Ahmedabad-based Zydus Lifesciences said on Tuesday that a new drug application for its oral drug Desidustat used in treating anaemia in chronic kidney disease (CKD) patients had been accepted by the National Medical Products Administration of China (NMPA).
In 2020, CMS International Development and Management Ltd, a wholly-owned subsidiary of China Medical System Holdings Ltd obtained an exclusive license for the product from Zydus.
CKD involves a 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 among patients suffering from chronic kidney disease, EPO production is impaired, leading to the development of anaemia.
Sharvil Patel, MD, Zydus Lifesciences said, “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 commercialisation 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 through its wholly-owned subsidiary gained a royalty-bearing, exclusive, sub-licensable license under the licensed technology and Zydus data to develop, register and manufacture, use and commercialise the product in Greater China (including Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan).
It is estimated that more than 120 million people are living with CKD in China.
Anaemia is one of the frequent complications of CKD.
A survey in China showed that the prevalence of anaemia in patients at CKD stage 1 to 5 was 22 per cent, 37 per cent, 45.4 per cent, 85.1 per cent, and 98.2 per cent, respectively.
“China Phase-III trial of the product has demonstrated positive results.
"The primary endpoint of the haemoglobin mean change from baseline to the period of week 7-9 has indicated that Desidustat is more effective than placebo in increasing haemoglobin level,” Zydus claimed.
