Indacaterol

Chronic obstructive pulmonary disease (COPD), a highly prevalent chronic respiratory disease, has long imposed severe impacts on patients' quality of life, and long-acting β₂-adrenoceptor agonists are among the core medications for the long-term maintenance treatment of this disease. Indacaterol belongs to the class of long-acting β₂-adrenoceptor agonist (LABA) drugs. It can selectively activate β₂ receptors on airway smooth muscle to relax airway smooth muscle and dilate bronchi, with a duration of action of up to 24 hours. It is mainly indicated for the maintenance treatment of chronic obstructive pulmonary disease (including chronic bronchitis and emphysema) in adults, and can effectively relieve the symptoms of airflow limitation in patients and reduce the risk of acute exacerbations. Compared with traditional short-acting preparations, it greatly improves medication compliance.

Currently, the global number of people suffering from COPD has exceeded 300 million, and the market demand for corresponding long-acting bronchodilators continues to rise. The global market size of indacaterol has stabilized at around USD 2.5 billion in recent years, with compound preparations contributing more than 80% of the market share. In terms of the domestic market, with the improvement of the diagnosis and treatment rate of COPD and the expansion of medical insurance coverage, the annual compound growth rate of the market for indacaterol-related preparations has remained above 18% in the past three years. At present, the original research products still occupy the major market share in China, and a number of local pharmaceutical companies have arranged for the research and development of generic drugs. The accessibility of relevant varieties will be further improved after the implementation of centralized procurement.

The original research enterprise of indacaterol is Novartis Pharma, with the original research brand name of "Onbrez". Its core compound patent expired in China in 2021. The main dosage form approved for the original research product is powder for inhalation, with a specification of 150 μg per actuation. It has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also listed in the FDA Reference Preparations Catalogue. In terms of domestic API registration, a number of enterprises have submitted DMF registration numbers for indacaterol API, some of which are already in "A" status (marketable). A number of preparations including the original research product and various domestic generic drugs have been approved for marketing in China. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for indacaterol, which can meet the qualitative and quantitative requirements of impurities in different R&D stages. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and provide stable support for the R&D and quality control links of pharmaceutical enterprises.