FibroGen, a US-China novel drug company, and AstraZeneca announced China approval of their partnered drug for anemia, the first time an international novel drug was approved initially in China. Roxadustat is a first-in-class product approved for patients with chronic kidney disease who are on dialysis. Roxadustat was approved under Chinapriority rules that allow rolling submissions and promise a ruling six months after the submissions are complete. The approval marks a significant step toward meeting China’s goal of streamlining drug approvals for novel drugs.
Source: China Biotoday
