Tirofiban

Acute coronary syndrome is a disease category with extremely high mortality and disability rates in the cardiovascular field, and excessive activation and aggregation of platelets are the core links in its pathological progression. Tirofiban, as a highly selective non-peptide platelet glycoprotein IIb/IIIa receptor antagonist, can potently inhibit platelet aggregation by blocking the binding of fibrinogen to platelet receptors. It is a commonly used clinical antithrombotic drug at present, mainly used for patients with unstable angina pectoris and non-ST-segment elevation myocardial infarction, and can also be used as an adjuvant during coronary interventional therapy to reduce the risk of perioperative thrombotic events. Its applicable population covers adult patients with acute coronary syndrome and subjects undergoing percutaneous coronary intervention.

At present, the global market size of tirofiban is about US$230 million, and the domestic market size is about RMB 1.2 billion. In recent years, with the increase in the penetration rate of primary coronary intervention diagnosis and treatment, the annual compound growth rate of the market has remained at around 8%. In terms of the competitive landscape, the market share of the original research product is less than 15%, and domestic generic drugs have occupied a dominant position. There are 17 domestic enterprises holding the approval documents of tirofiban preparations, and 7 enterprises have passed the consistency evaluation of generic drugs. The winning bid price in centralized procurement has a maximum decrease of more than 90% compared with the original research product, which significantly improves clinical accessibility.

The original research enterprise of tirofiban is Merck Sharp & Dohme, and the original trade name is Aggrastat. Its US compound patent expired in 2019, and its core Chinese patent expired in 2017. The main dosage forms approved for the original research product are injections, with specifications including 5mg/100ml and 12.5mg/250ml. The original research product has been included in the FDA Reference Listed Drug Catalog, and is also included in China's *Catalog of Reference Preparations for Chemical Drugs (9th Batch)*. In terms of domestic API registration, 11 enterprises including Qilu Pharmaceutical and Kelun Pharmaceutical have had their tirofiban APIs registered with the status of "A" approved by CDE. The preparations approved for marketing in China are mainly injections, and no oral dosage form has been approved yet. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of tirofiban impurity reference standards, which can fully cover the scenario requirements such as quality research, stability investigation and consistency evaluation of APIs and preparations. Most of the products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide reliable support for the quality control in the R&D and production links of pharmaceutical enterprises.