Daprodustat

Renal anemia is one of the most common complications in patients with chronic kidney disease. Traditional erythropoietin-stimulating agents have limitations such as high cardiovascular risk and the need for intravenous administration. The launch of daprodustat provides a safer oral treatment option for such patients. As the world's first approved hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), it simulates the body's hypoxia response mechanism to stabilize the expression of HIF-α, while promoting the production of endogenous erythropoietin and improving iron absorption and utilization, eliminating the need for additional intravenous iron supplementation. It is currently approved for the treatment of renal anemia in adult chronic kidney disease patients on dialysis and not on dialysis, and there is no need to adjust the conventional dose based on patient age or mild to moderate hepatic and renal function impairment.

At present, the global market size of daprodustat has exceeded 1.7 billion US dollars, with a compound annual growth rate of more than 22% in the past 3 years. China is the fastest-growing regional market for this drug. On the one hand, this benefits from the clinical demand driven by nearly 120 million chronic kidney disease patients in China and the 60% prevalence rate of renal anemia among them. On the other hand, after the patent of daprodustat expired in 2023, domestic generic drugs were quickly approved for marketing. Up to now, more than 10 domestic pharmaceutical companies have had their generic drugs pass the consistency evaluation, and the drug has been included in the Category B of the National Medical Insurance Catalog, with its accessibility at the primary level continuously improving. It is expected that the domestic market size will still maintain an annual growth rate of more than 18% in the next 3 years.

CATO can provide a full set of impurity reference standards for daprodustat API. All products meet the quality requirements of both the Chinese Pharmacopoeia and FDA regulations, with complete structure confirmation and purity calibration data, and support associated review and declaration. The full series of products are sufficiently in stock, and can be delivered within 48 hours after placing an order. Meanwhile, customized synthesis services can be provided according to customers' R&D needs, covering the impurity reference standard requirements throughout the whole process from process development to registration and declaration.