Bayer Stroke Drug Gets China Approval

By the Editorial Team · Tuesday, October 27, 2026

Bayer received China's first approval for asundexian, a Factor XIa inhibitor designed to prevent recurrent strokes in adults with noncardioembolic ischemic stroke or high-risk transient ischemic attack. The drug’s favorable balance of reducing stroke risk without increasing major bleeding could set a new standard in stroke prevention and give Bayer a competitive lead before similar therapies enter the market.

Bayer has received regulatory approval in China for asundexian, a drug designed to prevent recurrent strokes, marking the first global authorization for a new class of blood-thinning medications called Factor XIa inhibitors. The German pharmaceutical company announced Monday that China’s National Medical Products Administration authorized the drug, which will be marketed under the brand name Sunharo.

The approval covers use in adults who have experienced a noncardioembolic ischemic stroke or a high-risk transient ischemic attack, conditions where the blood supply to the brain is interrupted. Stroke remains the leading cause of death and disability in China. Bayer secured the nod following a priority review based on positive results from a pivotal late-stage clinical trial.

That study, disclosed last November, found that asundexian, when combined with antiplatelet therapy, lowered the risk of recurrent stroke without significantly increasing the risk of major bleeding. The trial’s outcome provided a regulatory pathway despite an earlier setback when the drug failed a stroke prevention study in patients with atrial fibrillation.

Asundexian aims to inhibit Factor XIa, a protein involved in blood clot formation, offering a potential advantage by reducing clotting without elevating bleeding risk—a common complication of existing blood thinners. Bayer highlighted this mechanism as a differentiating factor that could establish a new standard for efficacy and safety in stroke prevention.

Christine Roth, head of global product strategy and commercialization for Bayer’s pharmaceuticals division, indicated that the approval positions asundexian to lead the market, expecting a head start of about one year before competitors’ similar drugs become available. She emphasized the drug’s balance of effectiveness and low bleeding risk as setting a high bar for rival products.

In addition to China, Bayer stated that regulatory evaluations for asundexian are underway in other regions worldwide. The company views the drug as a strategic asset to offset declining sales of its blockbuster anticoagulant Xarelto, which recently lost patent protection.

This article was reported by synthesizing coverage from multiple independent news outlets to present a balanced, unbiased account. Read about our editorial standards. Spotted an error? Let us know.