Hengrui Pharmaceuticals' subsidiary, Beijing Shengdi Pharmaceutical Co., Ltd., has recently received the official "Acceptance Notification" from the National Medical Products Administration (NMPA) for its Class 1 innovative drug, SHR-2004, a monoclonal antibody targeting coagulation Factor XI (FXI). The marketing authorization application for this injection has been accepted for the proposed indication of preventing venous thromboembolism (VTE) in adult patients undergoing elective total knee replacement surgery.
About the SHR-2004-301 Clinical Study
This regulatory submission is supported by a pivotal Phase III clinical trial (Study Number: SHR-2004-301), a multicenter, randomized, double-blind, active-controlled study evaluating the efficacy and safety of SHR-2004 for VTE prophylaxis in patients scheduled for total knee arthroplasty (TKA). The study was co-led by Professor Lei Guanghua from Xiangya Hospital of Central South University and Academician Tang Peifu from the Fourth Medical Center of the Chinese PLA General Hospital. It involved 111 centers nationwide and enrolled 1,165 randomized subjects, representing the first large-scale confirmatory trial for FXI inhibitors in VTE prevention following TKA in China. Results demonstrated that a single intravenous 90 mg dose of SHR-2004 significantly reduced VTE incidence on day 12 post-TKA by 51% compared to the enoxaparin control group (P<0.0001), meeting the pre-specified superiority endpoint with favorable safety and tolerability. These findings were presented at the 2026 International Society on Thrombosis and Haemostasis (ISTH) Congress.
Understanding Venous Thromboembolism (VTE)
VTE represents the most prevalent severe complication after total knee replacement, with pulmonary embolism and occult deep vein thrombosis posing significant threats to patient recovery. Current standard therapies—such as low molecular weight heparins (e.g., enoxaparin) and direct oral anticoagulants (DOACs)—reduce postoperative VTE rates but have inherent limitations. Low molecular weight heparins require daily subcutaneous injections, which impair patient compliance and offer limited preventive efficacy, while DOACs are inconvenient for early postoperative administration due to their oral route and carry elevated bleeding risks. Consequently, there remains an urgent clinical demand for novel anticoagulants that deliver robust efficacy, superior safety profiles, and enhanced patient adherence.
About SHR-2004
SHR-2004 is a humanized monoclonal antibody targeting the FXI pathway, designed to specifically bind to both Factor XI and its activated form Factor XIa, thereby blocking the intrinsic thrombus amplification loop while preserving fundamental hemostatic function. This mechanism achieves a precise balance of "antithrombotic activity without compromising hemostasis," potentially offering a novel therapeutic option for VTE prevention in TKA patients. Additionally, a Phase II trial of SHR-2004 for VTE prophylaxis in ovarian cancer surgery patients has been completed.
References
1. Efficacy and safety of SHR-2004 for venous thromboembolism prevention after elective total knee arthroplasty: results from a randomized, double-blind, active-controlled phase 3 study, ISTH 2026, Abstract Presentation Number: LB01.2.
2. Chinese Journal of Orthopaedics, 2016(2): 65-71.
3. BMJ. 2012 Jun 14; 344: e3675.
4. Drug Ther Bull. 2017 Nov; 55(11): 129-132.
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2. Hengrui Pharmaceuticals does not endorse any unapproved drugs or indications.