Bayer's Stroke Prevention Drug Accepted in China
China's NMPA accepted Bayer's filing for asundexian, a Factor XIa inhibitor for stroke prevention in atrial fibrillation.
May 2, 2026
1 min read
27 views
Source: indianpharmapost.com
Image: indianpharmapost.com
Bayer announced on May 2, 2026, that China's National Medical Products Administration (NMPA) has accepted a new drug application for asundexian, an oral Factor XIa inhibitor aimed at preventing stroke in patients with atrial fibrillation.
The filing is based on results from the Phase III OCEANIC-AF trial, which demonstrated that asundexian reduced the risk of stroke and systemic embolism compared to standard therapy, with a lower bleeding risk. The trial enrolled over 14,000 patients globally, including sites in China.
Asundexian is part of a new class of anticoagulants that target Factor XIa, potentially offering a safer alternative to current treatments like apixaban. Bayer is also seeking approval in other regions, including the European Union and the United States.
❓ Frequently Asked Questions
What is asundexian?
Asundexian is an oral Factor XIa inhibitor developed by Bayer to prevent stroke in patients with atrial fibrillation, with a potentially lower bleeding risk than current anticoagulants.
What did the OCEANIC-AF trial show?
The Phase III OCEANIC-AF trial showed that asundexian reduced stroke and systemic embolism risk with a lower bleeding risk compared to standard therapy, involving over 14,000 patients globally.
Is asundexian approved in other countries?
As of May 2, 2026, asundexian has been accepted for review in China, and Bayer is pursuing approvals in the European Union and the United States.
