Zydus Lifesciences announced that its novel drug ‘Desidustat’ has received marketing approval from the National Medical Products Administration (NMPA) of China for treating renal anaemia in non-dialysis Chronic Kidney Disease (CKD) patients. The drug, licensed to China Medical System Holdings (CMS), is an oral HIF-PHI. This milestone marks a significant global expansion for Zydus’ discovery and addresses an unmet medical need for over 120 million CKD patients in China.
Zydus Drug Approval in China Secured
Zydus Lifesciences Limited announced on March 14, 2026, that its innovative drug discovery, ‘Desidustat’, has been approved by the National Medical Products Administration (NMPA) of China for the treatment of renal anaemia. The drug was licensed to China Medical System Holdings Limited (“CMS”) through its subsidiary in 2020, which will now market the product.
Desidustat: Mechanism and Market Potential
Desidustat tablets are a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI). It is designed to treat anaemia in non-dialysis adult CKD patients by promoting erythropoiesis through increasing endogenous erythropoietin and improving iron availability. The treatment is administered orally, which is expected to improve patient compliance.
This approval addresses a substantial unmet need, as it is estimated that there are more than 120 million CKD patients in China. The Phase III clinical trial demonstrated positive results, meeting the primary efficacy endpoint and showing the drug could maintain $\text{Hb}$ levels with acceptable safety while significantly reducing hepcidin levels.
Statement from Zydus Leadership
Speaking on the development, Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, stated, “We are encouraged by the NMPA’s approval for marketing the drug in China. Our life-changing discoveries are driven by a commitment to improving patient outcomes and enabling healthier, more fulfilled lives, globally.”
Zydus already markets the drug in India under the brand name Oxemia™ since its launch in 2022, where it has treated more than 1 lac CKD patients.
About China Medical System Holdings (CMS)
CMS is described as a platform company focused on linking pharmaceutical innovation and commercialization. It concentrates on global first-in-class (FIC) and best-in-class (BIC) innovative products. CMS has deep engagement in specialty therapeutic fields, including the Cardiovascular-Kidney-Metabolic area, which is highly relevant to the Desidustat approval.
Source: BSE
