FibroGen, a US-China biopharma, reported the CFDA has accepted an NDA to review its novel anemia treatment for China approval. Roxadustat is a first-in-class oral treatment for anemia in patients undergoing kidney dialysis. The China review is the first filing for the candidate. In 2013, FibroGen formed a 50/50 joint venture with AstraZeneca, which signed a $357 million deal to co-develop roxadustat in China. The China acceptance of the NDA triggers a $15 million payment to FibroGen.
Source: China Biotoday
