Hengrui Medicine: Marketing authorization application for SHR-2004 injection accepted

Hengrui Medicine announced that its subsidiary, Beijing Shengdi Pharmaceutical, received a Notice of Acceptance issued by the National Medical Products Administration, and the marketing authorization application for the company's Class 1 innovative drug, coagulation factor XI monoclonal antibody SHR-2004 injection, has been accepted. The proposed indication for this drug is for adult patients undergoing elective knee replacement surgery to prevent venous thrombosis. Its pivotal Phase III clinical study showed that the VTE incidence rate on day 12 after surgery in the 90 mg single intravenous dose group was 51% lower than that in the enoxaparin control group, achieving the superiority endpoint, with good safety and tolerability. As of now, cumulative R&D investment in this project is approximately RMB 309 million, and no drug targeting the same target is currently on the market.