Zydus Lifesciences Ltd on Tuesday said its new drug application of Desidustat tablets, indicated for treating anemia in chronic kidney disease patients, has been accepted by the National Medical Products Administration of China.
Discovered and developed by Zydus, Desidustat is being marketed by the group in India under the brand name Oxemia. 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 in 2020, Zydus Lifesciences said in a regulatory filing.
CMS had filed a New Drug Application (NDA) for the drug in China.
"China Phase III trial of the product has demonstrated positive results. The primary endpoint has indicated that Desidustat is more effective than the Placebo in increasing Hb (hemoglobin) level," the company said.
Commenting on the NDA acceptance of Desidustat in China by National Medical Products Administration (NMPA), Zydus Lifesciences Managing Director, Sharvil Patel said, "We believe this collaboration with CMS will accelerate the development and commercialisation process of Desidustat in Greater China."
CMS holds the license to develop, register, manufacture, use and commercialise the Desidustat in Greater China, including mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan, the company said.
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