mp.weixin.qq.com·· 9 hours agoPickScore82
Bayer FXIa Inhibitor Asundexian Approved in China for Non-Cardioembolic Stroke Recurrence Prevention
In brief
China's National Medical Products Administration has approved Bayer's Asundexian through priority review, making it the world's first approved activated factor XI (FXIa) inhibitor. The drug reduces stroke risk in adults after ischemic stroke or high-risk transient ischemic attack (TIA), excluding cardioembolic stroke patients. Approval took about half a year from filing to clearance.
Why it matters
Marks the world's first FXIa inhibitor approval, with priority-review timing and indication exclusions, to clarify regulatory context and applicable boundaries.
Source: mp.weixin.qq.com · mp.weixin.qq.com