Zydus’ Desidustat Gets China Approval for CKD Anaemia Treatment

Zydus Lifesciences has received marketing approval in China for its drug Desidustat, used to treat anaemia in patients suffering from Chronic Kidney Disease (CKD). The approval was granted by China’s drug regulator, the National Medical Products Administration (NMPA), marking a significant step for the Ahmedabad-based pharmaceutical company as it enters one of the world’s largest healthcare markets.

Approval for non-dialysis CKD patients

The NMPA has approved Desidustat for the treatment of renal anaemia in adult CKD patients who are not on dialysis. The drug will be commercialised in China through CMS International Development and Management Limited, a wholly owned subsidiary of China Medical System Holdings.

Zydus had granted an exclusive licence for the therapy to the Chinese company in 2020. Following successful clinical trials and regulatory evaluation, the approval now enables the partners to launch the drug in the Chinese market.

How the drug works

Desidustat is a novel oral therapy that stimulates the body’s ability to produce red blood cells. It works by increasing endogenous erythropoietin levels, lowering hepcidin and improving iron availability in the body.

The medicine belongs to a class of drugs known as Hypoxia-Inducible Factor–Prolyl Hydroxylase Inhibitors (HIF-PHI). Because it is administered orally rather than through injections, it can improve treatment convenience and patient compliance among people suffering from chronic kidney disease.

Large unmet medical need in China

China represents a major opportunity for the therapy due to the high prevalence of chronic kidney disease. The country is estimated to have more than 120 million CKD patients, with anaemia affecting a large proportion of them.

The prevalence of anaemia rises significantly as the disease progresses—from about 22 per cent in early stages of CKD to over 98 per cent in advanced stages. While haemoglobin targets are achieved in about half of haemodialysis patients, the rate remains very low among non-dialysis patients, indicating a major unmet medical need.

Important Facts for Exams

• Desidustat is an oral drug used to treat anaemia in Chronic Kidney Disease (CKD) patients.
• It belongs to the class of Hypoxia-Inducible Factor–Prolyl Hydroxylase Inhibitors (HIF-PHI).
• The drug was developed by Zydus Lifesciences and marketed in India under the brand name Oxemia.
• China’s drug regulator is the National Medical Products Administration (NMPA).

Development and global expansion

Desidustat was discovered and developed by Zydus Lifesciences and has been marketed in India since 2022 under the brand Oxemia. The company reports that more than 100,000 CKD patients in India have already received the therapy.

Phase III clinical trials conducted in China met the primary efficacy endpoints, demonstrating that the drug can maintain haemoglobin levels within the target range over the long term while maintaining an acceptable safety profile. The approval is expected to expand global access to the therapy and strengthen Zydus’ innovation-driven pharmaceutical portfolio.