In August 2020, Salubris received the Notice of Approval of Clinical Trials from National Medical Products Administration, and initiated human clinical trials.

The active ingredient of Enarodustat Tablets is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), which is a noval chemical to treat  renal anemia. Enarodustat is protected an independent intellectual property rights in major countries/regions around the world. Phase I/III clinical trials are being carried out, and is expected to be approved for marketing in China in 2022.

The "oxygen sensing mechanism" which Enarodustat is based on won the Nobel Prize in Physiology or Medicine in 2019. The mechanism of treating anemia by Enarodustat is clear, which can promote the production of endogenous erythropoietin, and improve transport of iron.

Renal anemia is an anemia caused by the decrease of erythropoietin (EPO) production in kidney ; and interference of toxic substances in plasma with erythropoiesis that  shortens red cell  life span.

Chronic kidney disease (CKD) has become an important public health challenge in China. The prevalence rate of CKD in China accounts for about 10.8% (120 million people) of adults, and more than 50% of them are complicated with anemia. [1] About half of the new dialysis patients were not treated for anemia before dialysis, and the other half of the patients who had received treatment also has the problems of low compliance and poor compliance.

At present, the combination therapy of ESAs + iron is an effective therapeutic regimen to treat renal anemia. Enarodustat Tablets is expected to solve many problems associated with injections, and improve iron utilization in vivo on the basis of inducing endogenous EPO through biological response against hypoxia.

References:

[1]Zhang L, Wang F, Wang L, et al. Prevalence of chronic kidney disease in China: a cross⁃sectional survey[J]. Lancet, 2012, 379 (9818): 815~822.