Zydus, a leading discovery based global pharmaceutical company based in India has 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).

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