Zydus Lifesciences has received approval from China’s National Medical Products Administration (NMPA) for Desidustat tablets, indicated for the treatment of anaemia associated with chronic kidney disease (CKD).

Desidustat is an oral therapy discovered and developed by Zydus for the treatment of renal anaemia in patients suffering from chronic kidney disease. The therapy belongs to a class of drugs that help manage anaemia by stimulating the body’s natural production of red blood cells.

The drug has been licensed to CMS International Development and Management Ltd, a wholly owned subsidiary of China Medical System Holdings Ltd, under an exclusive licensing agreement signed between the two companies in 2020. Under the terms of the agreement, CMS is responsible for regulatory approvals, development activities, and commercialisation of the therapy in the Greater China region.

With the NMPA approval, CMS will now be able to introduce Desidustat in the Chinese market for the treatment of anaemia in CKD patients. The regulatory clearance marks a key step in the international expansion of the therapy beyond the Indian market.

Desidustat is already marketed in India under the brand name Oxemia for the treatment of anaemia in patients with chronic kidney disease. Since its launch in 2022, the therapy has been used in the treatment of more than 100,000 CKD patients in the country.

Chronic kidney disease often leads to reduced production of erythropoietin, a hormone responsible for the production of red blood cells, resulting in anaemia. Therapies such as Desidustat are used to manage this condition in CKD patients.

The approval from China’s NMPA allows Desidustat to enter one of the largest pharmaceutical markets globally through Zydus’ licensing partner, expanding the availability of the therapy for CKD-related anaemia treatment in the region.