NMPA Approves Bayer's Asundexian to Reduce Stroke Risk in Adults with Non-Cardioembolic Ischemic Stroke or High-Risk TIA

Before this approval, Bayer's oral FXIa inhibitor asundexian remained an investigational compound that had not been approved by any health authority in any country for any indication ^[1]. The drug had previously received Fast Track designation from the FDA as a potential treatment for stroke prevention (as reported) ^[2], and was reportedly not yet FDA approved ^[3]. Its pivotal phase 3 OCEANIC-STROKE study (NCT05686070) was designed to test whether adding asundexian to standard therapy reduces recurrent stroke risk in patients with recent noncardioembolic ischemic stroke ^[4], with results published in the New England Journal of Medicine.

On October 26, 2026, Bayer's asundexian tablets (brand name 舒华博®) were approved by China's NMPA, once-daily oral, to reduce stroke risk in adults with noncardioembolic ischemic stroke or high-risk TIA, excluding cardioembolic stroke patients. China became the first approval market for the drug (as reported) ^[5]. The basis was OCEANIC-STROKE: among 12,327 randomized patients (6162 asundexian, 6165 placebo), adding asundexian 50 mg once daily on top of single or dual antiplatelet therapy reduced ischemic stroke incidence to 6.2% vs 8.4%, cause-specific hazard ratio 0.74 (95% CI 0.65-0.84, P<0.001) [同行评审·I], without increased major bleeding [同行评审·I] (needs verification)。

Relative to prior materials, the decisive step is regulatory: previously an investigational compound with no approvals ^[1], the drug has now reached market first in China. On mechanism, the accompanying paper only states that low factor XI levels are associated with reduced ischemic stroke risk, that asundexian inhibits activated factor XI, and that whether adding it to antiplatelet therapy would be superior to antiplatelet therapy alone was previously unclear [同行评审·I]; this trial answered affirmatively. This moves secondary stroke prevention from conventional antiplatelet regimens toward FXIa-targeted intervention, with China's review moving ahead of the FDA (which reportedly has not approved) ^[3].

Undisclosed information includes pricing and reimbursement arrangements, the current status and timeline of FDA review, and any plans to extend the indication to cardioembolic stroke—all to be confirmed. Future milestones include the FDA decision on the marketing application and readouts of other OCEANIC program studies.