China Medical System Holdings (CMS; HKG: 0867) has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its desidustat. The oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) is under development to treat anemia in adult chronic kidney disease (CKD) patients who are not on dialysis.
CKD patients often experience a gradual loss of renal function, which leads to a decrease in the secretion of erythropoietin (EPO) and results in anemia. HIF-PHI drugs like desidustat can stimulate erythropoiesis by increasing the production of endogenous erythropoietin, improving iron utilization, and reducing iron regulatory levels. CMS entered into an in-licensing agreement with Indian pharmaceutical company Zydus Lifesciences Limited in January 2020 to acquire the rights to the drug.
A Phase III clinical study demonstrated that desidustat significantly improved hemoglobin (Hb) levels compared to placebo, with the average hemoglobin levels at weeks 7-9 changing from baseline by 16.38g/L in the desidustat group and -1.13g/L in the placebo group, successfully meeting the primary endpoint of the study.- Flcube.com
