On the evening of May 31, Hengrui Pharmaceutical issued an announcement saying that it had recently received the Drug Registration Approval issued by the State Food and Drug Administration for approval of the Fondaparinux Sodium Injection. Significantly, this was before (May 18). Day), this species has obtained the FDA approval number.
Fondaparinux selectively inhibits factor Xa mediated by antithrombin III (ATIII), exhibits anticoagulant effects, is suitable for hip fracture prevention surgery (including extended prophylaxis), hip replacement surgery, knee replacement Deep vein thrombosis (DVT) in patients undergoing surgery or abdominal surgery, as well as warfarin therapy for DVT or acute pulmonary embolism.
Fondaparinux sodium injection was developed by US company MYLAN IRELAND LTD. and was first approved for marketing by the FDA on December 7, 2001. In 2009, ARTIXTRA (Android) of Glaxo Group Ltd, UK was approved for listing in China in 2015. Changed to ARTIXTRA (Android) by Aspen Notre Dame de Bondeville, Ireland.
In addition to Hengrui Pharmaceuticals, domestic companies such as China University of Technology (C&D), Tianjin Hongri, Xintai Pharmaceutical, Liaoning Haisike and other companies submitted 6 types of applications. Currently, no domestic enterprises have been approved.
After consulting the IMS database, in 2017, sales of fondaparinux sodium injection in the Chinese market was approximately US$ 2.94 million, US market sales were approximately US$ 69.53 million, and global market sales were approximately US$ 190 million.
Up to now, Hengrui has spent R&D expenses of approximately 79 million yuan on this project.
