拜耳的Asundexian在具有里程碑意义的III期OCEANIC-STROKE研究中达到了主要疗效和安全性终点，用于二级卒中预防-动脉网

Bayer’s Asundexian Met Primary Efficacy and Safety Endpoints in Landmark Phase III OCEANIC-STROKE Study in Secondary Stroke Prevention

拜耳等信源发布 2025-11-23 00:12

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November

十一月

2025

17:06 PM

17:06 下午

Europe/Amsterdam

欧洲/阿姆斯特丹

Bayer’s Asundexian Met Primary Efficacy and Safety Endpoints in Landmark Phase III OCEANIC-STROKE Study in Secondary Stroke Prevention

拜耳的Asundexian在具有里程碑意义的III期OCEANIC-STROKE研究中达到了主要疗效和安全性终点，用于二级卒中预防。

Not intended for UK Media

不适用于英国媒体

Summary

摘要

OCEANIC-STROKE demonstrates superiority of asundexian with antiplatelet therapy, showing significant reduction in ischemic stroke risk, without increasing ISTH major bleeding rate, compared to placebo with antiplatelet therapy / OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor / Bayer will globally engage with health authorities in preparation for the submission of marketing authorization applications and looks forward to presenting the results at an upcoming scientific congress.

OCEANIC-STROKE 证实了 asundexian 联合抗血小板治疗的优越性，与单独使用安慰剂和抗血小板治疗相比，显著降低了缺血性中风风险，且未增加 ISTH 主要出血率 / OCEANIC-STROKE 是首个成功完成的 Factor XIa 抑制剂 III 期研究 / 拜耳将与全球卫生机构合作，为提交上市许可申请做准备，并期待在即将召开的科学大会上展示研究结果。

Berlin, November 23, 2025

柏林，2025年11月23日

– Bayer today announced positive topline results from the global Phase III study OCEANIC-STROKE, with its investigational, once daily, oral FXIa inhibitor asundexian. The study met its primary efficacy and safety endpoints. Asundexian 50 mg once daily significantly reduced the risk of ischemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke or high-risk ischemic attack.

– 拜耳今天宣布了全球III期OCEANIC-STROKE研究的积极顶线结果，该研究涉及其在研的每日一次口服FXIa抑制剂asundexian。该研究达到了主要疗效和安全性终点。在非心源性缺血性卒中或高危缺血性发作后的患者中，与安慰剂相比，每日一次50 mg的asundexian在与抗血小板治疗联合使用时显著降低了缺血性卒中的风险。

There was no increase in the risk of ISTH major bleeding in patients treated with asundexian compared to placebo, both in combination with antiplatelet therapy. Detailed results of OCEANIC-STROKE will be presented at an upcoming scientific congress..

与安慰剂相比，接受asundexian治疗的患者发生ISTH主要出血的风险没有增加，且两组均联合抗血小板治疗。OCEANIC-STROKE的详细结果将在即将召开的科学大会上公布。

Each year, approximately 12 million people worldwide will experience a stroke. Of these, 20-30% will be a recurrent stroke.

每年，全球大约有 1200 万人会经历中风。其中，20%-30% 的中风为复发性中风。

1,2

Despite available secondary stroke prevention options, the risk of secondary stroke remains high. One in five stroke survivors will have another stroke within five years.

尽管有可用的二级卒中预防措施，但二级卒中的风险仍然很高。五分之一的卒中幸存者将在五年内再次发生卒中。

Stroke is the second leading cause of death globally, and recurrent ischemic strokes tend to be more disabling and carry a higher mortality risk than the first stroke.

中风是全球第二大死亡原因，复发性缺血性中风往往比第一次中风更具致残性，并且有更高的死亡风险。

2,4,5

2，4，5

“As clinicians, we see every day how devastating a recurrent stroke can be for patients and their families

“作为临床医生，我们每天都能看到复发性中风对患者及其家庭造成的毁灭性影响。

,” said Mike Sharma, MD, principal investigator of the Population Health Research Institute (PHRI) OCEANIC-STROKE study, Senior Scientist at PHRI (a joint institute of McMaster University and Hamilton Health Sciences), Director of the Stroke Program at Hamilton Health Sciences, and Michael G. DeGroote Chair in Stroke Prevention at McMaster University.

