Zydus Lifesciences has secured approval from China’s National Medical Products Administration (NMPA) for its drug Desidustat tablets. The approval allows the treatment to be marketed for renal anaemia in patients suffering from chronic kidney disease (CKD). This development marks an important regulatory milestone for the company as it expands its presence in the Chinese pharmaceutical market.
Licensing Agreement with CMS Holdings
Zydus had earlier entered into an exclusive licensing agreement with CMS International Development and Management Limited, a wholly owned subsidiary of China Medical System Holdings. Under this agreement signed in 2020, CMS obtained the rights to develop, register, manufacture and commercialise Desidustat across Greater China, including mainland China, Hong Kong, Macau and Taiwan.
As per The Times of India, this collaboration has played a key role in advancing the regulatory and commercial pathway for the drug in China.
About Desidustat
Desidustat is an oral hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI). The drug helps treat anaemia in patients with chronic kidney disease by stimulating the production of erythropoietin and improving iron availability in the body. Anaemia is a common complication among CKD patients because impaired kidneys cannot produce enough of the hormone needed to generate red blood cells.
Use of the Drug in India
Zydus already markets Desidustat in India under the brand name Oxemia. Since its launch in 2022, the therapy has been used to treat more than 100,000 CKD patients in the country. The successful use of the drug in India has strengthened confidence in its effectiveness and safety profile.
Company Outlook
Zydus leadership has expressed optimism about the approval, noting that the Chinese market represents a significant opportunity for innovative therapies targeting chronic kidney disease. With regulatory clearance now in place, the collaboration with CMS is expected to accelerate the availability of Desidustat to patients across China.