Cangrelor

In the antithrombotic clinical pathway for acute coronary syndrome and percutaneous coronary intervention (PCI), cangrelor, as the first intravenously administered P2Y12 receptor antagonist, fills the clinical gap of oral antiplatelet drugs which have slow onset of action and long metabolic cycle. It does not require metabolic activation by the liver, and the peak platelet inhibition can be reached within 2 minutes after administration, while platelet function recovers within 1 hour after drug discontinuation. It is especially suitable for patients requiring emergency PCI, with high bleeding risk or intolerant to oral antithrombotic drugs, and can significantly reduce the risk of adverse cardiovascular events such as perioperative myocardial infarction and in-stent thrombosis.

The current global market size of cangrelor is approximately USD 180 million, and the compound annual growth rate from 2023 to 2028 is expected to remain at around 7.2%. The growth momentum mainly comes from the continuous increase in the volume of PCI procedures and the release of demand for precise perioperative antithrombotic therapy. The domestic market is still in the early stage of development. Due to the late expiration date of the original research patent, the generic drug layout of domestic enterprises is still in the clinical declaration stage at present, and no domestic preparation has been approved for marketing, so the market is temporarily monopolized by the original research product.

The original research enterprise of cangrelor is The Medicines Company in the United States, and the original research trade name is Kengreal. Its core compound patent in the United States expires in 2029, and the compound patent in China expires in 2030. The main dosage form approved for the original research is injection, with a specification of 50mg per vial. It has been included in the FDA Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Preparations for Chemical Drugs (10th Batch)*. Up to now, there is no cangrelor API registered with A status in China. Only the original research imported cangrelor for injection was approved for marketing in China in 2021. (Data as of September 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of cangrelor impurity reference standards, most of which are in stock. Orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the reference standard use needs of the whole process of API R&D, quality research and declaration.