China’s NMPA approves Zydus Lifesciences’ Desidustat, an oral HIF-PH inhibitor, for the treatment of renal anaemia in chronic kidney disease patients, expanding access in China.
Written By: Pharmacally Medical News Desk
Zydus Lifesciences Limited announced that China’s National Medical Products Administration (NMPA) has approved its innovative drug Desidustat tablets for the treatment of renal anaemia in patients with chronic kidney disease (CKD). The drug has been licensed to CMS International Development and Management Limited, a wholly owned subsidiary of China Medical System Holdings Limited, which secured exclusive commercialization rights from Zydus in 2020.
Desidustat is an oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI) designed to treat anaemia associated with CKD. The therapy works by stimulating endogenous erythropoietin production, reducing hepcidin levels, and improving iron availability, thereby promoting red blood cell production. In patients with CKD, impaired kidney function reduces erythropoietin secretion, leading to decreased erythropoiesis and the development of anaemia.
The approval was supported by Phase III clinical trial data in Chinese patients with non-dialysis chronic kidney disease, along with global pivotal studies including the DREAM-ND (NCT04012957) and DREAM-D (NCT04215120) trials that evaluated the efficacy and safety of Desidustat in CKD-related anaemia.
Commenting on the approval, Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences, said the company is encouraged by the NMPA’s decision and believes the partnership with CMS will help expand access to the therapy for patients across Greater China. He noted that the company’s research efforts focus on developing life-changing therapies that improve patient outcomes worldwide.
Desidustat was discovered and developed by Zydus and is already marketed in India under the brand name Oxemia™, where it has been used to treat more than 100,000 CKD patients since its launch in 2022.
China represents a significant unmet need for CKD-related anaemia treatment. More than 120 million people in China are estimated to be living with CKD, and anaemia is a common complication that becomes more prevalent as the disease progresses.
Surveys indicate anaemia prevalence rates of 22% in stage 1 CKD, rising to over 98% in stage 5 disease. While haemoglobin target achievement rates among haemodialysis patients have improved to about 51.5%, only around 8.2% of non-dialysis CKD patients achieve recommended haemoglobin targets.
As an oral therapy, Desidustat may improve treatment adherence and provide a convenient option for managing CKD-related anaemia, addressing an important gap in current treatment options for patients in China.
References
Zydus’ new drug discovery, ‘Desidustat’ licensed to China Medical System Holdings receives approval from NMPA of China, Zydus,
Desidustat in the Treatment of Anemia in CKD (DREAM-ND), ClinicalTrials.gov ID NCT04012957, https://clinicaltrials.gov/study/NCT04012957
Desidustat in the Treatment of Anemia in CKD on Dialysis Patients (DREAM-D), ClinicalTrials.gov ID NCT04215120, https://clinicaltrials.gov/study/NCT04215120