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FXI/FXIa抑制剂研发
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国信证券:FXI抑制剂有望成为下一代抗凝药物 建议关注恒瑞医药(600276.SH)
智通财经网· 2025-12-15 02:59
Group 1 - The global anticoagulant market exceeds $20 billion, with existing anticoagulants posing additional bleeding risks while preventing thrombosis. There is room for improvement in both efficacy and safety of these drugs [1] - FXI/FXIa inhibitors are expected to become safer alternatives to current anticoagulants, as they specifically target the intrinsic coagulation pathway, potentially reducing bleeding risks while maintaining anticoagulant efficacy [1] - No FXI/FXIa inhibitors have been approved yet, but several candidates, including Novartis' abelacimab, Bayer's asundexian, and BMS/Johnson & Johnson's milvexian, are in registration clinical trials [1] Group 2 - Bayer's asundexian has shown superior efficacy in phase 3 clinical trials for secondary stroke prevention, marking it as the first FXI/FXIa inhibitor to meet key clinical endpoints [1] - FXI/FXIa inhibitors demonstrate significant safety advantages over DOACs, particularly in patients at high risk of bleeding, and are expected to challenge standard treatments in various indications [1] - FXI small nucleic acid drugs, still in early development, show promising early pharmacokinetic and pharmacodynamic data, with potential for improved patient compliance due to less frequent dosing [2]
国信证券:FXI抑制剂有望成为下一代抗凝药物 建议关注恒瑞医药
Zhi Tong Cai Jing· 2025-12-15 02:59
Group 1 - The global anticoagulant market exceeds $20 billion, with existing anticoagulants posing additional bleeding risks while preventing thrombosis. There is room for improvement in both efficacy and safety of these drugs [1] - FXI/FXIa inhibitors are expected to become safer alternatives to current anticoagulants, as they specifically target the intrinsic coagulation pathway, potentially reducing bleeding risks while maintaining anticoagulation efficacy [1] - No FXI/FXIa inhibitors have been approved yet, but various drug forms, including monoclonal antibodies and small molecules, are in clinical stages, with several candidates like Novartis' abelacimab and Bayer's asundexian undergoing registration trials [1] Group 2 - Bayer's asundexian has achieved superior efficacy in phase 3 clinical trials for secondary stroke prevention, marking it as the first FXI/FXIa inhibitor to meet key clinical endpoints [2] - FXI/FXIa inhibitors demonstrate significant safety advantages over DOACs, particularly in patients with high bleeding risks, suggesting a competitive edge in these populations [2] - FXI small nucleic acid drugs, still in early development, show promising early pharmacokinetic and pharmacodynamic data, indicating effective FXI activity suppression and potential for improved patient compliance with a quarterly injection schedule [3]
寻找未被满足的临床需求(4):FXI抑制剂有望成为下一代抗凝药物
Guoxin Securities· 2025-12-14 15:01
Investment Rating - The report maintains an "Outperform" rating for the industry [1] Core Insights - The global anticoagulant market exceeds $20 billion, primarily driven by stroke prevention in atrial fibrillation patients, with other indications including VTE prevention after knee/hip replacement and prevention of ischemic complications in myocardial infarction [2][5] - FXI/FXIa inhibitors are expected to become safer anticoagulants, as they target the intrinsic pathway of coagulation, potentially reducing bleeding risks while maintaining efficacy [2][21] - Several FXI/FXIa inhibitors are in clinical stages, with promising safety profiles demonstrated in various indications, including Bayer's asundexian achieving key clinical endpoints in secondary stroke prevention [2][26] - FXI small nucleic acid drugs may offer differentiated competitive advantages, with early-stage clinical data showing effective FXI activity suppression and potential for improved patient compliance [2][26] Summary by Sections Anticoagulant Drugs: Applications and Market Size - Anticoagulants are used in various medical scenarios, with a global market size exceeding $20 billion, driven by stroke prevention in atrial fibrillation patients [5][7] - Current anticoagulants include DOACs and low molecular weight heparins, with existing drugs presenting bleeding risks alongside their efficacy [5][21] FXI Inhibitors as Next-Generation Anticoagulants - FXI inhibitors are positioned to challenge standard treatments, with clinical trials indicating superior safety profiles compared to existing DOACs [2][26] - Notably, Bayer's asundexian has shown efficacy in secondary stroke prevention, marking a significant advancement in the field [2][69] Domestic FXI Small Nucleic Acid Drug Development Progress - Domestic companies are advancing in FXI small nucleic acid drug development, with promising early clinical results indicating effective FXI suppression and potential for improved dosing schedules [2][26] Investment Recommendations - FXI/FXIa inhibitors are projected to represent an upgrade and complement to existing anticoagulants, with a potential market space exceeding $10 billion [2][26] - The report suggests focusing on companies like HengRui Medicine, which is leading in domestic FXI monoclonal antibody development [2][26]