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.
Salubris will complete clinical trials according to
the relevant regulations and requirements of national drug registration
speedily, making the best effort to list this product in China, and providing
more efficient, safer and better new treatment options for patients with renal
anemia in China.
About renal anemia
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.
