Berotralstat

Renal anemia is one of the most common complications in patients with chronic kidney disease. Traditional erythropoietin-stimulating agents require intravenous administration and carry cardiovascular risks, and there has been a long-term unmet demand for safe medication in clinical practice. As a new generation of oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), vadadustat can stabilize hypoxia-inducible factor, promote the synthesis of endogenous erythropoietin, and improve iron metabolism disorders at the same time. It can effectively increase hemoglobin level without intravenous injection. At present, it is mainly used for the treatment of anemia associated with chronic kidney disease, and the applicable population covers adult chronic kidney disease patients both on dialysis and not on dialysis, providing a more convenient treatment option for the long-term management of renal anemia.

At present, the global market size of HIF-PHI drugs has exceeded 3 billion US dollars, with a compound annual growth rate of around 22% in the past three years, making it the fastest growing segment in the field of renal anemia. In the domestic market, vadadustat, as the second approved product in this category, is gradually seizing the market share of traditional drugs. At present, more than 10 domestic pharmaceutical companies have deployed generic drug R&D. With the expiration of core patents, market competition will further intensify in the future, and the corresponding demand for API and impurity reference standards will continue to rise. If verifiable public market data is not available, the actual industry statistics shall prevail.

The original developer of vadadustat is Japan Tobacco Inc., with the original brand name "Rocaba". The core compound patent will expire in China in 2033. The main dosage form approved for the original drug is tablet, with two specifications of 2mg and 4mg, which has been included in the Catalogue of Marketed Drugs in China as the reference listed drug. Up to now, no generic vadadustat preparation has been approved for marketing in China, and there is no registration information of domestic or imported vadadustat API in valid status on the CDE API registration platform. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full range of vadadustat impurity reference standards. Most products are regularly in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, fully meeting the reference substance use needs of pharmaceutical companies in the stages of generic drug R&D, quality research and production release.