米拉贝隆

Overactive bladder is a chronic urinary system disease with a high incidence among middle-aged and elderly populations. For a long time, the core treatment regimen has been M receptor antagonists, but such drugs often bring anticholinergic side effects such as dry mouth and constipation, resulting in low patient compliance. Mirabegron is the first globally approved highly selective β3 adrenoceptor agonist. It acts on the β3 receptors of the bladder detrusor muscle to relax the detrusor and increase the bladder's urine storage capacity. While relieving symptoms such as frequent urination, urgent urination and urge urinary incontinence, it avoids the adverse reactions of traditional anticholinergic drugs, and is especially suitable for elderly patients who cannot tolerate the side effects of M receptor antagonists and special populations with comorbid glaucoma and prostatic hyperplasia.

Since its launch, the global market size of mirabegron has grown steadily. In 2023, its global sales exceeded 2.2 billion US dollars, and the compound annual growth rate in the Chinese market in the past five years has reached 32%. At present, the mirabegron preparations marketed in China are mainly the original research product and 3 domestic generic versions. In the 9th batch of national centralized drug procurement in 2023, the average price reduction of the winning bids for mirabegron sustained-release tablets reached 71%. With the implementation of the centralized procurement, the volume expansion of the downstream preparation market has driven the continuous rise in demand for API. At present, the domestic supply of mirabegron API is still dominated by the original research supporting supply and a small number of domestic manufacturers, and the market gap is gradually expanding.

The original research enterprise of mirabegron is Astellas Pharma, with the trade name Betmiga. Its core compound patent will expire in China in March 2024, and the crystal form patent will expire in 2033. The main dosage form approved by the original research is sustained-release tablets, with two specifications of 25mg and 50mg, which have been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and the FDA reference preparation catalogue. As of the time of retrieval, the CDE API Registration Platform has included a total of 7 mirabegron API registration entries, among which 3 have been registered with A status. A number of domestic enterprises have obtained marketing approval for mirabegron sustained-release tablets. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for mirabegron API. Most products are in stock. In-stock products ordered before 16:00 will be shipped on the same day. They can meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and provide stable reference material support for API R&D, quality research and consistency evaluation work.