China’s drug regulator has approved Bayer’s (BAYN) blood thinner asundexian, a potential boost for the German drugmaker in the world’s second-largest pharmaceutical market as it moves to counter competition from generic medicines.
Bayer is betting on asundexian to offset declining revenue from older blockbuster drugs such as its blood thinner Xarelto, which has faced increased competition from cheaper generics since losing patent protection.
China has the highest prevalence of stroke in the world, according to one study. Bayer said in May that the National Medical Products Administration had granted priority review designation for its marketing application, an accelerated approval pathway for drug candidates addressing urgent medical needs.
In one large, late-stage clinical trial involving 12,327 patients, 6.2 percent of those taking asundexian suffered another ischemic stroke, compared with 8.4 percent in the placebo group. Strokes that occurred in the asundexian group were also less likely to be moderate to severe.
Bayer did not immediately respond to a request for comment on when asundexian would become available in China, the cost to patients or sales estimates.
Other potential rivals include Novartis’ (NOVN) experimental abelacimab and a joint effort by Bristol Myers Squibb (BMY) and Johnson & Johnson (JNJ) to develop milvexian.