
This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, any securities. There will be no public offer of the securities in any jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. An investment decision regarding the securities referred to herein should only be made on the basis of the securities prospectus.
This announcement is an advertisement and does not, under any circumstances, constitute a public offering or an invitation to the public in connection with any offer within the meaning of Regulation (EU) 2017/1129. The final prospectus, when published, will be available on the website of the Luxembourg Stock Exchange (www.luxse.com).
The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. State security laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act or to, or for the benefit of, U.S. persons.
The tender offer referenced herein is not being made, directly or indirectly, in or into the United States by use of the mails or by any means or instrumentality (including, without limitation, e-mail, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or of any facility of a national securities exchange of the United States and the tender offer cannot be accepted by any such use, means, instrumentality or facility or from within the United States.
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The following materials are not directed at or to be accessed by persons located in the United States, Australia, Canada or Japan. These materials do not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in the United States, Australia, Canada or Japan or in any other jurisdiction in which such offer or solicitation is not authorized or to any person to whom it is unlawful to make such offer or solicitation.
The securities mentioned herein have not been, and will not be, registered under the Securities Act and may not be offered or sold in the United States, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There will be no public offer of the securities in the United States.
In the United Kingdom the following materials are only directed at (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (ii) high net worth companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). The securities are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on the materials or any of their contents.
In relation to each member state of the European Economic Area which has implemented the Directive 2003/71/EC, and any amendments thereto (the "Prospectus Directive")(each a "Relevant Member State"), an offer to the public of the securities has not been made and will not be made in such Relevant Member State, except that an offer to the public in such Relevant Member State of any securities may be made at any time under the following exemptions from the Prospectus Directive, if they have been implemented in the Relevant Member State:
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- to fewer than 150 natural or legal persons (other than qualified investors as defined in the Prospectus Directive), as permitted under the Prospectus Directive, or
- in any other circumstances falling within Article 3(2) of the Prospectus Directive;
provided that no such offer shall result in a requirement to publish a prospectus pursuant to Article 3 of the Prospectus Directive or supplement a prospectus pursuant to Article 16 of the Prospectus Directive.
For the purposes of this provision, the expression an "offer to the public" in relation to any securities in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and any securities to be offered so as to enable an investor to decide to purchase any securities, as the same may be varied in that Relevant Member State by any measure implementing the Prospectus Directive in that Relevant Member State, and the expression "Prospectus Directive" includes any relevant implementing measure in each Relevant Member State.
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Basis of accessAccess to electronic versions of these materials is being made available on this webpage by Bayer in good faith and for information purposes only. Making press announcements and other documents available in electronic format on this webpage does not constitute an offer to sell or the solicitation of an offer to buy securities issued by Bayer. Further, it does not constitute a recommendation by Bayer, or any other party to buy or sell securities issued by Bayer.
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This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, any securities. There will be no public offer of the securities in any jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. An investment decision regarding the securities referred to herein should only be made on the basis of the securities prospectus.
This announcement is an advertisement and does not, under any circumstances, constitute a public offering or an invitation to the public in connection with any offer within the meaning of Regulation (EU) 2017/1129. The final prospectus, when published, will be available on the website of the Luxembourg Stock Exchange (www.luxse.com).
The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. State security laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act or to, or for the benefit of, U.S. persons.
The tender offer referenced herein is not being made, directly or indirectly, in or into the United States by use of the mails or by any means or instrumentality (including, without limitation, e-mail, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or of any facility of a national securities exchange of the United States and the tender offer cannot be accepted by any such use, means, instrumentality or facility or from within the United States.
Viewing the materials you seek to access may not be lawful in certain jurisdictions. In other jurisdictions, only certain categories of person may be allowed to view such materials. Any person who wishes to view these materials must first satisfy themselves that they are not subject to any local requirements that prohibit or restrict them from doing so.
If you are not permitted to view materials on this webpage or are in any doubt as to whether you are permitted to view these materials, please exit this webpage.
