Bayer Gets in China Its First Global Approval for Stroke Prevention Drug
By Adria Calatayud
Bayer said it received regulatory authorization to launch a new drug to prevent recurrent stroke in China, winning the first global approval for a new class of medicines.
The German pharmaceutical group said the decision from China's National Medical Products Administration hands it the first approval worldwide for a class of drugs called Factor XIa inhibitors, which aim to slow down the activity of a protein that regulates how the body forms clots without increasing the risk of bleeding.
The drug, known until now as asundexian, will be marketed under the brand name Sunharbo, Bayer said Monday.
The company said the medicine was approved to reduce the risk of stroke in adults after an after noncardioembolic ischemic stroke or high-risk transient ischemic attack--when the blood supply to the brain is disrupted.
The Chinese approval followed a priority review and was based on positive data from a pivotal study, Bayer said.
Further regulatory applications are currently under review around the world, the company added.
Write to Adria Calatayud at adria.calatayud@wsj.com
(END) Dow Jones Newswires
October 26, 2026 04:58 ET (08:58 GMT)
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