Imrecoxib

Osteoarthritis is a chronic degenerative disease with a high incidence among the middle-aged and elderly population. For a long time, clinical treatment has relied on non-steroidal anti-inflammatory drugs, but traditional drugs are often associated with the risk of gastrointestinal adverse reactions. Imrecoxib is a highly selective cyclooxygenase-2 (COX-2) inhibitor independently developed in China. By specifically blocking the synthesis of prostaglandins mediated by COX-2, it exerts anti-inflammatory and analgesic effects while greatly reducing the damage to the gastrointestinal mucosa. It is mainly used to relieve symptoms such as joint pain and swelling caused by osteoarthritis, and its applicable population covers patients with mild to moderate osteoarthritis, especially the middle-aged and elderly groups who need long-term medication and have poor gastrointestinal tolerance.

The domestic patient base of osteoarthritis has exceeded 100 million, driving the continuous expansion of the imrecoxib-related market, with an annual compound market growth rate of around 12% in the past three years. At present, the competitive landscape of this variety is concentrated, and the original research product occupies the core market share. With the advancement of generic drug research and development, generic preparations from 3 enterprises have passed the consistency evaluation. After entering the centralized procurement catalog, the terminal price has dropped by more than 60%, which further improves clinical accessibility and also drives the continuous rise in demand for upstream API.

The original research enterprise of imrecoxib is Jiangsu Hengrui Pharmaceutical Co., Ltd., and the original research trade name is "Hengyang". The core compound patent expired in 2023. At present, the main dosage form approved in China is tablet, with a conventional specification of 0.1g. The original research preparation has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration. In terms of API registration, there are currently 6 imrecoxib API registration information on the CDE platform, of which 3 are in status A (approved for use in marketed preparations). A total of 5 domestic enterprises have obtained marketing approval for imrecoxib tablets. (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 imrecoxib API, covering a full series of research reference materials such as production process impurities and degradation impurities. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully meet the use needs of pharmaceutical enterprises in various scenarios such as quality research and consistency evaluation.