New anemia drug gets China approval
ZHENG YIRAN Roxadustat, a domestically developed Class 1 medicine, received marketing approval from the National Medical Products Administration on Tuesday, a milestone for China’s biopharmaceutical research and development industry.
AstraZeneca China and FibroGen China developed and incubated this first-of-its-kind oral medicine for anemia.
“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 China president at AstraZeneca.
Roxadustat is designed to treat anemia caused by chronic kidney disease in patients who are dialysis-dependent. AstraZeneca and FibroGen announced they expect to launch the product in China in the second half of 2019.
“In the future, AstraZeneca will work closely with the government to increase the accessibility of roxadustat in China, and to use the drug to benefit more Chinese patients. At the same time, in response to the Chinese government’s call for pharmaceutical innovation, we will build a local incubation platform to make more new drugs that benefit
China first, and open up China’s pharmaceutical innovations to the world,” Leon said.
Chen Nan, lead principal investigator in the Phase-III clinical trial of roxadustat in China and professor of Shanghai Jiao Tong University School of Medicine, said: “Thanks to the improvement of China’s pharmaceutical innovation atmosphere, domestic investigators now have much better opportunities to show their excellence, alongside their international peers, in the global clinical development of first-in-class innovative drugs.”