FibroGen, Inc. Announces Chinese State FDA Approval of Phase 1 and 2 Development of FibroGen Oral Anemia Therapy, FG-4592

SAN FRANCISCO--(BUSINESS WIRE)--FibroGen, Inc., today announced that its investigational oral anemia therapy, FG-4592, received Clinical Trial Application (CTA) approval from the Chinese State Food and Drug Administration (SFDA) to commence clinical development for the treatment of anemia associated with chronic kidney disease (CKD) in the People’s Republic of China. FG-4592 is a first-in-class hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (PHI) entering Phase 2b clinical development in the US and Europe for the treatment of CKD anemia. SFDA approved protocols for both Phase 1 and 2 studies. The first of these studies of FG-4592 in China will begin in the fourth quarter of 2010.

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