China Approves Bayer's Blood Thinner Asundexian

China's National Medical Products Administration has approved Bayer's blood thinner asundexian, giving the German drugmaker a foothold in the world's second-largest pharmaceutical market. Bayer is counting on asundexian to make up for declining sales of older blockbuster drugs, including its blood thinner Xarelto, which has faced growing pressure from cheaper generics after losing patent protection.

China is an especially significant market for the drug: one study identifies the country as having the highest prevalence of stroke in the world. Bayer had announced in May that the regulator had granted priority review designation for its marketing application, an accelerated pathway reserved for drug candidates addressing urgent medical needs.

Results from one large, late-stage clinical trial involving 12,327 patients showed that 6.2% of those taking asundexian experienced another ischaemic stroke, compared with 8.4% in the placebo group. Strokes that did occur among asundexian patients were also less likely to be moderate to severe.

Bayer has not said when the drug will become available in China, what it will cost patients, or what sales it expects. Competitors in the space include Novartis, which is developing experimental abelacimab, and a joint effort by Bristol Myers Squibb and Johnson & Johnson on milvexian.