China Approved Bayer’s Asundexian, the First Factor XIa Inhibitor, on a 26% Stroke Reduction, Three Years After It Lost to Apixaban
Bayer said on 26 October that China’s National Medical Products Administration had approved asundexian, sold as Sunharbo at 50 mg once daily, to reduce the risk of stroke in adults after a non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack. Bayer calls it the first factor XIa inhibitor approved anywhere. The approval followed priority review and rests on OCEANIC-STROKE, a Phase III trial in 12,327 patients that added asundexian or placebo to antiplatelet therapy and cut ischaemic stroke by 26% with no increase in major bleeding, published in the New England Journal of Medicine in April. The US FDA accepted the application under priority review in May, and Japan’s health ministry is reviewing it.
Bayer holds the first factor XIa approval anywhere, in secondary stroke prevention, three years after the same drug lost to apixaban in atrial fibrillation. The class has narrowed to the setting where it is added to antiplatelets rather than replacing an anticoagulant, and there asundexian now leads. Bristol Myers Squibb and Johnson & Johnson expect milvexian’s stroke and atrial fibrillation readouts in 2026, after stopping its acute coronary syndrome trial in November 2025.
- Bristol Myers Squibb and Johnson & Johnson: milvexian has a benchmark to beat. LIBREXIA-STROKE will be read against a 26% reduction with no rise in major bleeding, and anything weaker leaves milvexian second in the one setting where the class has worked. A win in LIBREXIA-AF, where asundexian failed, would give milvexian the anticoagulation market Bayer could not reach.
- Stroke prescribers in China: an add-on to cheap generics. Sunharbo is approved on top of single or dual antiplatelet therapy, so it adds a branded drug to regimens built on generics. An absolute reduction of about two percentage points in ischaemic stroke has to justify a long-term daily cost, which makes price and reimbursement the real launch test.
- Signposts: the FDA decision, LIBREXIA-STROKE and the reimbursement list. Watch for the FDA decision on the priority review accepted in May, the milvexian stroke topline promised for 2026, and the price Bayer sets in China ahead of a national reimbursement drug list negotiation.
Read the original source (Bayer) →
Read the US and Japan filings (Bayer) →
Read the trial results (Population Health Research Institute) →
Read the milvexian programme update (Bristol Myers Squibb) →