HENGRUI PHARMA (01276.HK): Marketing Application for Class 1 Innovative Drug SHR-2004 Injection Accepted by NMPA for VTE Prevention After Knee Replacement Surgery

NewTimeSpace News: On 14 September 2026, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (stock code: 01276.HK) published an overseas regulatory announcement stating that its subsidiary Beijing Shengdi Pharmaceutical Co., Ltd. received a Notice of Acceptance issued by the National Medical Products Administration (NMPA), and that the marketing application for SHR-2004 injection, a Class 1 innovative drug of the Company and a coagulation factor XI (FXI) monoclonal antibody, has been accepted by the NMPA, under acceptance number CXSS2600151, at the marketing application stage, for the proposed indication of preventing venous thromboembolism (VTE) in adult patients undergoing elective knee replacement surgery.

The announcement disclosed that the application is based on a multicentre, randomised, double-blind, active-controlled pivotal Phase III clinical study of SHR-2004 injection in patients undergoing elective total knee arthroplasty (TKA) (study number: SHR-2004-301). The study was co-led by Professor Lei Guanghua of Xiangya Hospital of Central South University and Academician Tang Peifu of the Fourth Medical Centre of the Chinese PLA General Hospital, with 111 sites initiated across the country and 1,165 subjects randomised, making it the first large confirmatory trial of an FXI inhibitor in VTE prevention after TKA in China. The results showed that the VTE incidence at day 12 after TKA in the SHR-2004 90 mg single intravenous dose group was 51% lower than that in the enoxaparin control group (P<0.0001), meeting the pre-set superiority endpoint, with a good safety and tolerability profile, and the results were presented at the 2026 Congress of the International Society on Thrombosis and Haemostasis (ISTH).

SHR-2004 is a novel humanised monoclonal antibody targeting FXI that selectively binds to FXI and activated FXIa, inhibiting the activation of FXI by upstream FXIIa and thrombin, thereby inhibiting the intrinsic coagulation pathway and blocking the coagulation cascade; no drug with the same target is currently marketed. Cumulative R&D investment in the SHR-2004 injection project to date is approximately RMB 309 million (unaudited). The Company cautioned that drug development, from research through clinical trial approval to production, involves a long cycle and multiple stages and is subject to uncertainties.

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