Procaterol

Bronchial asthma is a chronic airway inflammatory disease. For a long time, the core clinical treatment regimen is glucocorticoid combined with bronchodilator, and the emergence of highly selective β₂ receptor agonists provides a more accurate option for the long-term control of mild to moderate asthma. Procaterol is a third-generation β₂ adrenoceptor agonist. It acts by highly selectively activating β₂ receptors on airway smooth muscles, relaxing bronchial smooth muscles, inhibiting the release of inflammatory mediators from mast cells and other cells, and meanwhile promoting the ciliary movement of the airway and enhancing mucociliary clearance. Its bronchodilating effect can last for more than 12 hours, and it is suitable for relieving wheezing symptoms in patients with bronchial asthma, asthmatic bronchitis, acute bronchitis with increased bronchial reactivity, and chronic obstructive pulmonary disease, especially for people who need long-term control of nocturnal asthma attacks.

At present, the number of asthma patients worldwide exceeds 300 million, and the prevalence of asthma among Chinese adults reaches 4.2%, corresponding to the continuous expansion of the market size of asthma-related drugs, among which β₂ receptor agonists account for about 18% of the market share of asthma treatment drugs. As a representative variety of long-acting highly selective β₂ agonists, procaterol has maintained an annual domestic market sales in the range of 1.2 to 1.5 billion yuan in recent years, with a compound annual growth rate of around 6%. In terms of competitive landscape, the domestic preparation market is dominated by the original research product and 2 to 3 leading generic drug enterprises. The domestic substitution rate of API supply has exceeded 70% at present, and only a small number of high-end preparations still use imported APIs.

The original research enterprise of procaterol is Otsuka Pharmaceutical of Japan, with the original research trade name of "Meptin". Its core compound patent expired in 2005 in Japan and major European and American markets, and the compound patent in China expired in 2006. At present, the dosage forms approved by the original research in China include tablets and oral solutions. The specifications of tablets are 25μg and 50μg, and the specification of oral solution is 0.0005% (30ml:0.15mg). Relevant dosage forms have been included in the China List of Marketed Drugs as reference preparations. As of now, there are 12 registration entries of procaterol APIs on the CDE API registration platform, including 9 domestic registration numbers and 3 import registration numbers, 8 of which have a registration status of A, which can be used for associated domestic preparation declaration and marketing. The domestically approved procaterol preparation varieties cover three categories: tablets, oral solutions and granules. (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 procaterol API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. They fully comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully support the full-process requirements of API R&D, quality research and compliance declaration.