CMS(00867): The new drug De-Xi-Du-Si-Ta tablets for renal anemia has been approved for market in China.

CMS(00867) announced that the new drug for renal anemia, Dexidothitatin (formerly known as Deduthitatin) has obtained market approval from the China National Medical Products Administration (NMPA) on March 13, 2026. The product is an innovative oral hypoxia inducible factor-prolyl hydroxylase inhibitor (HIF-PHI), used for the treatment of anemia in adult non-dialysis chronic kidney disease (CKD) patients. In CKD patients, kidney function gradually deteriorates, eventually leading to kidney failure. Healthy kidneys naturally produce erythropoietin (EPO), a hormone that stimulates red blood cell production. If kidney function is compromised, the kidneys may produce less or no EPO, resulting in anemia. HIF-PHI promotes red blood cell production by increasing endogenous EPO production, improving iron utilization, and reducing hepcidin levels. The product's Phase III clinical trial in China yielded positive results. The main study endpoint of hemoglobin (Hb) levels (change in average Hb levels from baseline to weeks 7-9) showed superiority of the trial group over the placebo group. Extended study results demonstrated that the product can maintain Hb levels at target levels for a prolonged period and has good safety. Additionally, the product also significantly reduces hepcidin levels and corrects iron metabolism disorders.