Health · Pharma & Biotech · 1 hr ago
China approves Bayer’s Asundexian to help prevent strokes
China has approved Bayer’s drug Asundexian to help prevent another stroke in certain patients.
The medicine, sold under the name Sunharbo, is for people who have had a cardioembolic ischaemic stroke or a high-risk transient ischaemic attack.
It is the first FXIa-inhibitor drug approved in China, a new class of medicines that targets a protein involved in blood-clot formation.
In a study, Asundexian combined with medicines that prevent platelets clumping reduced the risk of ischaemic stroke in patients with a previous stroke.
The study found no rise in major bleeding compared with a placebo.
The approval gives Bayer a potential successor to Xarelto, whose sales face competition from generic medicines after patent expiries.
A US accelerated review is also under way, and its result is expected soon.
China’s NMPA has approved Bayer’s Asundexian, marketed as Sunharbo, to help prevent strokes in certain patients.
It is approved for people who have had a cardioembolic ischemic stroke or a high-risk transient ischemic attack.
Asundexian is the first FXIa inhibitor approved in China.
Bayer said the approval followed an accelerated review based on results from the Oceanic-Stroke study.
The articles say the drug reduced ischemic stroke risk when used with antiplatelet treatment, without an increase in major bleeding compared with placebo.
- Who
- Bayer and China’s National Medical Products Administration (NMPA).
- What
- China approved Asundexian, marketed as Sunharbo, for stroke prevention in specified patients.
- When
- The approval was announced on Monday; the articles were published on October 26, 2026.
- Where
- China.
- Why
- To help prevent strokes in patients who have previously had a cardioembolic ischemic stroke or a high-risk transient ischemic attack.
This story does not have two clearly opposing sides.
Bayer reported that Asundexian was under an accelerated approval process in China.
Bayer ended a Phase III study of Asundexian in patients with atrial fibrillation and stroke risk after it failed.
The articles reported that China had approved Asundexian for stroke prevention.
- Brand name
- Sunharbo
- Drug class
- FXIa inhibitor
- Study
- Oceanic-Stroke
- Approval authority
- China’s NMPA
- Eligible patients
- Those with a prior cardioembolic ischemic stroke or high-risk transient ischemic attack