Zydus’ new drug application of Desidustat tablets accepted by China Medical System Holdings
Drug Approval

Zydus’ new drug application of Desidustat tablets accepted by China Medical System Holdings

Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients

  • By IPP Bureau | April 23, 2024

Zydus Lifesciences Limited, a discovery-driven, global lifesciences company, announced that the New Drug Application (NDA) of Desidustat Tablets has been accepted by the National Medical Products Administration of China (NMPA).

CMS International Development and Management Limited, a wholly-owned subsidiary of China Medical System Holdings Limited (CMS) obtained an exclusive license for the Product from Zydus in 2020.

Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients.

CKD involves the gradual loss of functioning of kidneys and eventually leads to kidney failure. Healthy kidneys naturally secrete a hormone called Erythropoietin (EPO), which stimulates red blood cell production also known as erythropoiesis.

When kidneys are impaired as in patients suffering from Chronic Kidney Disease, EPO production is impaired, leading to development of anaemia. HIF-PHI promotes erythropoiesis through increasing endogenous erythropoietin, reducing hepcidin thereby improves iron availability.

Speaking on the development, Managing Director of Zydus Lifesciences, Dr. Sharvil Patel said, "We are excited about the NDA acceptance of Desidustat in China by NMPA. Our life-changing discoveries are guided by the need to help patients and empower them with therapies that enable them to live healthier and more fulfilled lives. We believe this collaboration with CMS will accelerate the development and commercialization process of Desidustat in Greater China".

Discovered and developed by Zydus, Desidustat is being marketed by the group in India under the brand name Oxemia. China Medical System Holdings Limited through its wholly-owned subsidiary gained a royalty bearing, exclusive, sub-licensable license under the licensed technology and Zydus data to develop, register and to manufacture, use and commercialise the Product in Greater China (including Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan).

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