Hainan Shuangcheng’s Generic Eptifibatide Gains TGA Marketing Approval in Australia

Hainan Shuangcheng's Generic Eptifibatide Gains TGA Marketing Approval in Australia

China’s Hainan Shuangcheng Pharmaceutical Co., Ltd (SHE: 002693) has received marketing approval from Australia’s Therapeutic Goods Administration (TGA) for its generic version of eptifibatide. Originally marketed by Schering Corp under the brand name Integrilin, the drug is indicated for patients undergoing elective percutaneous coronary intervention (PCI) and coronary stent implantation, as well as for the treatment of unstable angina or non-ST-segment elevation myocardial infarction (NSTEMI).

Eptifibatide Mechanism and Indications
Eptifibatide is a synthetic platelet glycoprotein IIb/IIIa (GPIIb/IIIa) receptor antagonist. It selectively binds to GPIIb/IIIa receptors, blocking fibrinogen and von Willebrand factor from binding to these receptors. This action inhibits platelet aggregation and prevents arterial reocclusion. Integrilin was first approved in the US in May 1998 and was initially marketed by Schering. Following the acquisition by Merck Sharp & Dohme (MSD), the drug is now globally available.

Shuangcheng’s Generic Version
Shuangcheng Pharmaceutical’s generic version of eptifibatide gained US FDA approval in 2021. The recent TGA approval in Australia further expands the availability of this important medication, offering more options for patients and healthcare providers.-Fineline Info & Tech