Zydus Drug Gets China Nod for CKD Anemia

Zydus Lifesciences has secured marketing approval in China for its drug Desidustat, a significant development for treating renal anemia in adult CKD patients not on dialysis. The approval was granted by China's National Medical Products Administration (NMPA), opening a substantial new market for the pharmaceutical company.

Desidustat, licensed to a subsidiary of China Medical System Holdings, will be commercialized in China. This oral therapy is a Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) designed to promote erythropoiesis by increasing endogenous erythropoietin levels and improving iron availability. This approach is expected to enhance treatment compliance among CKD patients.

China presents a significant opportunity, with an estimated 120 million CKD patients, many of whom suffer from anemia. The prevalence of anemia rises sharply with CKD progression, highlighting a large unmet medical need, particularly among non-dialysis patients where treatment targets remain low.

Phase III clinical trials conducted in China met their primary efficacy endpoint, demonstrating Desidustat's ability to maintain hemoglobin levels within the target range with an acceptable safety profile. The drug is already marketed in India as Oxemia, where it has treated over 100,000 CKD patients since its 2022 launch.