Bayer’s asundexian (Sunharbo) approved in China to reduce recurrent ischemic stroke risk

Regulatory approval in China

China’s National Medical Products Administration (NMPA) granted marketing authorization for asundexian, marketed as Sunharbo, as a once‑daily 50 mg oral therapy indicated to reduce the risk of stroke in adults after a non‑cardioembolic ischemic stroke or high‑risk transient ischemic attack (TIA). Sunharbo is the first Factor XIa (FXIa) inhibitor approved worldwide.

Clinical evidence

The approval is based on the global Phase III OCEANIC‑STROKE study, which randomized 12,327 participants and used time to ischemic stroke as the primary efficacy endpoint and ISTH major bleeding as the primary safety endpoint. Results showed asundexian 50 mg in combination with dual or single antiplatelet therapy reduced ischemic stroke by 26% versus antiplatelet therapy alone, with a similar incidence of all bleeding events between groups; treatment effects were consistent across key subgroups. Full results were published in The New England Journal of Medicine.

Mechanism and indication

Factor XIa is implicated in pathological thrombus growth while playing a minor role in normal hemostasis. Asundexian selectively inhibits FXIa to reduce pathological clot formation, aiming to uncouple thrombosis reduction from increased bleeding risk.

Regulatory status and next steps

Bayer has submitted asundexian for marketing authorization in additional markets and reports those applications are under review while it works with health authorities to seek broader availability.