Eptifibatide

Thrombotic events during acute coronary syndrome and percutaneous coronary intervention (PCI) are major clinical challenges in the cardiovascular field, and antiplatelet therapy is the core regimen for the management of such diseases. Eptifibatide is an antithrombotic active pharmaceutical ingredient (API) belonging to the category of platelet glycoprotein Ⅱb/Ⅲa receptor antagonists. It reversibly blocks the binding of fibrinogen to the Ⅱb/Ⅲa receptors on the surface of activated platelets, thereby inhibiting the final common pathway of platelet aggregation. It is clinically used for patients with acute coronary syndrome and patients receiving PCI treatment, and can significantly reduce the risk of ischemic events such as myocardial infarction and target vessel revascularization, especially suitable for the population with cardiovascular diseases at high risk of thrombosis.

At present, the global market size of eptifibatide is approximately USD 320 million. Driven by the steady growth of PCI procedure volume and the improvement of primary cardiovascular diagnosis and treatment capacity, the compound annual growth rate (CAGR) in the past five years has maintained at around 4.7%. The growth rate of the Chinese market is higher than the global average, with a CAGR of 7.2%, and the overall domestic market size exceeded RMB 420 million in 2023. In terms of competitive landscape, the original research product still accounts for about 30% of the high-end medical market. Domestic generic preparations have passed the consistency evaluation, have obvious price advantages, and are gradually penetrating into the primary market. At present, there are 7 registered API manufacturers in China, and the competition on the supply side is relatively sufficient.

The original research enterprise of eptifibatide is Merck Sharp & Dohme (MSD), with the original brand name Integrilin (Aibeixin). Its core compound patent in the United States expired in 2019, and the compound patent in China expired in 2020. The main dosage form approved for the original product is injection, with specifications of 20mg/10ml and 75mg/100ml. It has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. At present, there are 11 domestic registration numbers of eptifibatide APIs, 8 of which are in Status A and can be legally supplied to preparation manufacturers. In addition, eptifibatide injections from 6 enterprises 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 eptifibatide impurity reference standards to meet the quality control requirements of the whole process of R&D and production. Most products are available in stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, helping enterprises efficiently promote the R&D and declaration of related preparations.