China's National Medical Products Administration has granted approval for Bayer AG's blood thinner Asundexian, to be marketed as Sunharbo, marking the first global approval for a Factor XIa inhibitor. The decision follows clinical trials demonstrating a 26% reduction in secondary stroke risk without increased serious bleeding. The approval provides a key boost to Bayer's pharmaceutical unit as it faces generic competition for older drugs like Xarelto in a market where stroke is the leading cause of death.
China approves Bayer's Asundexian
- ▪The approval of Asundexian by China's National Medical Products Administration followed a priority review designation granted in May 2026 as an accelerated process for urgent medical needs
- ▪China's National Medical Products Administration approved Bayer's blood thinner Asundexian, marketed under the brand name Sunharbo, to reduce recurrent stroke risk in adults on October 26, 2026
Clinical trial results for Asundexian
- ▪Recurrent strokes that occurred in patients receiving Asundexian during clinical testing were less likely to be moderate to severe compared to placebo
- ▪In a late-stage clinical trial of 12,327 patients, adding Asundexian to standard antiplatelet therapy reduced secondary stroke risk by 26%, with 6.2% suffering ischaemic stroke versus 8.4% in the placebo group
Mechanism and safety of Asundexian
- ▪The Factor XIa protein-blocking mechanism of Asundexian target blood clotting without increasing the risk of serious bleeding when added to standard antiplatelet therapy
- ▪Asundexian functions by blocking the Factor XIa protein involved in blood clotting, marking the first regulatory approval for this drug class
Asundexian global prospects
- ▪Bayer pharmaceutical unit head Stefan Oelrich previously stated that Asundexian has blockbuster potential as a stroke treatment, after the drug previously failed as a therapy for a heart condition
- ▪Bayer has submitted Asundexian for regulatory review in additional jurisdictions including the United States and Europe
Bayer's business outlook and stock response
- ▪Bayer shares rose as much as 3.4% in early trading on October 26, 2026, bringing the stock's year-to-date gain to nearly 23%
- ▪Bayer is counting on Asundexian sales to counter revenue losses from generic competition following patent expirations on older blockbuster drugs Xarelto and Eylea
- ▪Bayer's broader pharmaceutical pipeline includes newer therapies such as the menopause treatment Lynkuet and the heart treatment Beyonttra
Stroke burden in China
- ▪Approximately one in ten of patients in China who survive a non-cardioembolic ischemic stroke experience a recurrent stroke within one year under existing prevention strategies
- ▪Stroke represents the primary cause of death and disability in China, which maintains the highest stroke prevalence globally
Competitors developing rival Factor XIa inhibitors
- ▪Novartis is developing an experimental blood thinner candidate named abelacimab to compete in the stroke prevention market
- ▪Bristol Myers Squibb and Johnson & Johnson are jointly conducting clinical testing on milvexian, an experimental competitor in the Factor XIa inhibitor drug class
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