The approval has been granted by China’s drug regulator, the National Medical Products Administration (NMPA), for the treatment of renal anaemia in adult CKD patients who are not on dialysis. The drug has been licensed to a subsidiary of China Medical System Holdings, which will commercialise the therapy in the Chinese market. CMS International Development and Management Limited, a wholly owned subsidiary of China Medical System Holdings, had obtained an exclusive licence for the drug from Zydus in 2020.
In August 2025, the businessline had reported that Zydus had completed clinical trials for Desidustat in China and was preparing for a commercial launch with its local partner. Desidustat is an oral drug that helps the body produce more red blood cells and improve iron availability in patients whose kidneys are unable to produce enough erythropoietin — a hormone required for red blood cell production.
The therapy is a novel oral Hypoxia-Inducible Factor–Prolyl Hydroxylase Inhibitor (HIF-PHI) that promotes erythropoiesis by increasing endogenous erythropoietin levels, reducing hepcidin and improving iron availability. Because the drug is administered orally, it is also expected to improve treatment compliance among CKD patients.Anaemia is among the most common complications in CKD patients and tends to worsen as the disease progresses.
China presents a significant opportunity for the therapy. The country is estimated to have more than 120 million patients suffering from chronic kidney disease, with anaemia affecting a large share of them. Data cited by the company shows that anaemia prevalence in China rises sharply with disease progression—from about 22 per cent in CKD stage 1 to 98.2 per cent in stage 5.
While the haemoglobin target achievement rate has improved to about 51.5 per cent among haemodialysis CKD patients, it remains only around 8.2 per cent among non-dialysis patients, indicating a sizeable unmet medical need. Studies show that treatment targets for haemoglobin levels remain low among non-dialysis CKD patients, pointing to a sizeable unmet medical need.
The company also said Phase III clinical trials conducted in China met the primary efficacy endpoint. Extension study results demonstrated that the therapy could maintain haemoglobin levels within the target range over the long term with an acceptable safety profile while significantly reducing hepcidin levels and improving iron metabolism.
Commenting on the development, Sharvil Patel, managing director of Zydus Lifesciences, said the approval would help expand access to the company’s innovation-led therapies. “We are encouraged by the NMPA’s approval to for marketing the drug in China. Our life-changing discoveries are driven by a commitment to improving patient outcomes globally,” he said, adding that the company’s partnership with China Medical System will help reach patients across the Greater China region.
Desidustat was discovered and developed by Zydus and is already marketed in India under the brand Oxemia. The company said over 100,000 CKD patients in India have been treated with the drug since its launch in 2022.
Published on March 14, 2026