AstraZeneca gets China approval for roxadustat
AstraZeneca's roxadustat drug has been approved in China for the treatment of anaemia in chronic kidney disease patients on dialysis.
AstraZeneca
12,370.00p
16:40 10/05/24
FTSE 100
8,433.76
16:34 10/05/24
FTSE 350
4,634.75
17:09 10/05/24
FTSE All-Share
4,586.29
16:50 10/05/24
Pharmaceuticals & Biotechnology
23,725.34
17:09 10/05/24
The pharmaceuticals giant said on Tuesday that its partner, FibroGen China, has received formal marketing authorisation from the National Medical Products Administration and the medicine can be prescribed to patients who use haemodialysis or peritoneal dialysis.
Sean Bohen, executive vice president of Global Medicines Development and chief medical officer at Astra, said: "Roxadustat is a long-awaited, first-in-class medicine for patients with anaemia in chronic kidney disease that are on dialysis. This first approval of roxadustat in China is a significant step towards achieving our ambition to transform care in a condition where prevalence in China is increasing."
AstraZeneca and FibroGen China are collaborating on the development and commercialisation of roxadustat in China. Beijing-based FibroGen China conducted the Phase III clinical trials and submitted the new drug application for registration of roxadustat to the Chinese regulatory authorities.
Following this approval, AstraZeneca will manage commercialisation activities in China, while FibroGen China will manage commercial manufacturing and medical affairs as well as continued clinical development and regulatory affairs. They expect to launch roxadustat in China in the second half of next year.
At 1112 GMT, the shares were down 0.6% to 6,009p.