Bivalirudin

As a representative anticoagulant drug of direct thrombin inhibitors, bivalirudin can reversibly bind to the catalytic site and the anion binding exosite of thrombin, block fibrinogen lysis and platelet aggregation, exert a dose-dependent anticoagulant effect, and is not affected by heparin-induced thrombocytopenia (HIT). It is clinically mainly used for perioperative anticoagulation in percutaneous coronary intervention (PCI), and is also applicable to patients with acute coronary syndrome and high-risk thrombosis receiving hemodialysis, especially suitable for the population with cardiovascular diseases who have contraindications to heparin, and can significantly reduce the risk of perioperative bleeding events.

In 2023, the global bivalirudin market size was approximately USD 320 million, with the Chinese market accounting for 27%, and the compound annual growth rate in the recent 3 years has maintained at 8.1%. The growth momentum mainly comes from the continuous increase in the volume of PCI surgeries. In the domestic market, 8 enterprises have obtained preparation approvals, and 3 enterprises have passed the consistency evaluation of generic drugs. After the centralized procurement, the winning bid price has dropped by more than 85% compared with the original research drug, the clinical accessibility has been greatly improved, and the utilization rate in primary medical institutions has increased year by year.

The original research enterprise of bivalirudin is a Swiss pharmaceutical company, and the original research brand name is Angiomax. Its core compound patent in the United States expired in 2010, and its preparation patent in China expired in 2019. The dosage form approved for the original research drug is injection, with a specification of 250 mg per vial, which has been included in the *Catalogue of Chemical Reference Preparations* of China and the FDA reference preparation catalogue. Up to now, there are 11 bivalirudin registration entries on the API registration platform of China Center for Drug Evaluation (CDE), of which 7 are in status A and can be used for associated review. A number of generic preparation varieties 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 can provide a full set of impurity reference standards for bivalirudin, most of which are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products fully comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the reference standard requirements in the whole process of API research and development, quality research and registration declaration.