Zydus Licenses Desidustat to CMS, Gains NMPA Approval in China
Filing Summary
Zydus Lifesciences Ltd has announced that its drug, Desidustat, has received approval from the National Medical Products Administration (NMPA) of China for treating renal anaemia. The drug, licensed to China Medical System Holdings (CMS), is a novel oral HIF-PHI for anaemia in non-dialysis CKD patients. CMS obtained an exclusive license from Zydus in 2020. The approval follows successful Phase III trials in China. Desidustat is marketed in India as Oxemia™. This development addresses the significant unmet need for CKD anaemia treatment in China, where over 120 million CKD patients are estimated.
Zydus Lifesciences Ltd has announced the approval of its drug, Desidustat, by the National Medical Products Administration (NMPA) of China. The drug, which is licensed to China Medical System Holdings (CMS), is designed to treat renal anaemia in non-dialysis adult patients with Chronic Kidney Disease (CKD). Desidustat is an oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) and is administered orally. CMS obtained an exclusive license for Desidustat from Zydus in 2020.
The financial terms of the licensing agreement between Zydus and CMS have not been disclosed in the filing. The agreement grants CMS the rights to market and distribute Desidustat in China. The drug’s approval by the NMPA follows successful Phase III clinical trials conducted in China, which demonstrated positive results in maintaining haemoglobin levels within the target range and improving iron metabolism disorders.
The scope of the agreement includes the commercialization of Desidustat in China, addressing the unmet treatment needs for CKD anaemia. The drug’s oral administration is expected to improve patient compliance. Desidustat works by increasing endogenous erythropoietin and reducing hepcidin levels, thereby enhancing iron availability and promoting erythropoiesis. This mechanism is particularly beneficial for CKD patients, whose impaired kidneys reduce natural erythropoietin production, leading to anaemia.
In the context of the Chinese market, there is a significant unmet need for effective CKD anaemia treatments. It is estimated that over 120 million people in China suffer from CKD, with anaemia being a common complication. The prevalence of anaemia increases with the progression of CKD, highlighting the importance of effective treatment options like Desidustat.
The timeline for the implementation of the agreement began with the licensing of Desidustat to CMS in 2020. The recent approval by the NMPA marks a significant milestone in the drug’s commercialization in China. The successful Phase III trials and subsequent approval are key steps in bringing Desidustat to the Chinese market.
China Medical System Holdings focuses on pharmaceutical innovation and commercialization, with a strong emphasis on first-in-class and best-in-class products. CMS has developed extensive networks and commercialization capabilities, particularly in specialty therapeutic fields, which will support the distribution and marketing of Desidustat in China.
Zydus Lifesciences Ltd is a global lifesciences company that discovers, develops, and markets a broad range of healthcare therapies. The company is committed to innovation and improving patient outcomes through its diverse portfolio of products. Zydus continues to focus on addressing unmet healthcare needs with its innovative therapies and strategic partnerships.