China-based C.Q. Pharmaceutical Holding Co., Ltd (SHE: 000950) announced that its clinical application for prasugrel has been accepted for review by the National Medical Products Administration (NMPA).
Drug Background
Prasugrel, originated by Japan’s Daiichi Sankyo Co., Ltd. (trade name: Effient), was licensed to C.Q. Pharma, granting it exclusive rights in China. It is a third-generation P2Y12 receptor antagonist indicated for patients with coronary artery disease undergoing elective percutaneous coronary intervention. The drug helps prevent acute coronary syndrome, stable angina pectoris, and thrombosis in myocardial infarction patients.
Global and Domestic Status
While prasugrel is not yet available in China, it has gained approval in over 70 global markets. C.Q. Pharma initially filed for marketing approval in August 2021 but withdrew the application in July 2023 to submit additional documentation.-Fineline Info & Tech
