国信证券发布研报称，全球抗凝药市场规模超200亿美元，现有的抗凝药物在预防血栓的同时，会带来 额外的出血风险;抗凝血药物的有效性(抗血栓能力)和安全性(减少出血风险)仍有提升空间。FXI/FXIa有 望成为现有抗凝血药物的升级和补充，具备百亿美金以上的潜在市场空间。建议关注恒瑞医药 (600276.SH，01276)：FXI单抗SHR-2004进入3期临床，在国产分子中领先;并关注拥有FXI小核酸药物管 线的公司。 国信证券主要观点如下： FXI小核酸药物可能具备差异化的竞争优势 FXI小核酸药物仍处在较早期的研发阶段，瑞博生物的SR059、靖因药业的SRSD107正进行2期临床研 究。早期的PK/PD数据显示，FXI siRNA药物对于FXI活性有高效的抑制，并且可能做到Q3M的注射周 期，能为慢病用药带来依从性的优势。 风险提示：临床结果不及预期的风险、临床进度不及预期的风险、海外开发不及预期的风险、商业化不 及预期的风险。 FXI/FXIa抑制剂有望成为安全性更优的抗凝药物 现有抗凝血药物均作用于凝血的共同通路，FXI仅参与内源性凝血通路以及血栓的正反馈放大，抑制 FXI活性有望在抗凝血的同时减少出血的 ...

国信证券主要观点如下： 国信证券发布研报称，全球抗凝药市场规模超200亿美元，现有的抗凝药物在预防血栓的同时，会带来 额外的出血风险;抗凝血药物的有效性(抗血栓能力)和安全性(减少出血风险)仍有提升空间。FXI/FXIa有 望成为现有抗凝血药物的升级和补充，具备百亿美金以上的潜在市场空间。建议关注恒瑞医药 （600276）(600276.SH，01276)：FXI单抗SHR-2004进入3期临床，在国产分子中领先;并关注拥有FXI小 核酸药物管线的公司。 风险提示：临床结果不及预期的风险、临床进度不及预期的风险、海外开发不及预期的风险、商业化不 及预期的风险。 近期，拜耳的asundexian在卒中二级预防的3期临床中取得优效，成为首个达到关键临床主要临床终点的 FXI/FXIa抑制剂。此前，asundexian在房颤患者的卒中预防的3期临床中未达到有效性终点，milvexian在 ACS患者中相比安慰剂同样未达到优效。根据现有临床数据，FXI/FXIa抑制剂相比于DOACs体现出显 著的安全性优势，可能在高出血风险的患者中占据竞争优势。另一方面，在内源性凝血通路的作用占主 导地位的适应症中，FXI/FXIa ...

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]