麦克·夏尔马博士说道，他是人口健康研究所（PHRI）OCEANIC-STROKE研究的首席研究员，PHRI（麦克马斯特大学和汉密尔顿健康科学联合研究所）的资深科学家，汉密尔顿健康科学中风项目的主任，以及麦克马斯特大学Michael G. DeGroote中风预防主席。

“Even with currently available therapies, the risk of another stroke remains high, and each recurrence can have profound consequences. The topline results from OCEANIC-STROKE indicate that asundexian may become a new treatment option to reduce this risk – representing a potential major step forward in secondary stroke prevention.”.

“即使使用目前可用的疗法，再次中风的风险仍然很高，每次复发都可能带来严重后果。OCEANIC-STROKE 的主要结果表明，asundexian 可能成为降低这种风险的新治疗选择——代表了中风二级预防潜在的重大进步。”

“We are excited by these positive topline findings which highlight the potential of Factor XIa inhibition as a new way to help protect patients from a recurrent stroke,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “This marks an important milestone in Bayer’s longstanding commitment to advancing innovation in thrombosis prevention.

“我们对这些积极的初步结果感到兴奋，这些结果突显了抑制XI因子作为帮助保护患者免受中风复发的新方法的潜力，”拜耳制药部门研发主管克里斯蒂安·罗梅尔博士表示。“这标志着拜耳在推进血栓预防创新方面长期承诺的重要里程碑。”

We extend our sincere gratitude to the investigators, patients, and colleagues whose dedication made this milestone possible.”.

我们谨向使这一里程碑成为可能的调查人员、患者和同事们表示衷心感谢。"

Asundexian has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. Asundexian is an investigational compound and has not been approved by any health authority for use in any country for any indication..

Asundexian 已被美国食品药品监督管理局 (FDA) 授予快速通道资格，作为非心源性缺血性卒中患者卒中预防的潜在治疗药物。Asundexian 是一种研究性化合物，尚未获得任何卫生部门批准在任何国家用于任何适应症。

About OCEANIC-STROKE

关于海洋笔触

The

OCEANIC-STROKE

海洋笔触

study investigated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once daily compared to placebo, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) in combination with antiplatelet therapy.

研究调查了口服因子XIa抑制剂阿松地昔50毫克每日一次与安慰剂相比，在非心源性缺血性卒中或高危短暂性脑缺血发作（TIA）患者中，联合抗血小板治疗预防缺血性卒中的疗效和安全性。

It is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that has enrolled over 12,300 patients. The main study results will be presented at an upcoming scientific congress..

这是一项多中心、国际、随机、安慰剂对照、双盲、平行组和事件驱动的研究，已招募了超过12,300名患者。主要研究结果将在即将召开的科学大会上公布。

About FXIa inhibitors and Asundexian

关于FXIa抑制剂和阿松地昔

Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. FXIa has a minor role in the formation of a hemostatic plug that seals the leak at the site of vessel injury. However, FXIa is thought to contribute to the formation of pathological thrombus growth and vessel blockage.

因子XIa（FXIa）是血液凝固途径中的一种蛋白质，在止血和血栓形成中具有不同作用。FXIa在形成封闭血管损伤部位的止血栓中起次要作用。然而，FXIa被认为有助于病理性血栓的生长和血管阻塞。

Asundexian, a direct inhibitor of FXIa, is theorized to reduce thrombus formation that can lead to vessel stenosis or blockage, without a significant increase in major bleeding. Asundexian is currently being evaluated as a potential treatment option in thrombosis prevention. Asundexian is a once-daily, oral investigational agent and has not been approved by any health authority for use in any country, for any indication. .

Asundexian 是一种直接抑制 FXIa 的药物，理论上可减少导致血管狭窄或阻塞的血栓形成，而不会显著增加大出血风险。Asundexian 目前正在评估作为预防血栓形成的潜在治疗选择。Asundexian 是一种每日一次的口服研究性药物，尚未获得任何卫生部门批准在任何国家用于任何适应症。

About Bayer’s Commitment in Cardiovascular Diseases

关于拜耳在心血管疾病方面的承诺

Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) diseases of high unmet medical need. We have set a clear focus on developing innovative therapies to treat cardiovascular diseases (e.g., stroke, heart failure, cardiomyopathies, and chronic kidney disease) and it is our ambition to take a leading role in the care of patients with these diseases.

