China Approves Bayer's Asundexian, the World's First FXIa Inhibitor, for Stroke Prevention
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On October 26, 2026, China's NMPA granted the world's first approval of Bayer's oral Factor XIa inhibitor asundexian (brand name Shuhuabo), via priority review, roughly six months after acceptance. The drug is approved to reduce stroke risk in adults after non-cardioembolic ischemic stroke or high-risk transient ischemic attack, taken once daily; cardioembolic stroke patients are excluded. The approval rests on the global Phase III OCEANIC-STROKE trial, in which 12,327 patients followed for a median of 19 months showed recurrent ischemic stroke rates of 6.2% versus 8.4% in the control group — a 26% relative reduction globally and 32% in the Chinese subgroup — with major bleeding rates of 1.9% versus 1.7% for placebo. China is the first launch market; filings were also made in the United States and Japan, where decisions are still pending.
Written by a model from the reports · updated 2 hours ago
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- mp.weixin.qq.comBayer's Asundexian Approved in China to Reduce Stroke Risk After Ischemic Stroke or High-Risk TIA
Bayer's oral FXIa inhibitor Asundexian has been approved in China through the priority review pathway to reduce stroke risk in adults after ischemic stroke or high-risk transient ischemic attack (TIA). The indication excludes patients with cardioembolic stroke, and the approval is based primarily on results of the global Phase III OCEANIC-STROKE trial. The drug targets activated factor XI (FXIa) to reduce pathological thrombus formation.
- mp.weixin.qq.comPickNMPA Approves Bayer's Asundexian to Reduce Stroke Risk in Adults with Non-Cardioembolic Ischemic Stroke or High-Risk TIA
Bayer's asundexian tablets were approved by China's NMPA on October 26, 2026, to reduce stroke risk in adults with non-cardioembolic ischemic stroke or high-risk TIA. The drug is taken orally once daily, and its indication excludes patients with cardioembolic stroke.
- mp.weixin.qq.comBayer FXIa Inhibitor Asundexian Approved in China for Secondary Prevention After Ischemic Stroke or TIA
On October 26, the NMPA approved Bayer's FXIa inhibitor Asundexian for secondary prevention in adults after non-cardioembolic ischemic stroke or high-risk TIA.
- mp.weixin.qq.comBayer FXIa Inhibitor Asundexian Wins First Approval in China for Stroke Management
Bayer's Factor XIa inhibitor Shuhuabo (asundexian tablets) has been approved in China, a world first, for stroke management. The materials call it a first-in-class drug and describe the underlying research as the first Phase III stroke study of a FXIa inhibitor to successfully complete with positive results. In 2023 China recorded about 4.23 million new stroke cases, 26.68 million prevalent cases and 2.05 million stroke deaths, and stroke remains a major public health challenge.
- mp.weixin.qq.comNMPA Approves Bayer's Asundexin for Secondary Prevention of Non-Cardioembolic Ischemic Stroke or High-Risk TIA
The NMPA has approved Bayer's asundexin to reduce recurrence risk in patients with non-cardioembolic ischemic stroke or high-risk TIA, with China as the drug's global first launch market. Supporting data come from the global pivotal Phase III OCEANIC-STROKE trial, which showed recurrence risk fell 26% globally and 32% in the Chinese subgroup, with major bleeding rates of 1.9% versus 1.7% for placebo.
- mp.weixin.qq.comChina Approves Bayer's Asundexian, the World's First Authorized FXIa Inhibitor
On October 26, China's NMPA approved asundexian tablets, developed by Bayer, making China the first country to authorize the world's first approved FXIa inhibitor. The approval is based on the global Phase III OCEANIC-STROKE trial, in which 12,327 patients followed for a median of 19 months showed recurrent ischemic stroke rates of 6.2% with added asundexian versus 8.4% in the control group, a 26% relative reduction.
- mp.weixin.qq.comBayer FXIa Inhibitor Asundexian Approved in China for Non-Cardioembolic Stroke Recurrence Prevention
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.
- mp.weixin.qq.comNMPA approves Bayer Class 1 FXIa inhibitor for ischemic stroke recurrence prevention, a world first
China's NMPA has approved, via priority review, the Class 1 innovative drug from Bayer AG indicated to reduce stroke risk in adults with ischemic stroke or high-risk transient ischemic attack (TIA), excluding patients with cardioembolic stroke. It is the world's first approved FXIa inhibitor for preventing recurrent ischemic stroke. Marketing applications were also filed with the FDA.
- weixin.sogou.comPickNMPA Grants World-First Approval to Bayer's Asundexian to Reduce Ischemic Stroke or High-Risk TIA Risk
The NMPA has granted the world's first approval of Bayer's asundexian to reduce stroke risk in adults with ischemic stroke or high-risk transient ischemic attack (TIA), excluding cardioembolic stroke. The drug received priority review, with approval taking about half a year from acceptance.
- mp.weixin.qq.comBayer's Asundexian Approved by NMPA to Reduce Stroke Risk in Adults with Ischemic Stroke or High-Risk TIA
Bayer's asundexian (brand name Shuhuabo) has been approved by China's NMPA to reduce stroke risk in adults with ischemic stroke or high-risk TIA, excluding patients with cardioembolic stroke. The original article says that as a Factor XIa inhibitor, asundexian can in theory reduce clot formation and thereby lower the risk of vessel narrowing or blockage without markedly raising the risk of major bleeding. In 2026, filings were launched in China, the United States and Japan, with China approving it first.
- mp.weixin.qq.comBayer's First-in-Class Asundexian Wins China Approval, With Three-Tier Launch Plan
Bayer's first-in-class drug asundexian has been approved in China ahead of other markets, and the article focuses on its positioning in secondary stroke prevention. The regimen is described as moving from antiplatelet monotherapy toward antiplatelet plus targeted anticoagulation. A subsequent commercialization strategy has three tiers, but the article does not detail them.
- mp.weixin.qq.comNMPA Approves Bayer's Asundexian to Reduce Stroke Risk After Ischemic Stroke or High-Risk TIA
China's NMPA has approved, through priority review, the Class 1 innovative drug asundexian tablets (Chinese brand name Shuhuabo), filed by Bayer AG. The drug reduces stroke risk in adults with ischemic stroke or high-risk transient ischemic attack (TIA), excluding cardioembolic stroke patients.
- mp.weixin.qq.comChina NMPA Approves Bayer's Asundexin Tablets to Reduce Stroke Risk in Adults After Ischemic Stroke or High-Risk TIA
China's National Medical Products Administration has approved, through priority review, Asundexin Tablets, a Class 1 innovative drug from Bayer AG, marketed under the brand name Shuhuabo. The drug reduces stroke risk in adults with ischemic stroke or high-risk transient ischemic attack (TIA), excluding patients with cardioembolic stroke.
- mp.weixin.qq.comNMPA Approves Bayer's Asundexian, World's First Factor XIa Inhibitor, First Globally in China
Bayer's asundexian has been approved by China's NMPA to reduce stroke risk in adults with ischemic stroke or high-risk transient ischemic attack (TIA), marking the drug's first approval worldwide. The indication excludes patients with cardioembolic stroke. The application received priority review and was approved roughly six months after acceptance.
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