Two three-stage clinical success of rosastah in China!

Related reading: first in Japan! On July 25, Tianbian Mitsubishi submitted the application for the listing of vadadustat, a new renal anemia drug AstraZeneca announced that roxadustat, its chronic renal anemia drug, had achieved positive results in two phase III clinical trials in China The results showed that the drug had better efficacy and safety The two trials, codenamed 806 and 808, evaluated the efficacy of losartan in the treatment of anemia caused by chronic kidney disease in Chinese patients with dialysis dependent (DD) or non dialysis dependent (NDD) chronic kidney disease The data of the two trials were published in the New England Journal of medicine The results showed that rosalta met the main goal of improving the effect of hemoglobin (HB) Compared with epoetin alfa treatment, the improvement time of patients treated with rosalta was 23 to 27 weeks longer than the average baseline value, which means that the efficacy of the drug is statistically significant In the analysis of inflammation patients with elevated C-reactive protein (CRP), rosholistat also achieved stable control of hemoglobin level in patients with inflammation, regardless of their inflammatory status, compared with epoetin alfa In addition, roxadustat's safety in both studies was consistent with previous clinical trials Currently, fibrogen is working with AstraZeneca to develop and commercialize losartan in the United States, China and other markets for the treatment of chronic renal anemia At the same time, fibrogen is working with Estelle to treat anemia in patients with chronic kidney disease and myelodysplastic syndrome in Europe, the Middle East and South Africa Roxadustat is the first hypoxia inducible factor prolyl hydroxylase (hif-ph) inhibitor It can not only increase the expression of erythropoietin, but also increase the expression of erythropoietin receptor and the protein promoting iron absorption and circulation "These trials suggest that hif-ph inhibitors may be more effective than current treatment standards in the treatment of chronic renal anaemia, especially in Chinese patients," said mene Pangalos, executive vice president of research and development at AstraZeneca There are about 120 million patients with chronic kidney disease in China, of which more than 400000 are receiving dialysis, and the rapid growth rate is double-digit, so the demand for anti anemia therapy is increasing Losartan will provide a new treatment for Chinese patients with chronic renal anemia In December 2018, rosastah took the lead in obtaining the approval of Chinese regulators worldwide for dialysis of anemia related to patients with dependent chronic kidney disease It is expected to be listed in China in the second half of this year Sales of the drug are expected to reach $1.97 billion in 2023 Currently, Rosas is also under Japanese regulatory review and plans to file an application in the United States in the third quarter However, rosastah's future development is not without worry, but also faces competition from other hif-ph inhibitors under development, including Akebia therapeutics, vadadustat at at Mitsubishi tagabe and daprodustat at at GlaxoSmithKline Daprodustat is expected to submit applications in Japan in 2019 and in the United States and Europe in 2020; Vadadustat is also expected to submit listing applications in the United States, the European Union and Japan within the year Reference source: az'roxadustat successful in late stage trial