拜耳在心脏病学领域处于领先地位，正在推进一系列针对高未满足医疗需求的心血管（CV）疾病的创新治疗组合。我们明确专注于开发创新疗法以治疗心血管疾病（例如，中风、心力衰竭、心肌病和慢性肾病），我们的目标是在这些疾病的患者护理中发挥主导作用。

Our strategy is to unlock the strong potential of the future CV market by transforming Bayer’s portfolio into precision cardiology, addressing the high CV disease burden, and driving the long-term growth. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development..

我们的战略是通过将拜耳的产品组合转型为精准心脏病学，解决心血管疾病高负担问题，并推动长期增长，从而释放未来心血管市场巨大的潜力。拜耳的产品组合已经包括多个处于临床前和临床开发不同阶段的创新产品和化合物。

About Bayer

关于拜耳

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家在医疗保健和营养等生命科学领域具有核心竞争力的全球性企业。秉承“人人健康，无人饥饿”的使命，公司通过支持应对不断增长和老龄化的全球人口所带来的重大挑战，设计其产品和服务以帮助人类和地球繁荣发展。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros.

拜耳致力于通过其业务推动可持续发展并产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表信任、可靠性和质量。在2024财年，集团拥有约93,000名员工，销售额达466亿欧元。

R&D expenses amounted to 6.2 billion euros. For more information, go to .

研发费用共计62亿欧元。欲了解更多信息，请访问。

www.bayer.com

。

Find more information at

更多信息请访问

https://pharma.bayer.com

在Facebook上关注我们：

http://www.facebook.com/bayer

在LinkedIn上关注我们：

Bayer | Pharmaceuticals

拜耳 | 制药

Forward-Looking Statements

前瞻性声明

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

本发布可能包含基于拜耳管理层当前假设和预测的前瞻性声明。各种已知和未知的风险、不确定性和其他因素可能导致公司的实际未来结果、财务状况、发展或业绩与这里提供的估计存在重大差异。

These factors include those discussed in Bayer’s public reports which are available on the Bayer website at .

这些因素包括拜耳公开报告中讨论的因素，该报告可在拜耳网站上查阅。

www.bayer.com

. The company assumes no liability whatsoever to update these forward-looking statements or to conform

公司不承担更新这些前瞻性声明或使其符合的任何责任 whatsoever

them to future events or developments.

将它们应用于未来的事件或发展。

References:

参考文献：

Feigin VL, et al. World Stroke Organization (WSO): global stroke fact sheet 2022. International Journal of Stroke. 2022 Jan;17(1):18-29.

Feigin VL 等。世界中风组织 (WSO)：2022年全球中风事实清单。《国际中风杂志》。2022年1月；17(1):18-29。

Feigin VL, et al. Pragmatic Solutions to Reduce Global Burden of Stroke. Lancet Neurol. 2023;22:1160–1206.

Feigin VL, 等。减少全球中风负担的实用解决方案。《柳叶刀神经病学》。2023年；22:1160–1206。

Kolmos M, et al. Recurrent ischemic stroke–a systematic review and meta-analysis. Journal of Stroke and Cerebrovascular Diseases. 2021 Aug 1;30(8):105935.

Kolmos M 等。复发性缺血性卒中——系统评价与荟萃分析。《卒中与脑血管疾病杂志》。2021年8月1日；30（8）：105935。

Rochmah TN, et al. Economic burden of stroke disease: a systematic review. International journal of environmental research and public health. 2021 Jul 15;18(14):7552.

Rochmah TN 等。中风疾病的经济负担：一项系统综述。《国际环境研究与公共卫生杂志》。2021年7月15日；18(14):7552。

Skajaa N, et al. Risks of stroke recurrence and mortality after first and recurrent strokes in Denmark: a nationwide registry study. Neurology. 2022 Jan 25;98(4):e329-42.

Skajaa N, 等。丹麦首次和复发性卒中后的卒中复发和死亡风险：一项全国登记研究。《神经病学》。2022年1月25日；98（4）：e329-42。

Contacts

联系人

Anne Jorgal

安妮·乔加尔

New Therapeutic Areas, Cardiology

新治疗领域，心脏病学

anne.jorgal@bayer.com

+49 30 2215-41592

Contact for investor inquiries: Bayer Investor Relations Team

投资者咨询请联系：拜耳投资者关系团队

ir@bayer.com