New anemia drug gets China approval
Roxadustat, a domestically developed first-in-class Class 1 medicine, has received approval from the National Medical Products Administration, making China the first country that has greenlighted the oral medicine used for treatment of anemia caused by chronic kidney disease.
AstraZeneca China and Fibro-Gen China developed and incubated this first-in-class medicine and the drug was expected to be launched in China during the second half of 2019.
Industry sources said it marks a big leap for the Chinese pharmaceutical industry. "Roxadustat's approval in China demonstrates the determination of the Chinese government to accelerate the availability of urgently needed new clinical drugs to Chinese patients, and to support pharmaceutical innovation," said Leon Wang, executive vice-president international and president of AstraZeneca in China.