BEIJING, Oct 26 (Reuters) – China’s drug regulator said on Monday it approved the blood thinner asundexian from Bayer, 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 had previously said in May that the National Medical Products Administration had granted priority review designation for its marketing application.
The pathway is an accelerated approval process for drug candidates addressing urgent medical needs.
For patients taking asundexian, 6.2% experienced another ischaemic stroke, compared with 8.4% in the placebo group, according to the results of one large, late-stage clinical trial.
Additionally, strokes that occurred in the asundexian group were less likely to be moderate to severe in the study involving 12,327 patients.
Bayer did not immediately respond to a request for comment on when asundexian would become available in China, the cost for patients or sales estimates.
Other potential Bayer rivals include Novartis’ experimental abelacimab and a joint effort by Bristol Myers Squibb and Johnson & Johnson to develop milvexian.
(Reporting by Andrew Silver; Editing by Kate Mayberry)
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