate maintained at 4.2%. In the domestic market, driven by the rising prevalence of asthma year by year and the centralized procurement policy, the market growth rate of beclomethasone preparations has remained above 8% in the past 3 years. Three rounds of national centralized procurement have been completed so far, with an average price reduction of 72% for winning bids. The market share of domestic generic preparations has increased from 23% in 2020 to 61% in 2023, and the demand for APIs continues to release along with the generic drug substitution process.

The original developer of beclomethasone is GlaxoSmithKline, with the original brand name "Becotide". Its core compound patent expired globally in 1999, and the core formulation patent for inhalation aerosol expired in 2010. The originally approved dosage forms mainly include inhalation aerosol, nasal spray and cream. The inhalation aerosol has specifications of 50μg/puff and 250μg/puff, which have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA Reference Preparation Catalogue. As of now, there are 12 registration entries of beclomethasone APIs on China's CDE API Registration Platform, among which 7 have obtained A status through associated review with preparations, and 24 beclomethasone-related preparation varieties have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of beclomethasone impurity reference standards. Most of the products are in sufficient stock. Orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple national regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the needs of the entire process of API R&D, quality research and registration declaration.