Basis of accessAccess to electronic versions of these materials is being made available on this webpage by Bayer in good faith and for information purposes only. Making press announcements and other documents available in electronic format on this webpage does not constitute an offer to sell or the solicitation of an offer to buy securities issued by Bayer. Further, it does not constitute a recommendation by Bayer, or any other party to buy or sell securities issued by Bayer.
Confirmation of understanding and acceptance of disclaimerBy clicking on the "I AGREE" button, I certify that I am not located in the United States, Australia, Canada, South Africa or Japan or any other jurisdiction, where access to the materials is prohibited or restricted.
I have read and understood the disclaimer set out above. I understand that it may affect my rights. I agree to be bound by its terms. By clicking on the "I AGREE" button, I confirm that I am permitted to proceed to electronic versions of these materials.
This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, any securities. There will be no public offer of the securities in any jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. An investment decision regarding the securities referred to herein should only be made on the basis of the securities prospectus.
This announcement is an advertisement and does not, under any circumstances, constitute a public offering or an invitation to the public in connection with any offer within the meaning of Regulation (EU) 2017/1129. The final prospectus, when published, will be available on the website of the Luxembourg Stock Exchange (www.luxse.com).
The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. State security laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act or to, or for the benefit of, U.S. persons.
The tender offer referenced herein is not being made, directly or indirectly, in or into the United States by use of the mails or by any means or instrumentality (including, without limitation, e-mail, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or of any facility of a national securities exchange of the United States and the tender offer cannot be accepted by any such use, means, instrumentality or facility or from within the United States.
Viewing the materials you seek to access may not be lawful in certain jurisdictions. In other jurisdictions, only certain categories of person may be allowed to view such materials. Any person who wishes to view these materials must first satisfy themselves that they are not subject to any local requirements that prohibit or restrict them from doing so.
If you are not permitted to view materials on this webpage or are in any doubt as to whether you are permitted to view these materials, please exit this webpage.
Basis of accessAccess to electronic versions of these materials is being made available on this webpage by Bayer in good faith and for information purposes only. Making press announcements and other documents available in electronic format on this webpage does not constitute an offer to sell or the solicitation of an offer to buy securities issued by Bayer. Further, it does not constitute a recommendation by Bayer, or any other party to buy or sell securities issued by Bayer.
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This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, any securities. There will be no public offer of the securities in any jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction.
The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. State security laws and may not be offered or sold in the United States or to, or for the benefit of, U.S. persons absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act.
Viewing the materials you seek to access may not be lawful in certain jurisdictions. In other jurisdictions, only certain categories of person may be allowed to view such materials. Any person who wishes to view these materials must first satisfy themselves that they are not subject to any local requirements that prohibit or restrict them from doing so.
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Basis of accessAccess to electronic versions of these materials is being made available on this webpage by Bayer in good faith and for information purposes only. Making press announcements and other documents available in electronic format on this webpage does not constitute an offer to sell or the solicitation of an offer to buy securities issued by Bayer. Further, it does not constitute a recommendation by Bayer, or any other party to buy or sell securities issued by Bayer.
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This announcement is an advertisement and does not, under any circumstances, constitute a public offering or an invitation to the public in connection with any offer within the meaning of Regulation (EU) 2017/1129. The final prospectus, when published, will be available on the website of the Luxembourg Stock Exchange (www.luxse.com).
The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. State security laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act or to, or for the benefit of, U.S. persons.
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With this approval, asundexian will become the first Factor XIa inhibitor (FXIa) available in China, to reduce the risk of stroke in adults after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack / Regulatory approval follows the China's Center of Drug Evaluation's Priority Review designation and is based on positive data from the pivotal, global Phase III OCEANIC-STROKE study / Stroke is the leading cause of death and disability in China
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Berlin, October 26, 2026 - Bayer announced today that China's National Medical Products Administration (NMPA) has granted marketing authorization for asundexian, under the brand name Sunharbo®. Asundexian, 50 mg, a selective, once-daily oral Factor XIa inhibitor (FXIa), is indicated to reduce the risk of stroke in adults after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). Sunharbo® (asundexian) is the first FXIa inhibitor approved worldwide.
