China approves Bayer’s asundexian after 26% reduction in ischemic stroke
Key Facts
China’s National Medical Products Administration granted Bayer marketing authorization for asundexian, to be sold as Sunharbo, on October 26, 2026. The drug is the first factor XIa inhibitor to receive marketing approval anywhere in the world, according to the company. The authorization is intended to reduce stroke risk in adults after a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack. The drug is taken orally at a dose of 50 mg once daily. The approval is based on the OCEANIC-STROKE trial, which showed a relative reduction of 26% in ischemic stroke compared with placebo.
The hazard ratio for ischemic stroke was 0.74, with a 95% confidence interval of 0.65 to 0.84, according to trial results announced by Bayer. The study included 12,327 participants worldwide and was randomized, placebo-controlled, double-blind and multicenter. The primary efficacy measure was time to ischemic stroke. In a secondary outcome, a stroke of any type was recorded in 6.6% of participants who received asundexian. The rate was 8.8% among those who received placebo.
On safety, major bleeding under criteria set by the International Society on Thrombosis and Haemostasis was recorded in 1.9% of participants who received asundexian, compared with 1.7% on placebo. The hazard ratio was 1.10, with a 95% confidence interval of 0.85 to 1.44. Bayer said the rate of major bleeding did not increase with the drug compared with placebo. The figures show similar rates of this specific category of bleeding in the two groups. Lead investigator Mike Sharma said the results showed a "meaningful reduction in stroke risk with asundexian compared with placebo."
The approval comes in a market facing a growing burden of ischemic stroke: its prevalence in China rose 10% between 2010 and 2021, reaching 20.80 million cases in 2021, according to Bayer. Globally, about one in 10 survivors of a non-cardioembolic ischemic stroke has another stroke within a year. The company said this occurs despite available secondary prevention strategies. In April 2026, Bayer said it looked forward to engaging with regulators to assess the drug’s potential role in secondary stroke prevention. The Chinese authorization places asundexian among newly approved options for this patient group.
China’s regulatory process began when the Center for Drug Evaluation of the National Medical Products Administration announced that it had accepted the marketing application on April 29, 2026. The center granted the application priority review before the authorization was issued. Bayer said marketing applications in additional markets worldwide remain under review. The Chinese approval announcement did not specify when decisions in those markets would be made. Bayer also did not announce when the drug would become available in China or its price.
The approval comes as sales of one of Bayer’s main anticoagulant drugs decline. Global sales of Xarelto fell to 2,344 million euros in 2025 from 3,480 million euros in 2024, a reported decline of 32.6%. The company attributed the decrease to patent expiries and competition from generics. By contrast, Bayer’s pharmaceutical division sales, adjusted for currency and portfolio effects, rose 1.7% to 17,829 million euros in 2025. The company noted that Xarelto’s decline following patent expiries was one of the factors weighing on performance. The Chinese authorization adds a new drug to Bayer’s pharmaceutical portfolio, while its applications in other markets remain under review.