Roxadustat

Renal anemia is one of the most common complications in patients with chronic kidney disease. For a long time, it has relied on exogenous erythropoietin for treatment, which has clinical pain points such as high cardiovascular risk and limited iron utilization. Roxadustat, as the world's first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), stabilizes HIF-α by simulating a hypoxic state, while promoting the production of endogenous erythropoietin and improving iron absorption and utilization, breaking the limitations of traditional treatment. Its indications cover dialysis-dependent and non-dialysis-dependent chronic kidney disease-related anemia, providing a more convenient and safe oral treatment option for patients with renal anemia at different stages of the disease course.

The domestic market size of roxadustat had exceeded 1.5 billion yuan in 2022, with an average annual compound growth rate of more than 35% in the past three years. As the prevalence of chronic kidney disease rises to 10.8% and the reimbursement scope for special outpatient diseases expands, the market still has considerable growth potential. In terms of the competitive landscape, among the preparations currently approved for marketing in China, in addition to the original research drug, 3 generic drug manufacturers have passed the consistency evaluation. In the inter-provincial alliance centralized procurement in 2023, the average price reduction of this variety reached 73%, the generic drug substitution process has accelerated significantly, and the demand for upstream API has continued to increase accordingly.

The original research enterprise of roxadustat is FibroGen, and the original trade name is "Evrenzo". The expiration date of its core compound patent in China is 2033, and the expiration date of the indication patent is 2024. The approved original dosage form is tablets, with specifications including 20mg, 50mg and 100mg, which are included in the *Catalogue of Chemical Reference Preparations (39th Batch)* of China and the FDA reference preparation catalogue. In terms of domestic API registration, as of now, 6 enterprises have obtained CDE registration numbers for their APIs, among which 3 registration statuses are A (approved for use in marketed preparations), and 9 roxadustat generic preparations have been approved for marketing in China. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for roxadustat. Most products are available from stock, and stock orders placed before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and fully meet the compliance needs of different scenarios such as API R&D, quality research and consistency evaluation.