Umeclidinium

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease with a high disability rate, and bronchodilators are the core medication option in its long-term management. Umeclidinium bromide belongs to long-acting muscarinic antagonists (LAMA). It competitively blocks M3 receptors on airway smooth muscle, relaxes bronchial smooth muscle, and continuously improves airway ventilation. It is clinically mainly used for the long-term maintenance treatment of adult COPD patients, including symptom relief for patients with chronic bronchitis and emphysema. It can effectively reduce the risk of acute exacerbations and improve patients' exercise tolerance and quality of life. Its 24-hour long-acting property significantly reduces the frequency of daily medication for patients and improves long-term medication compliance.

At present, the number of COPD patients worldwide exceeds 300 million, and the number of domestic patients is close to 100 million, driving the continuous expansion of the long-acting bronchodilator market. Relevant data show that the domestic market size of compound preparations related to umeclidinium bromide exceeded 1.8 billion yuan in 2023, with a compound annual growth rate of 22% in the past 3 years. Currently, the domestic market is still dominated by original research products, and only 3 local enterprises have been approved for generic umeclidinium bromide preparations. With the continuous release of drug demand in the respiratory field and the coverage of centralized procurement policies for drugs for rare diseases and chronic diseases, the domestic substitution space for umeclidinium bromide APIs and preparations is gradually expanding.

The original research enterprise of umeclidinium bromide is GlaxoSmithKline (GSK), and the original trade name is Anoro Ellipta (umeclidinium bromide and vilanterol trifenatate powder for inhalation). The expiration date of its core compound patent in China is 2026. The main dosage form approved for the original research is powder for inhalation, with the specification of umeclidinium bromide 62.5μg/vilanterol 25μg, which has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China. Up to now, 3 enterprises have submitted registration of umeclidinium bromide APIs on the CDE API registration platform, among which 1 has been approved for joint evaluation with preparations. A number of single-agent and compound preparations of umeclidinium bromide have been approved for marketing in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of umeclidinium bromide impurity reference standards. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can provide stable reference material support for API R&D, quality research and preparation consistency evaluation.