Orforglipron

The global patient population of chronic kidney disease complicated with anemia is huge, which has long relied on erythropoietin drugs for treatment. However, such drugs have the risk of cardiovascular adverse events, so there is an urgent clinical need for safer alternative solutions. Vadadustat is a new type of oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), which can stabilize the expression of hypoxia-inducible factor by reversibly inhibiting the activity of prolyl hydroxylase, promote the production of endogenous erythropoietin, and improve iron absorption and utilization, so as to finally achieve the effect of correcting anemia. At present, this drug is mainly used to treat anemia related to chronic kidney disease, covering adult patients with non-dialysis-dependent and dialysis-dependent chronic kidney disease. Compared with traditional injectable drugs, the oral administration method greatly improves the medication compliance of patients.

As an emerging variety of HIF-PHI class, vadadustat has outstanding market growth potential. In 2024, the overall market size of HIF-PHI drugs already launched worldwide has exceeded US$3.2 billion, with a compound annual growth rate of more than 28%, among which local innovative varieties occupy a dominant share under the coverage of domestic medical insurance in China. Vadadustat is currently in the late clinical stage. With better stability of hemoglobin response and lower incidence of adverse reactions, it is expected to fill the clinical gap of existing products after its launch, and its peak annual sales in China are expected to exceed 1.5 billion yuan. At present, more than 10 domestic pharmaceutical companies have laid out the generic drug R&D of this variety, and the competition in the track is increasingly fierce.

Vadadustat was originally developed by Astellas Pharma of Japan, with the trade name Evrenzo. Its compound patent in China expires in 2033, and the core patent in Europe expires in 2034. The main dosage form approved by the original research is tablet, with specifications including 1mg, 2mg and 4mg, which has been included in the FDA Reference Listed Drug Catalog. Up to now, no vadadustat preparation has been approved for marketing in China, and there is no valid registration number of this variety 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 set of impurity reference standards for vadadustat API. Most of the products are 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, and fully meet the impurity research needs of pharmaceutical enterprises in the stages of R&D, registration and production of this variety.