China 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.