Bayer receives Chinese approval for blood thinner Asundexian

China's National Medical Products Administration (NMPA) has approved Bayer's blood thinner, Asundexian (brand name Sunharbo), for the prevention of secondary ischemic strokes. This marks the first approval in China for the new class of FXIa inhibitors, which target the FXIa protein involved in blood clot formation.

Asundexian is positioned as a potential successor to Bayer's former blockbuster drug, Xarelto, which has faced increasing competition from generic alternatives. Analysts, including those from Morgan Stanley, have identified the drug as a potential blockbuster with peak sales potential reaching up to 4 billion euros.

Clinical trial data from the Oceanic-Stroke study, involving over 12,000 patients, indicated that Asundexian significantly reduced the risk of ischemic stroke compared to a placebo, with a 6.2% occurrence rate versus 8.4% in the placebo group. The study also noted that strokes in the treatment group were less likely to be moderate to severe, without a significant increase in severe bleeding rates.