In China, stroke is the leading cause of death and disability. Between 2010 and 2021, the prevalence of ischemic stroke increased by 10% to more than 20 million ischemic stroke cases in China. Globally, approximately 1 in 10 non-cardioembolic ischemic stroke survivors experience another stroke within one year, even with available secondary stroke prevention strategies.
"With the approval of asundexian, we have reached an important milestone and are proud soon to be able to offer physicians in China a new treatment option for stroke survivors after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. This enables us to address an unmet need with limited therapeutic advances over the past two decades," said Christian Rommel, Ph.D., Global Head of Research and Development at Bayer`s Pharmaceuticals Division. "We are working with stakeholders and medical communities to support equitable and timely access for eligible patients in China."
Asundexian has been submitted for marketing authorization in additional markets around the world. These applications are currently under review, while Bayer continues to work with health authorities worldwide to bring asundexian to patients in other regions.
Key Clinical Trial Findings Supporting Approval
The approval by China's National Medical Products Administration (NMPA) is based on positive data from the pivotal, global Phase III OCEANIC-STROKE study, the first successfully completed Phase III study of a Factor XIa inhibitor in combination with dual antiplatelet therapy (DAPT) / single antiplatelet therapy (SAPT) demonstrating superiority in reducing ischemic stroke, compared to DAPT/SAPT alone. The incidence of all bleeding events was similar between the two treatment groups, in patients after a non-cardioembolic stroke or high-risk TIA. Key findings demonstrated:
- Asundexian 50 mg in combination with DAPT/SAPT, significantly reduced ischemic stroke by 26% in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), compared to DAPT/SAPT alone.
- The incidence of all bleeding events was similar between the two treatment groups.
- Treatment effect for the primary endpoint was consistent across key subgroups (including age, sex, type of index event, non-cardioembolic stroke subtypes, stroke severity, and planned antiplatelet therapy) supporting its potential use across a broad patient population.
- The full results from OCEANIC-STROKE have been published in The New England Journal of Medicine
About OCEANIC-STROKE
The Phase III OCEANIC-STROKE study investigated the efficacy and safety of the selective, once-daily oral Factor XIa inhibitor asundexian 50 mg in combination with DAPT/SAPT, compared to DAPT/SAPT alone, for risk reduction of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). OCEANIC-STROKE is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that randomized 12,327 participants worldwide. The primary efficacy endpoint was time to ischemic stroke; the primary safety endpoint was ISTH (International Society on Thrombosis and Hemostasis) major bleeding.
About FXIa Inhibitors and Asundexian
Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. FXIa is thought to contribute to the formation of pathological thrombus growth and vessel blockage. However, FXIa has a minor role in the formation of a hemostatic plug that seals the leak at the site of vessel injury.
Asundexian is the first approved FXIa inhibitor worldwide. It selectively inhibits FXIa, allowing to reduce pathological clot formation, with similar incidence of all bleeding events between the two treatment groups, by uncoupling hemostasis from pathological thrombosis.
About Bayer's Commitment in Cardiovascular and Cerebrovascular Medicine
Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) and cerebrovascular diseases of high unmet medical need. The company has set a clear focus on developing therapies to treat such 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. Bayer is actively shaping the future of cardiology and neurology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. Bayer's portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development.
About Bayer
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 support efforts to master major challenges presented by a growing and aging global population and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go towww.bayer.com.
Find more information athttps://pharma.bayer.com
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Forward-Looking Statements
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. These factors include those discussed in Bayer's public reports which are available on the Bayer website atwww.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
Bayer AG is a holding company with operating subsidiaries worldwide. References to "Bayer" or "the company" herein may refer to one or more subsidiaries as context requires.
Astrid Kranz
Head of Communication Key Therapeutic Areas
astrid.kranz@bayer.com |
Jutta Schulze
Cardiology, Ophthalmology, Hemophilia
jutta.schulze@bayer.com |
Contact for investor inquiries: Bayer Investor Relations Team
ir@bayer.com |
- 2026-0184e.pdf
- 2026-0184e.rtf

