CMS Gains Chinese Approval for New Anemia Drug Desidustat

Stock News03-13

CMS (00867) announced that the marketing authorization application for its new renal anemia drug, Desidustat Tablets, was approved by China's National Medical Products Administration (NMPA) on March 13, 2026. The product is an innovative oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), indicated for the treatment of anemia in adult chronic kidney disease (CKD) patients not on dialysis. CKD involves the progressive loss of kidney function, potentially leading to kidney failure. Healthy kidneys naturally secrete erythropoietin (EPO), a hormone that stimulates red blood cell production. Impaired kidney function can lead to reduced or absent EPO production, resulting in anemia. HIF-PHIs work by increasing the production of endogenous erythropoietin, improving iron utilization, and reducing hepcidin levels to promote erythropoiesis. The product achieved positive results in its Phase III clinical trials in China. Results for the primary endpoint, hemoglobin (Hb) levels (change from baseline in the average Hb level from weeks 7-9), showed the trial group was superior to the placebo group. Extension study results indicated the product can maintain Hb levels within the target range long-term with a good safety profile. Furthermore, the product significantly reduces hepcidin levels, helping to correct iron metabolism disorders.

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