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 ...

Group 1 - Bayer's oral anticoagulant Asundexian achieved a 26% reduction in the risk of recurrent non-cardioembolic ischemic stroke in the OCEANIC-STROKE Phase 3 trial, without increasing the risk of major bleeding. The company plans to submit a New Drug Application to the FDA by the end of 2026, positioning Asundexian as a potential blockbuster product [1] - The U.S. EPA approved the federal registration of the low-volatility herbicide Stryax, which Bayer plans to launch in the 2026 planting season to address herbicide-resistant weed issues, subject to strict application restrictions [1] - Bayer's crop science division is responding to China's 2026 Central No. 1 Document by promoting high-yield corn varieties through local R&D, contributing to the development of new agricultural productivity [1] Group 2 - Bayer aims to save €2 billion annually starting in 2026 through its DSO operational model and plans to divest non-core assets, such as the moxifloxacin business, to focus on its innovative drug pipeline [1] - Bayer's original drugs, including acarbose, won bids in the national drug procurement process, covering treatment areas such as diabetes [1] - Bayer's stock price showed slight fluctuations, closing at $13.50 on February 12, with a year-to-date increase of 24.77%, indicating a generally positive long-term sentiment [2] Group 3 - Key drivers for Bayer in 2026 include the approval progress of innovative drugs like Asundexian, cost-saving initiatives, and improved profitability in crop science, although challenges such as patent cliffs and litigation risks may hinder growth [3] - Institutions like WuXi AppTec highlighted the positive Phase 3 data for Asundexian, suggesting it could transform the secondary prevention market for strokes [3]

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

Company Developments - Bayer's new oral anticoagulant Asundexian has completed Phase 3 clinical trials and is expected to receive FDA approval by the end of 2026, viewed as a key product with blockbuster potential [2] - The company plans to achieve five significant milestones in the first half of 2026, focusing on expanding indications for existing products and releasing new data to strengthen its position in innovative drug development [2] Strategic Initiatives - Bayer's Dynamic Shared Responsibility (DSO) operational model, initiated in 2023, aims to save €2 billion annually starting in 2026 through organizational streamlining and improved decision-making efficiency [3] - The company will continue to focus on four strategic areas: innovation, addressing litigation issues in the U.S., improving cash flow, and enhancing profitability in its crop science business, with the pharmaceutical sector (especially in oncology, cardiovascular, neuroscience, and rare diseases) seen as a core growth engine [3] Company Status - Bayer has divested non-core assets, such as the global business of the antibiotic moxifloxacin, to concentrate resources on its more promising innovative drug pipeline [4] Future Outlook - Bayer's core products, rivaroxaban (Xarelto) and aflibercept (Eylea), will continue to face sales pressure from generic competition in 2026, although the company anticipates that this pressure will gradually ease after 2026 [5] - Ongoing litigation related to glyphosate from the acquisition of Monsanto remains a significant uncertainty that requires continuous monitoring [6]

Core Insights - The OCEANIC-STROKE Phase III trial results are being presented at ISC 2026 in New Orleans, indicating significant advancements in secondary stroke prevention [1][2] - Bayer's team includes key figures in clinical development and neurology, highlighting the importance of collaboration in addressing unmet medical needs [2] Group 1: Unmet Medical Needs - There remains a significant unmet medical need in the secondary stroke prevention setting, which is a focus of Bayer's ongoing research efforts [2] Group 2: Trial Data and Implications - Ashkan Shoamanesh, a principal investigator of the OCEANIC-STROKE trial, will present the trial data, which is expected to be favorable [2] - The data from the trial may provide insights into potential treatment options for secondary stroke prevention [2] Group 3: Health Economic Challenges - Jan Voss will discuss health economic challenges in the secondary stroke setting and how asundexian could potentially address these issues in the future [2]

