On January 12, the first subject has been dosed in China Phase III bridging trial of Desidustat Tablets, the innovative medicine of China Medical System Holdings Limited. This is another major progress in China following the localized manufacturing of preparations used for clinical trials through technology transfer, the approval of clinical trials as Category 1 New Drug, and the completion of the Phase I pharmacokinetic study.
The trial is a randomized, double-blind, placebo controlled, multi-center Phase III bridging trial, aiming to evaluate the efficacy of Desidustat Tablets in the treatment of anemia caused by non-dialysis chronic kidney disease (CKD) based on changes in hemoglobin (Hb) level from baseline. With Peking Union Medical College Hospital, Chinese Academy of Medical Sciences being the leading hospital, the study is planned to enroll 150 subjects and will be conducted in around 20 sites nationwide. Prof. Xuemei Li, the vice chairman of Chinese Society of Nephrology and vice president of China Nephrology Alliance, served as the principal investigator of the leading hospital and will lead domestic leading Nephrology experts to carry out this study.
Desidustat Tablets is a novel oral Hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI), which promotes erythropoiesis through increasing endogenous erythropoietin, improving iron availability, and reducing hepcidin, so as to treat anemia caused by CKD. Overseas, two Phase III clinical trials of the product have obtained positive data, based on which Zydus, the Group’s collaborative partner, has submitted the New Drug Application to the Drug Controller General of India (DCGI) in November 2021.
It is estimated that more than 120 million patients are living with CKD in China, and anemia is one of the frequent complications of CKD. A survey in China showed that the prevalence of anemia in patients at CKD stage 1 to 5 were 22.0%, 37.0%, 45.4%, 85.1%, and 98.2%, respectively. However, the target-achieving rate (Hb level reaching the target value 110~120g/L) was only 8.2% for anemia patients in non-dialysis CKD and 35.2% for hemodialysis CKD. As a novel oral HIF-PHI, Desidustat Tablets, with good compliance, is expected to meet this unmet treatment need.