China Approves Bayer’s Asundexian After 26% Reduction in Ischemic Stroke

Key Facts

China has granted Bayer marketing approval for Asundexian to reduce the risk of stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. The drug is given alongside antiplatelet therapy, in line with the scope of use set out in the approval. The decision is based on results from the Phase III OCEANIC-STROKE trial, which showed a 26% reduction in ischemic stroke compared with placebo when both were used with antiplatelet therapy. Christian Rommel, head of research and development in Bayer’s pharmaceuticals division, said the company is working with stakeholders and medical communities to support timely and equitable access to treatment for eligible patients in China. The approval moves the drug into commercial use in China for a defined group of secondary-prevention patients.

The study tested Asundexian at a dose of 50 mg once daily, alongside antiplatelet therapy, against placebo added to the same therapy. Bayer describes the drug as inhibiting activated factor XI in the blood-clotting pathway. The company says the factor has roles in hemostasis and thrombosis, and a limited role in forming the hemostatic plug that stops bleeding when a vessel is injured. On that basis, the trial result does not mean the drug is free of bleeding risks or safer than all available treatments. The clinical comparison was with placebo, not with every treatment used to prevent stroke.

On safety results, Bayer said the trial found no increase in major bleeding, as defined by the International Society on Thrombosis and Haemostasis, compared with placebo. This result is limited to the major-bleeding category measured under that definition and does not establish that there was no increase in every bleeding category. The trial also showed a 26% reduction in the risk of stroke of any type, ischemic or hemorrhagic. Stroke of any type was recorded in 6.6% of participants who received Asundexian, compared with 8.8% of those who received placebo.

The OCEANIC-STROKE trial included 12,327 participants worldwide and was designed as a multicenter, randomized, placebo-controlled, double-blind study. Bayer says the prevalence of ischemic stroke in China increased 10% between 2010 and 2021, reaching 20.80 million cases in 2021. The company also says about one in 10 survivors of a non-cardioembolic ischemic stroke may have another stroke within a year, despite available secondary-prevention strategies. Bayer submitted an application to market Asundexian to China’s Center for Drug Evaluation on April 29, 2026, based on the study results. On May 7, 2026, the application received priority review status from the center, before the marketing approval was issued.

The drug’s regulatory path extends to other markets, but applications there remain under regulatory review, according to the available facts. On May 19, 2026, Bayer said the U.S. Food and Drug Administration had accepted its application and granted it priority review, while Japan’s Ministry of Health, Labour and Welfare had also accepted the marketing application. These steps do not mean approval has been issued in the United States or Japan. In trading, Bayer’s stock, listed under the symbol BAYRY, closed at $12.32 on October 23, 2026, down from $12.40 in the previous session. The stock had closed at $12.12 on October 19, then at $12.50 on October 21, before its latest recorded close.