热博RB88

2021-02-18

Wanbang Biopharma Ticagrelor Tablets and Apixaban Tablets Approved for Marketing

Recently, Jiangsu Wanbang Biopharmaceuticals Co., Ltd. ("Wanbang Biopharma") received marketing approval for Ticagrelor Tablets (Wansujie®) and Apixaban Tablets (Keyue®) from NMPA. The marketing of these two products will help solve more anti-thrombotic needs in clinical practice, benefit more patients, and enrich the product pipeline layout and enhance the product power of Wanbang Biopharma.



Wansujie® (Ticagrelor Tablets) is a new antiplatelet agent, which is clinically indicated for the treatment of patients with acute coronary syndrome (ACS) or patients with a history of myocardial infarction and at least one risk factor for atherothrombosis. It blocks platelet activation by reversibly binding to platelet P2Y12 ADP (adenosine diphosphate) receptors, thereby reducing the incidence of cardiovascular death, myocardial infarction, and stroke.


Ticagrelor is a non-prodrug that does not require hepatic metabolic activation and is rapid and potent, which can significantly reduce the occurrence of cardiovascular death, myocardial infarction and stroke in patients with ACS, superior to clopidogrel. Since its marketing, ticagrelor has been consistently recommended by authoritative guidelines such as the American Heart Association/American College of Cardiology (AHA/ACC) guidelines, the European Society of Cardiology (ESC) guidelines and Chinese guidelines for percutaneous coronary intervention (PCI), and is the drug of choice for ACS patients on P2Y12 receptor antagonist.



Keyue® (Apixaban Tablets) is an oral anticoagulant indicated for use in adult patients undergoing elective hip or knee replacement surgery and for the prevention of venous thromboembolic events (VTEs). As an active site inhibitor of factor Xa, it is potent, reversible, direct, and highly selective and can effectively inhibit thrombin generation.


In patients undergoing elective hip or knee replacement surgery, apixaban significantly reduced the incidence of the primary composite endpoint of all VTEs/all-cause mortality, and the incidence of the composite endpoint of major VTE endpoint events - proximal deep venous thrombosis (DVT), non-fatal pulmonary embolism (PE) and VTE-related death, compared with enoxaparin. Apixaban has been shown to be safe and well tolerated in Chinese subjects, with few bleeding events reported during the trial. Apixaban is recommended by the American College of Chest Physicians (ACCP) Guidelines on Antithrombotic Therapy for Venous Thromboembolic Events (VTEs) (10th Edition) and the Guidelines for Prevention of Venous Thromboembolism in Major Orthopedic Surgery in China (2016) for the prevention of VTEs after major orthopedic surgery.
In the future, Wanbang Biopharma will continue to fulfill the mission that "We are dedicated to a healthier life", strengthen the R&D of new drugs, and provide more and better products and services for patients.