At the 2026 International Society on Thrombosis and Haemostasis (ISTH) Congress held in Paris from July 11th to 15th, significant positive results from the confirmatory Phase III study of Hengrui Pharma's self-developed coagulation factor XI (FXI) monoclonal antibody, SHR-2004, were presented. The drug is intended for the prevention of venous thromboembolism (VTE) following elective total knee arthroplasty (TKA).
Key Phase III Trial Findings
The SHR-2004-301 study demonstrated that a single 90mg intravenous dose of SHR-2004 significantly reduced the composite endpoint of VTE events by 51% compared to the control group receiving enoxaparin. The VTE incidence rate by day 12 was 10.6% in the SHR-2004 90mg group versus 21.9% in the enoxaparin group, meeting the pre-specified superiority endpoint.
Safety Profile and Administration
Regarding safety, the composite endpoint of bleeding events was comparable across groups, with rates of 1.9% for the SHR-2004 90mg group, 2.1% for the 120mg subcutaneous group, and 1.9% for the enoxaparin control. A key advantage of SHR-2004 is its single-dose regimen, administered once within 4-8 hours post-surgery, which simplifies perioperative management and is expected to improve patient compliance compared to daily injection therapies.
Strategic Significance and Next Steps
This marks the first FXI monoclonal antibody globally to successfully complete a Phase III confirmatory study for VTE prevention after major orthopedic surgery with positive superiority results. Hengrui Pharma plans to submit a new drug application in China for this indication within the current year. SHR-2004, with its mechanism of targeting the FXI pathway to inhibit thrombosis while preserving hemostasis, represents a potential new solution for perioperative anticoagulation challenges in orthopedics.
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