Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the submission of a market approval application for its in-house developed recombinant human coagulation factor VIIa. The application has been accepted for review by China’s National Medical Products Administration (NMPA). The drug candidate is being developed to treat bleeding episodes in patients with inhibitor positive congenital hemophilia A or B, as well as in specific types of rare hemorrhagic diseases, and for the prevention and treatment of bleeding during surgical or invasive procedures.
Recombinant human coagulation factor VIIa has the ability to bind with tissue factors, activating coagulation factor X to become Xa, which stimulates the conversion of prothrombin to thrombin, leading to blood clot formation. Additionally, it can activate coagulation factor IX to become IXa, further enhancing blood clot formation. At the site of vascular wall injury, coagulation factor VIIa forms a complex with tissue factors/phospholipids, which, when activated, plays a crucial role in hemostasis.
Currently, only Novo Nordisk’s recombinant human coagulation factor VIIa for injection is registered in China, where it has been nationally reimbursed since 2017.- Flcube.com
