Demographic aging and rising prevalence of cardiovascular diseases are driving continuous expansion in the antithrombotic drug market. Anticoagulants, as a core category, are experiencing steady growth in demand, with particularly significant growth rates in the Chinese market. This establishes a broad foundation for the development and commercialization of novel anticoagulants. With unique advantages of "precise anticoagulation and low bleeding risk," Factor XI (FXI) has emerged as an ideal target for next-generation anticoagulants. Currently, multiple FXI/FXIa inhibitors are in pivotal clinical stages globally, spanning small molecules, monoclonal antibodies, and siRNA technologies, and covering indications such as atrial fibrillation, stroke prevention, and venous thromboembolism.
Key points from the analysis are as follows:
The antithrombotic drug market is expanding, with evolving dynamics. Thrombotic diseases have become a leading cause of death worldwide. Aging populations and increasing cardiovascular disease rates are fueling market growth, with the global market reaching $52.9 billion in 2023 and projected to exceed $110 billion by 2033. Anticoagulants, as a central segment, show steady demand growth, especially in China, providing a strong basis for new drug development and commercialization.
The window for anticoagulant advancement has arrived, with next-generation drugs on the horizon. Traditional anticoagulants face challenges in balancing efficacy and bleeding risks. Novel oral anticoagulants (NOACs) have improved upon the limitations of warfarin. Drugs such as Bayer/J&J's Xarelto (rivaroxaban) and BMS/Pfizer's Eliquis (apixaban) have achieved blockbuster status, with sales exceeding billions, yet bleeding complications remain a concern. With core patents for "xaban" drugs nearing expiration, generic competition is set to reshape the market, making the development of next-generation anticoagulants an industry imperative.
FXI initiates a new anticoagulation era, with multiple technological pathways competing in a promising field. Research indicates that coagulation factor XI (FXI) is a key driver of pathological thrombosis but is largely non-essential for normal hemostasis. For instance, individuals with hereditary FXI deficiency show significantly lower thrombosis rates without a marked increase in spontaneous bleeding risk. Leveraging its precision and safety profile, FXI is an ideal target. Several FXI/FXIa inhibitors are now in registration-stage clinical trials worldwide, utilizing small molecules, monoclonal antibodies, and siRNA approaches across indications including atrial fibrillation, stroke prevention, and venous thromboembolism.
1) Among small molecule FXIa inhibitors, Bayer's Asundexian showed mixed Phase III results—underperforming standard therapy in stroke prevention for atrial fibrillation but succeeding in preventing recurrent non-cardioembolic ischemic stroke. BMS/J&J's Milvexian failed a Phase III trial for acute coronary syndrome but continues to be evaluated for non-cardioembolic stroke and atrial fibrillation.
2) In monoclonal antibodies targeting FXI, Novartis's Abelacimab has received two FDA Fast Track designations for stroke prevention in atrial fibrillation and cancer-associated thrombosis, and is advancing in Phase III trials. Regeneron is pursuing a dual pipeline with REGN7580, which directly blocks FXI's catalytic domain, and REGN9933, which binds the A2 domain, both in Phase III studies. HENGRUI PHARMA's SHR-2004 has also initiated China's first Phase III clinical trial in this category.
3) siRNA-based therapies are exploring longer-acting and safer treatment options. RIBOLIFE-B and Jingyin Pharmaceutical are leading globally, having entered Phase II trials for different indications.
Recommended stock: HENGRUI PHARMA (01276). Related companies: RIBOLIFE-B (06938), Jingyin Pharmaceutical.
Risks include potential delays in R&D, slower-than-expected commercialization and clinical adoption, and intensifying market competition.
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