New Drug Application of Zydus’ Desidustat tablets by China Medical System Holdings accepted in China

Zydus Lifesciences 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, a wholly-owned subsidiary of China Medical System Holdings (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.

Discovered and developed by Zydus, Desidustat is being marketed by the group in India under the brand name Oxemia. China Medical System Holdings 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).

China Phase III trial of the Product has demonstrated positive results. The primary endpoint of the Hb mean change from baseline to the period of Week 7-9 has indicated that, Desidustat is more effective than placebo in increasing Hb level. The least squares mean and 95 per cent CI of Hb change from baseline to the period of Week 7-9, using covariance model analysis, has shown an increase of 16.38 g/l [95 per centCI: 14.50, 18.26] in the Desidustat group and a decrease of 1.13 g/l [95 per centCI: -3.68, 1.41] in the placebo group, for a between-group difference of 17.52 g/l [95 per centCI:14.353, 20.681], with the lower limit of 95 per cent CI above 0.

The product is administrated orally, thus expecting to improve the treatment compliance of patients and to meet the unmet treatment needs in the field of CKD anaemia, including both dialysis and non-dialysis patients.