
Zydus Lifesciences has received approval from China’s National Medical Products Administration (NMPA) for Desidustat, a treatment for anaemia in adult patients with chronic kidney disease (CKD) who are not undergoing dialysis.
The drug had earlier been licensed to China Medical System Holdings (CMS) for the Chinese market. The disclosure was made through a regulatory filing dated 14 March 2026.
CMS International Development and Management Limited, a wholly owned subsidiary of CMS, secured an exclusive licence from Zydus in 2020 to develop and commercialise the drug in China. Following the approval, the company can market the therapy for renal anaemia in the country.
The filing suggests that the approval follows Phase III clinical trials conducted in China. The study met its primary efficacy endpoint, demonstrating the drug’s ability to maintain haemoglobin levels within the required range over an extended treatment period.
Data from extension studies showed that the therapy maintained haemoglobin levels within the target range during long-term use. Researchers also reported reductions in hepcidin levels and improvements in iron metabolism among patients receiving the treatment.
Desidustat belongs to a class of medicines known as Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitors (HIF-PHI). The therapy works by stimulating the body’s natural production of erythropoietin, a hormone responsible for red blood cell formation.
In patients with chronic kidney disease, declining kidney function reduces erythropoietin production. This leads to lower red blood cell levels and the development of anaemia. HIF-PHI therapies help restore erythropoiesis while also improving iron availability in the body.
China has a large patient population affected by chronic kidney disease. Estimates cited in the company’s release indicate that more than 120 million people in the country are living with CKD.
Studies also show that anaemia becomes increasingly common as CKD progresses. Reported prevalence ranges from 22% in early-stage CKD to more than 98% in advanced stages of the disease.
The drug was discovered and developed by Zydus and is marketed in India under the brand name Oxemia. Since its introduction in 2022, the treatment has been used by over 100,000 CKD patients in India.
As of March 16, 2026, 11:18 am, Zydus Lifesciences share price was trading at ₹888.55, a 1.92% decrease from the previous closing price.
With regulatory clearance from China’s drug authority, Desidustat is now authorised for use in one of the world’s largest CKD patient markets. The approval enables CMS to introduce the therapy in China under its licensing arrangement with Zydus.
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Published on: Mar 16, 2026, 12:41 PM IST

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