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 ...

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]