On March 4, Kelun Pharmaceutical issued an announcement stating that the "Drug Supplementary Application Approval Notice" for the chemical drug "Tirofiban Hydrochloride Sodium Chloride Injection" recently approved and issued by the National Medical Products Administration.
Pass the quality and efficacy consistency evaluation of generic drugs.
100ml: tirofiban hydrochloride (calculated as C22H36N2O5S) 5mg and sodium chloride 0.
250ml: tirofiban hydrochloride (calculated as C22H36N2O5S) 12.
5mg and sodium chloride 2.
This product is mainly used for adult patients with non-ST-elevation acute coronary syndrome with ECG changes and/or myocardial enzyme elevation within 12 hours of the last chest pain onset, to prevent early myocardial infarction; and to plan direct PCI ( Percutaneous coronary intervention) in patients with acute myocardial infarction to reduce the occurrence of major cardiovascular events.
Tirofiban is a platelet glycoprotein IIb/IIIa receptor antagonist.
It has the advantages of rapid onset, definite efficacy, and rapid recovery of platelet function after drug withdrawal.
It has been approved by the European "Guidelines for Myocardial Revascularization (2018)" , China's "Acute ST-segment elevation myocardial infarction diagnosis and treatment guidelines (2019)", China's "Acute ST-segment elevation myocardial infarction rational use of thrombolytic therapy guidelines (2019)" and other domestic and foreign authoritative guidelines recommended for use.
Tirofiban Hydrochloride Sodium Chloride Injection is a category B product of the National Medical Insurance in 2020, and its sales in China in 2019 are about 190 million yuan.