Core Insights - Bayer presented positive results from the late-stage OCEANIC-STROKE study for its investigational oral factor XIa inhibitor asundexian, showing significant efficacy in secondary stroke prevention [1][2][9] Group 1: Study Results - The OCEANIC-STROKE study involved 12,327 patients and demonstrated that asundexian (50 mg once daily) significantly reduced the risk of recurrent ischemic stroke by 26% compared to placebo, without increasing the risk of major bleeding [3][4][9] - The primary endpoint was the time to ischemic stroke, while the primary safety endpoint focused on major bleeding events [3] Group 2: Regulatory and Market Potential - Asundexian has received Fast Track designation from the FDA for stroke prevention, and Bayer plans to submit the study data for marketing approval, indicating strong regulatory momentum [5][9] - The drug is viewed as a potential blockbuster in a market with a high risk of recurrent strokes, which could significantly enhance Bayer's cardiovascular portfolio [5] Group 3: Cardiovascular Portfolio Development - Bayer's cardiovascular portfolio includes Kerendia, which received FDA approval for heart failure treatment in 2025, and is the only non-steroidal mineralocorticoid receptor antagonist approved for chronic kidney disease associated with type 2 diabetes [6][7] - The company is also advancing next-generation assets, including AB-1002 for congestive heart failure and aficamten for hypertrophic cardiomyopathy, further strengthening its precision cardiology portfolio [10][11] Group 4: Financial Performance - Bayer's shares have increased by 151.9% over the past year, significantly outperforming the industry average of 14%, driven by new drug approvals and positive pipeline developments [12] - The performance of new drugs like Nubeqa and Kerendia has offset declines in Xarelto sales, indicating a robust pharmaceutical division [13]

Bayer (OTCPK:BAYR.Y) Update / briefing February 06, 2026 09:00 AM ET Company ParticipantsAlek Ebbeling - Associate Director of Pharmaceuticals Equity ResearchAlexander Seidler - Head of Investor RelationsAshkan Shoamanesh - Professor of Neurology, and Director of the Stroke ProgramChristoph Koenen - Global Head of Clinical Development and OperationsJan Foss - Global Head of AsundexianRajesh Kumar - Head of European Life Sciences and Healthcare ResearchConference Call ParticipantsCharles Pitman-King - Direct ...

Core Insights - Bayer presented results from the pivotal Phase III OCEANIC-STROKE study, demonstrating the efficacy of its investigational oral Factor XIa inhibitor asundexian [1] Group 1: Study Results - Asundexian (50mg) significantly reduced the incidence of ischemic stroke by 26% compared to placebo, with a confidence interval of 95% (csHR 0.74; 95% CI 0.65–0.84; p) [1]

Core Insights - Bayer AG's shares rose by 6.6% following Orion's projection that long-term annual net sales from Nubeqa could exceed €1 billion, based on collaborative scenario planning [1][7] Group 1: Product Performance and Strategic Priorities - Nubeqa, developed jointly by Bayer and Orion, is approved for various prostate cancer indications in the U.S. [2] - Bayer outlined its strategic priorities for the Pharmaceuticals Division at the J.P. Morgan Healthcare Conference, emphasizing the strong performance of Nubeqa and Kerendia, which are offsetting declining sales of Xarelto [3][4] - Bayer's stock surged 126% over the past year, significantly outperforming the industry growth of 22.7% [4] Group 2: Future Growth Drivers - Bayer is focusing on new drug launches such as Beyonttra, Lynkuet, and asundexian to drive future growth [5][7] - Kerendia received FDA approval for expanded use in heart failure patients, becoming the only non-steroidal mineralocorticoid receptor antagonist approved for chronic kidney disease associated with type 2 diabetes [8] - Asundexian, an investigational oral Factor XIa inhibitor, has shown promising results in late-stage studies and is viewed as a potential blockbuster opportunity [10] Group 3: Oncology and Women's Health Developments - Nubeqa continues to show strong global uptake, with additional phase III readouts expected to extend its use [14] - The FDA approved elinzanetant for menopause-related symptoms, marking a significant boost for Bayer's women's health portfolio [17] - Bayer's pipeline includes advancements in cell therapy and gene therapy, with ongoing developments in treatments for Parkinson's disease and late-onset Pompe disease [18][19] Group 4: Overall Business Outlook - Bayer's pharmaceutical business is entering a new growth phase, supported by key revenue drivers, multiple late-stage catalysts, and a robust pipeline [20]