Fluticasone

The long-term control of chronic airway inflammatory diseases such as asthma and chronic obstructive pulmonary disease (COPD) has always been the core clinical demand in the respiratory field. As a representative variety of inhaled corticosteroids (ICS), fluticasone binds to intracellular glucocorticoid receptors to potently inhibit the release of inflammatory mediators and reduce airway hyperresponsiveness. Its local anti-inflammatory activity is hundreds of times that of dexamethasone, and the incidence of systemic adverse reactions is much lower than that of systemic hormones. At present, this ingredient has become the first-line drug for long-term control of asthma recommended by major guidelines. It can also be combined with long-acting β2 receptor agonists to form a compound preparation for maintenance treatment of patients with moderate to severe COPD, covering the full age group of patients with chronic respiratory diseases from children to adults.

The global market size of fluticasone-related preparations has exceeded 6 billion US dollars. With the annual increase in the global prevalence of asthma and the popularization of early COPD screening, the compound annual growth rate has maintained at 4.2% in the past three years. Driven by the volume-based procurement policy in the domestic market, the accessibility of inhaled preparations has been greatly improved. In 2023, the sales volume of fluticasone-related preparations in public medical institutions exceeded 2.8 billion yuan, and the market share of generic drugs has increased from 12% in 2020 to 47% in 2023. The competitive pattern between original research drugs and generic drugs is being gradually restructured, and the demand for upstream API has continued to rise accordingly.

The original research enterprise of fluticasone is GlaxoSmithKline (GSK), and the original research trade name is Flixotide (fluticasone propionate inhalation aerosol). Its core compound patent expired globally in 2011. At present, the main dosage forms of the original research products on the market include inhalation aerosol, nasal spray and cream. The common specifications of inhalation aerosol are 50μg, 125μg and 250μg per actuation, and the relevant reference preparations have been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China and the FDA reference preparation catalogue. Up to now, more than 10 domestic enterprises have obtained CDE registration for fluticasone propionate API, and a total of 21 fluticasone propionate-related preparation varieties have been approved for marketing, covering multiple administration routes such as inhalation, nasal use and external use. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for fluticasone API. Most of the products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the impurity reference standard needs of pharmaceutical enterprises in all links such as API R&D, quality research and consistency evaluation, so as to efficiently facilitate the compliant declaration of products.