Polmacoxib

Perioperative pain management is a core link in reducing postoperative complications and improving the efficiency of patient rehabilitation. As a highly selective cyclooxygenase-2 (COX-2) inhibitor non-steroidal anti-inflammatory drug, parecoxib specifically blocks COX-2 mediated prostaglandin synthesis, exerting potent analgesic and anti-inflammatory effects while significantly reducing adverse reactions of traditional non-steroidal anti-inflammatory drugs such as gastrointestinal injury and bleeding. It is clinically mainly used for short-term treatment of moderate to severe postoperative pain. It can be used alone for analgesia in small and medium-sized surgeries, or combined with opioids for analgesia in major surgeries to help reduce the dosage of opioids. It is suitable for adult patients aged 18 and above who require postoperative analgesia.

With the continuous expansion of the postoperative analgesia market, the proportion of selective COX-2 inhibitors has been increasing year by year by virtue of their safety advantages. At present, the overall market size of parecoxib in China has exceeded 1.2 billion yuan, with a compound annual growth rate of around 18% in the past 3 years. In terms of the competitive landscape, the original research product still accounts for about 41% of the market share. Generic preparations from 6 domestic enterprises have been approved for marketing and passed the consistency evaluation, among which 3 have been included in the national centralized procurement, with the highest price reduction of the winning bid reaching 89% compared with the original research product. With the implementation of centralized procurement, there is still room for further improvement in market penetration.

The original research enterprise of parecoxib is Pfizer, and the original research trade name is "Dynastat". Its Chinese compound patent expired in 2022. The currently approved main dosage form is injection, with a specification of 40mg per vial. The original research product has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the National Medical Products Administration, and is also listed as an FDA reference preparation. In terms of API registration, there are currently 7 parecoxib API registration entries on the CDE platform including Pfizer's, among which 5 are declared by domestic enterprises and 3 have been marked with the status of "A", which can be used in association with domestic preparation declarations. In China, 7 enterprises have obtained marketing approval for parecoxib for injection preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of parecoxib impurity reference standards. Most products are in stock. In-stock products ordered before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for the R&D and quality control links of API and preparation enterprises.