Shots:

• The NMPA’s approval is based on P-III study result assessing Roxadustat vs PBO in non-dialysis-dependent (NDD) patients with CKD demonstrating improvement in hemoglobin levels with a mean change of (1.9 g/dL vs -0.4 g/dL) on 7-9wks. treatment
• In 2013- AstraZeneca and FibroGen collaborated for the development & commercialization of Roxadustat in China. The NMPA’s approval follows the approval of Roxadustat for anemia in dialysis-dependent CKD patients in Dec’2018 in China
• Roxadustat is a hypoxia-inducible factor prolyl hydroxylase inhibitor- promoting erythropoiesis and is approved in China making it first country to approve Roxadustat for all CKD patients with anemia with its expected launch in China in H2’19

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Ref: AstraZeneca | Image: AstraZeneca