Zydus, a leading discovery based global pharmaceutical company recently announced that it has entered into a licensing agreement with China Medical System Holdings Limited (CMS) for the development and commercialization of Desidustat, a novel oral HIF-PH inhibitor for the treatment of anemia in patients with Chronic Kidney Disease (CKD) not-on-dialysis and for the treatment of Anemia CKD patients on dialysis in Greater China (Mainland China, Hong
Kong Special Administrative Region, Macao Special Administrative Region and Taiwan).

It has been reported that more than 120 million people are estimated to be living with CKD in China1 (Source: Zhang L, Wang F, Wang L et al. Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet 2012; 379: 815–822). CKD is a serious medical condition which is an unmet healthcare need involving gradual loss of functioning of kidneys eventually leading to kidney failure. If kidneys are healthy they will naturally secrete beneficial levels of a
hormone called erythropoietin (EPO), which encourages red blood cell production that carry oxygen to the muscles and brain. If the kidneys are impaired they will produce reduced levels or tire of EPO production completely, leading to fatigue and anemia.

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%, respectively2 . The target-achieving rate was only 8.2% for anemia patients in nondialysis CKD and 35.2% for dialysis CKD, showing unmet healthcare need3.

Speaking on the development, Pankaj R. Patel, Chairman, Zydus Group said, “The licensing agreement with CMS will facilitate the development and commercialization of Desidustat in Greater China, and make this innovative candidate available to millions of CKD patients living with anemia.” 

Under the license agreement, CMS will pay Zydus an initial upfront payment, regulatory milestones, sales milestones and royalties on net sales of the product. The commercial terms of the license agreement are confidential. CMS will be responsible for development, registration and commercialization of Desidustat in Greater China. 

Zydus had initiated two Phase III trials of Desidustat. The DREAM-ND (ClinicalTrials.gov Identifier: NCT04012957) Phase III trial is being conducted in CKD patients not-on-dialysis. The DREAM-D Phase III trial (ClinicalTrials.gov Identifier: NCT04215120) is being conducted in CKD patients on Dialysis. Desidustat had previously met its primary endpoints in the Phase II clinical studies and showed good safety profile. The Phase I trials were earlier
completed in Australia.