India-based Zydus Cadila’s licensing agreement with China Medical System (CMS) Holdings Limited in January 2020 for the development and commercialisation of desidustat will provide a momentous boost to the overall commercialisation strategy for the anemia drug, says GlobalData, a leading data and analytics company.
Desidustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is indicated for the treatment of anemia in non-dialysis and dialysis-dependent chronic kidney disease (CKD) patients. CMS will be responsible for the development, registration and commercialisation of desidustat in China, while Zydus will receive an initial upfront payment, regulatory and sales milestones, and royalties on the net sales of the drug.
Bhavani Nelavelly, Pharma Analyst at GlobalData, said, “Desidustat is currently in Phase III clinical trials in India, and it is anticipated that the CMS-Zydus partnership will reduce development time, as CMS is well-financed and is trying to build up portfolio with the product-focussed investments, which would help to manage risk and investments associated with the product.
“China was the first country worldwide to approve a HIF-PHI, Ai Rui Zhuo (roxadustat), which was developed by AstraZeneca and FibroGen, and approved in December 2018. This adds to the consensus that China will increasingly play a much more significant global role in developing life science innovations.”
According to GlobalData’s Pharma Intelligence Centre, Ai Rui Zhuo is the only approved HIF-PHI in China and Japan. The other HIF-PHIs in late-stage development include vadadustat (Akebia), daprodustat (GSK), enarodustat (Japan Tobacco) and molidustat (Bayer; Japan only). However, none of these four drugs have any registered trials in China yet.