Ivosidenib

As a precision targeted anti-tumor drug targeting IDH1 mutations, ivosidenib is an isocitrate dehydrogenase-1 (IDH1) inhibitor. It reduces the production of the carcinogenic metabolite 2-hydroxyglutaric acid by targeted inhibition of the activity of mutant IDH1 enzyme, thereby inducing tumor cell differentiation. The currently approved indications include relapsed or refractory acute myeloid leukemia carrying IDH1 mutations, and locally advanced or metastatic cholangiocarcinoma. The main applicable population is adult patients confirmed to have IDH1 susceptible mutations through testing, which fills the clinical gap that there is no targeted treatment regimen for patients with such mutations.

The global market size of ivosidenib was approximately USD 420 million in 2023, and it is expected to grow to around USD 1 billion in 2028 at a compound annual growth rate of 18.7%. The current market pattern is still dominated by the original research product, and no generic drug has been approved for marketing in China yet. With the increase in the penetration rate of precision testing in the fields of acute myeloid leukemia and cholangiocarcinoma, the medication demand of the corresponding patient groups will be further released.

The original research enterprise of ivosidenib is Servier, and the original trade name is Tibsovo. Its core compound patent in the United States will expire in 2032, and the compound patent in China will expire in 2031. The original marketed dosage form is tablet with a specification of 250mg, which has been included in the FDA Reference Listed Drug Catalog, and also included in the *Catalog of Reference Preparations for Chemical Drugs (Third Batch)* of China. Up to now, a number of domestic enterprises have submitted DMF registration applications for ivosidenib API, and the original preparation and 2 domestic generic preparations have been approved for marketing by the NMPA. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for ivosidenib API. Most products are available from stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the use requirements of reference standards in the process of API R&D, quality research and production.