Enarodustat

The clinical treatment of chronic kidney disease (CKD)-related renal anemia has long relied on erythropoiesis-stimulating agents (ESA), but such drugs have limitations such as increased risk of cardiovascular events and the need for frequent intravenous iron supplementation. As the world's first marketed hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), enarodustat stabilizes the level of hypoxia-inducible factor in the body, simulates a physiological hypoxic state, promotes the production of endogenous erythropoietin, and improves iron metabolism disorders at the same time. It can effectively increase hemoglobin levels without additional intravenous iron supplementation. At present, the approved indication of this drug is the treatment of anemia in patients with chronic kidney disease, covering both dialysis-dependent and non-dialysis-dependent populations, providing a safer oral treatment option for patients with renal anemia.

The huge base of renal anemia patients worldwide drives the continuous expansion of the HIF-PHI drug market. In 2023, the global market size related to enarodustat has exceeded 1.2 billion US dollars, with a compound annual growth rate maintained at more than 21%. At present, the market supply of this variety is still dominated by the original research drug, and more than ten domestic pharmaceutical companies have laid out the research and development of generic drugs. With the expiration of core patents, it is expected that generic drugs will gradually enter the centralized procurement system after 2027, and the market price is expected to drop by more than 40%. At present, the domestic API filing is still in the early stage, and there are fewer than 5 manufacturers with compliant registration qualifications, so the supply gap of upstream API is relatively obvious.

The original research enterprise of enarodustat is Japan Tobacco Inc., and the original brand name is "Evadomed". Its core compound patent expires in China in November 2025, and the core patent in the United States expires in July 2026. The main dosage form approved by the original research is tablet, with specifications of 1mg, 2mg and 4mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs (63rd Batch)* issued by China NMPA, and also listed in the FDA reference preparation catalogue. Up to now, 3 Chinese enterprises have obtained Class A status for their enarodustat APIs through CDE registration, and the original research drug and generic preparations from 2 pharmaceutical companies have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for enarodustat, and most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and fully meet the compliance needs of API research and development, quality research, and registration declaration at all stages.