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FibroGen/AstraZeneca Novel Anemia Drug Approved in China -- Before US/EU Approvals

publication date: Dec 27, 2018

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 China priority 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. More details....

Stock Symbols: (NSDQ: FGEN) (NYSE: AZN)

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