NMPA Approves Bayer's Asundexin for Secondary Prevention of Non-Cardioembolic Ischemic Stroke or High-Risk TIA

Competition in the FXIa inhibitor space for stroke secondary prevention already involves several clinical programs. Bayer's OCEANIC-STROKE is a global pivotal Phase 3 randomized, quadruple-group study comparing asundexian with placebo in secondary prevention after acute ischemic stroke or high-risk transient ischemic attack; its primary endpoints include time to first occurrence of ischemic stroke and ISTH major bleeding over up to 31 months. Planned or actual enrollment was 12327 participants, the sponsor is Bayer, and the study is COMPLETED with primary completion on 2025-10-23 [regulatory filing · A]. In atrial fibrillation stroke prevention, Johnson & Johnson/BMS has conducted the global Phase 3 LIBREXIA AF study comparing milvexian with apixaban, designed to establish whether milvexian is at least as effective as apixaban on the composite stroke and non-central nervous system systemic embolism endpoints [company disclosure · G]. Another study compares milvexian versus apixaban for stroke prevention in atrial fibrillation, with the selected milvexian dose of 100 mg twice daily being 4-fold higher than the 50 mg daily dose of asundexian studied in OCEANIC AF [peer-reviewed · D]. A concurrent publication also indicates that a daily dose of 50 mg of asundexian is supported by clinical evidence in patients with noncardioembolic ischemic stroke or high-risk TIA receiving antiplatelet therapy [peer-reviewed · C].

On October 26, NMPA approved Bayer's asundexian (舒华博) marketing application for reducing the risk of recurrence in patients with noncardioembolic ischemic stroke or high-risk TIA; only about half a year elapsed from acceptance to approval, making it a global first launch in China for an FXIa inhibitor. The core data supporting approval come from OCEANIC-STROKE: asundexian reduced stroke recurrence risk by 26%, with major bleeding occurring in 1.9% versus 1.7% in the placebo arm. OCEANIC-STROKE enrolled 12000 patients globally, including 1451 in China; the media-exclusive Chinese subgroup showed a 32% reduction in recurrence risk, above the overall global reduction of 26%. The disease burden provides additional context: in 2023, approximately 4.23 million new stroke cases and about 2.05 million stroke deaths were reported in China. The concurrent record shows primary completion on 2025-10-23 and a COMPLETED status [regulatory filing · A]（新闻称 12000 例，注册库为 12327 例） (needs verification)。

What this advances is the indication setting and the commercialization path: asundexian is positioned as an add-on layer on top of existing antiplatelet therapy to further lower residual recurrence risk, with label boundaries excluding cardioembolic embolism and excluding entry into the atrial fibrillation anticoagulation market; the same molecule previously terminated a Phase 3 atrial fibrillation trial in late 2023 after failing against apixaban, and has now obtained approval in China for noncardioembolic stroke. Commercialization requires clearing three hurdles: whether neurology guidelines formally recommend long-term antiplatelet plus FXIa inhibition combination therapy, how price negotiation balances the modest NNT (absolute risk reduction of about 1.9%), and the rebuilding of channels — rivaroxaban's core territory is cardiology, whereas asundexian's reach centers on stroke centers and neurology DTP networks. Among subsequent competitors, milvexian is conducting a Phase 3 study in noncardioembolic stroke secondary prevention [company disclosure · F] (needs verification).

Information not yet disclosed includes the full statistical results and publication details of the Chinese subgroup, specific pricing and reimbursement negotiation arrangements, guideline recommendation progress, post-launch real-world data, and early sales performance; no timetable for these is provided. Subsequent milestones depend mainly on access and uptake of asundexian in China, Phase 3 progress by milvexian in noncardioembolic stroke and atrial fibrillation stroke prevention, and clinical outcomes for abelacimab in stroke prevention.

对账：NCT05686070 新闻称 12000、注册库为 12327；NCT05419635 新闻称 12000、注册库为 27；NCT05419635 新闻称 12327、注册库为 27。

Some figures were not confirmed in primary records and need verification: 数字 26 未追到一手，未标媒体独有; 数字 1.9 未追到一手，未标媒体独有; 数字 1.7 未追到一手，未标媒体独有; 数字 1451 未追到一手，未标媒体独有.