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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Indian pharma major Zydus Lifesciences has received approval from China’s National Medical Products Administration (NMPA) for its novel drug Desidustat for the treatment of anaemia associated with Chronic Kidney Disease (CKD) in March 2026.
This marks the second regulatory approval for Desidustat, following approval by Drugs Controller General of India (DCGI) in March 2022 for the same indication. The clinical development programme for Desidustat, involving over 1,200 subjects, was one of the largest conducted in India for CKD-related anaemia.
Desidustat is marketed in India under the brand name Oxemia as a convenient oral tablet formulation (25 mg and 50 mg). Zydus has entered into a licensing agreement with China Medical System Holdings (CMS) for the development and commercialization of Desidustat in China.
Desidustat, a novel new chemical entity (NCE) and a Hypoxia-Inducible Factor Prolyl Hydroxylase (HIF-PH) inhibitor, is also under clinical evaluation for multiple indications, including:
Zydus has initiated Phase II clinical trials of Desidustat for the treatment of sickle cell disease in collaboration with the Indian Council of Medical Research (ICMR).
Additionally, the US Food and Drug Administration (USFDA) has granted Orphan Drug Designation (ODD) to Desidustat for the treatment of beta-thalassemia, with the potential for seven years of market exclusivity upon approval.
This approval represents a significant milestone for Indian pharmaceutical innovation and development of new drug molecules and novel therapies.
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