抗凝药物升级窗口已至，下一代药物箭在弦上 国泰海通发布研报称，人口老龄化与心血管疾病患病率攀升推动抗血栓药物市场持续扩容，其中抗凝药 物作为核心品类，市场需求稳步增长，中国市场增速尤为显著，为新型抗凝药物研发与商业化奠定了广 阔的市场基础。凭借"精准抗凝、低出血风险"的独特优势，FXI成为下一代抗凝药的理想靶点，目前全 球有多款FXI/FXIa抑制剂进入注册性临床阶段，涵盖小分子、大分子单抗、siRNA等多种技术路线，覆 盖房颤、卒中预防、静脉血栓栓塞等多个适应症。 国泰海通主要观点如下： 抗血栓药物市场需求扩容，格局待新 血栓性疾病成为全球主要死亡原因之一，人口老龄化与心血管疾病患病率攀升推动抗血栓药物市场持续 扩容，2023年全球市场规模已达529亿美元，预计2033年将突破1100亿美元。其中抗凝药物作为核心品 类，市场需求稳步增长，中国市场增速尤为显著，为新型抗凝药物研发与商业化奠定了广阔的市场基 础。 2)大分子FXI单抗中，诺华的Abelacimab已获得FDA两项快速通道资格，分别针对房颤卒中预防及肿瘤 相关血栓，目前正在推进III期临床；再生元双管线布局FXI单抗，直接阻断FXI的催化结构域的 ...

从靶点到管线，FXI 引领抗凝产业新变革 [Table_Industry] 医药 FXI/FXIa 抑制剂行业研究报告 | [Table_Invest] | | | --- | --- | | 评级： | 增持 | | | | | [姓名table_Authors] | 电话 | 邮箱 | 登记编号 | | --- | --- | --- | --- | | 彭娉(分析师) | 021-23185619 | pengping@gtht.com | S0880525040080 | | 余文心(分析师) | 021-38676666 | yuwenxin@gtht.com | S0880525040111 | 本报告导读： 靶向 FXI 的药物可在不显著增加出血风险的前提下防治血栓，有望为患者提供更安 全的抗凝选择。当前该领域的研发活跃，2026 年起预计有多个药物进入关键数据读 出的阶段，静待抗凝领域新一代"大药"的诞生。 投资要点： [Table_Report] 相关报告 医药《医疗设备招采规模高基数影响部分回落， 关注手术机器人市场机遇》2026.02.09 医药《高景气延续，持续推荐创新药械产业链》 2 ...

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]

Investment Rating - The report indicates a positive investment outlook for the oral FXIa inhibitor asundexian, particularly following its successful Phase III trial results for preventing recurrent strokes [21][25]. Core Insights - The oral FXIa inhibitor asundexian has shown significant efficacy in reducing the risk of ischemic stroke in patients with non-cardioembolic ischemic stroke or high-risk transient ischemic attack, achieving its primary efficacy and safety endpoints in the OCEANIC-STROKE study [21][25]. - The report highlights the potential of FXI inhibitors to provide safer anticoagulation options with lower bleeding risks compared to traditional anticoagulants [9][10]. - The report discusses the diverse potential indications for FXI/XIa inhibitors, including prevention of venous thromboembolism (VTE) in orthopedic surgeries, stroke prevention in atrial fibrillation patients, and treatment of cancer-associated VTE [13][10]. Summary by Sections Section 1: Focus on Innovative Drugs - The report reviews the recent advancements in innovative drugs, particularly in the anticoagulant space, emphasizing the role of FXI inhibitors [4][5]. Section 2: Mechanism of Action - FXIa plays a crucial role in pathological thrombus formation while having a limited role in hemostasis, making it an ideal target for developing safer anticoagulants [9][10]. Section 3: Clinical Development Progress - Asundexian has successfully completed Phase III trials, while other FXIa inhibitors like milvexian have faced challenges, including trial terminations due to efficacy concerns [30][33]. - The report details the ongoing clinical trials for various FXI inhibitors, including those by companies like Bayer, BMS, and Regeneron, highlighting their respective stages of development and potential applications [20][39][45]. Section 4: Market Potential - The report underscores the significant market potential for FXI inhibitors, given the high incidence of stroke and VTE, with approximately 12 million people affected by stroke annually worldwide [25][21].

Core Insights - Regeneron Pharmaceuticals has reported positive Phase 2 trial results for two investigational factor XI antibodies, REGN7508 and REGN9933, aimed at preventing blood clotting in patients undergoing total knee replacement surgery [2][3][5] - The antibodies are designed to have distinct profiles, with REGN7508 providing stronger anticoagulation and REGN9933 offering a lower risk of bleeding, allowing for tailored anticoagulant therapy based on patient risk profiles [2][3][12] Trial Results - The trials included two open-label, active-controlled Phase 2 studies: ROXI-VTE-I and ROXI-VTE-II, evaluating the efficacy of a single intravenous dose of REGN7508 and REGN9933 for preventing venous thromboembolism (VTE) after knee arthroplasty [4][11] - REGN7508 reduced VTE rates to 7.1%, superior to apixaban's rate of 12.4%, while REGN9933 decreased VTE rates to 17.2%, superior to enoxaparin's rate of 20.6% [5][7] Safety Profile - Both antibodies demonstrated robust anti-clotting effects with no clinically relevant bleeding reported in any treatment arm, indicating a favorable safety profile [5][8][13] - The only treatment-related adverse event was minimal bleeding in the enoxaparin arm, with overall adverse event rates being similar across treatment groups [7][8] Future Development - Regeneron is advancing its factor XI program with ongoing Phase 3 trials for REGN7508, including ROXI-APEX and ROXI-ASPEN, and plans to initiate additional trials for various indications in 2026 [14][12] - The company aims to explore the use of these antibodies in other clinical settings, including atrial fibrillation and cancer-associated thrombosis [14][12]