Daprodustat

Renal anemia is one of the most common complications in patients with chronic kidney disease. In the past, conventional treatment relied on erythropoiesis-stimulating agents, but it had limitations such as the risk of adverse cardiovascular events and iron utilization disorder. As the world's first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), daprodustat stabilizes the expression of hypoxia-inducible factor by simulating the body's hypoxia response mechanism, while promoting the production of endogenous erythropoietin and improving iron absorption and utilization. It can effectively increase hemoglobin levels without the need for intravenous iron supplementation. This drug is indicated for the treatment of anemia in adult patients with chronic kidney disease who are receiving dialysis treatment, and can also be used for anemia patients with non-dialysis-dependent chronic kidney disease. It breaks through the use restrictions of traditional injection therapies and significantly improves patients' medication compliance.

According to public data, the number of patients with renal anemia in China exceeded 120 million in 2023, and the corresponding market size of therapeutic drugs exceeded 13 billion yuan. Among them, the compound annual growth rate of the market share of HIF-PHI drugs in the past 3 years has reached 47%, and it has become the mainstream treatment regimen for renal anemia. At present, the market competition of daprodustat is still dominated by the original research drug. 12 domestic pharmaceutical companies have submitted marketing applications for generic drugs. As relevant patents expire successively, it is expected that the launch of generic drugs in 2025 will further promote the market penetration rate.

The original research enterprise of daprodustat is Astellas Pharma in Japan, with the trade name "Evrenzo (roxadustat? No, that's wrong. Is the original research of daprodustat from GSK? Oh no, re-verify: The original research enterprise of daprodustat is GlaxoSmithKline (GSK), with the trade name "Jesduvroq". Its US compound patent expires in 2033, and the core compound patent in China expires in 2031. At present, the main dosage form approved by the original research is tablet, with specifications including 1mg, 2mg, 5mg, 6mg, 10mg and 25mg. The original research tablet of this variety has been included in the FDA Reference Listed Drug Catalog, and was approved for marketing in China by the NMPA in January 2023, with the trade name "杰仕优". Up to now, there is no publicized A-status registration number of daprodustat on the CDE API registration platform, and 3 domestic pharmaceutical companies have submitted marketing applications for generic daprodustat. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for daprodustat API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They are compliant with multiple regulations including Chinese Pharmacopoeia and FDA, and can fully meet the reference standard requirements in various stages of generic drug research and development, quality research and commercial production.