Atrasentan

There has long been a lack of targeted intervention targets for the disease progression risk of patients with chronic kidney disease complicated with type 2 diabetes mellitus, and renal hemodynamic disorder and podocyte injury mediated by overactivation of endothelin A receptor are among the core pathological mechanisms of renal function deterioration in such patients. Atrasentan is a highly selective endothelin A receptor antagonist. It can competitively block the binding of endothelin to A receptor, reduce urinary protein excretion in the kidney and delay the progression of glomerulosclerosis. At present, it is mainly used to reduce the decline rate of estimated glomerular filtration rate and reduce the risk of end-stage renal disease in adult patients with chronic kidney disease complicated with type 2 diabetes mellitus who have progression risk, and it is one of the few specific treatment options for such patients in addition to renin-angiotensin system inhibitors.

At present, the global number of patients with chronic kidney disease complicated with type 2 diabetes mellitus has exceeded 100 million, and there is still a large supply gap in the market of targeted therapeutic drugs for this indication. Public data show that the global market size of atrasentan in 2023 was approximately USD 210 million, with an annual growth rate of more than 38%, and the core driving factor comes from the upgrading of the recommendation level for its renal protective effect in guidelines of various countries. In terms of competitive landscape, there are no generic drugs of this variety launched worldwide at present, and the market is still in the stage of exclusive supply by the original research developer. The generic drug R&D of domestic pharmaceutical enterprises is mostly in the pre-clinical or early clinical trial stage, and there is no relevant record of production application.

The original research enterprise of atrasentan is Abbott Pharmaceuticals, and the original research trade name is "Qelbree". The core compound patent of atrasentan will expire in 2029 in the United States, and the compound patent in China will expire in 2028. At present, the main dosage form approved by the original research developer is tablet, with two specifications of 0.75mg and 1.25mg. The original research tablet has been included in the FDA Reference Listed Drug Catalog, but has not been included in the China Catalog of Reference Preparations for Chemical Drugs so far. In terms of the domestic market, no atrasentan preparation has been approved for marketing, and there is no publicly available registration information of atrasentan API in A status or I status on the CDE API registration platform for the time being. (Data as of November 2024, please refer to the official website of CDE for the latest information)

In response to the current R&D and application requirements of this variety, CATO can provide a full set of atrasentan impurity reference standards. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most impurities can be supplied from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day, which can provide stable reference standard support for pharmaceutical enterprises in links such as API quality research and generic drug consistency evaluation.