Ixabepilone

In response to the clinical pain point that there is a lack of effective regimens for patients with advanced breast cancer after developing resistance to taxane and anthracycline therapies, ixabepilone, as a new generation of epothilone microtubule inhibitor, has demonstrated unique clinical value. Its mechanism of action is similar to that of taxanes, but there are differences in binding sites. By promoting tubulin polymerization and inhibiting microtubule depolymerization to block cell mitosis, it can overcome problems such as β-tubulin mutations and overexpression of multidrug resistance proteins related to taxane resistance. The drug, used alone or in combination with capecitabine, is mainly indicated for the treatment of metastatic or locally advanced breast cancer, especially for patients who have failed previous anthracycline and taxane therapies, providing an important later-line treatment option for patients with advanced refractory breast cancer.

At present, the global market size of ixabepilone is relatively limited, reaching approximately USD 120 million in 2023, with a relatively gentle overall growth, which is mainly restricted by the competition of generic drugs after patent expiration and the diversion of similar innovative drugs. The domestic market is still in the layout stage, with no generic drug varieties approved for marketing yet, and the clinical accessibility of the original research product is low. With the continuous release of domestic treatment demand for advanced breast cancer, it has high market penetration potential in the future. In terms of competitive landscape, a number of domestic enterprises have submitted clinical registration applications for the API and preparations of this variety, the track is still in the early development stage, and first-mover enterprises have significant market advantages.

The original research enterprise of ixabepilone is Bristol-Myers Squibb, and the original research trade name is Ixempra. Its core compound patent in the United States expired in 2021, and the core compound patent in China also expired in 2021. The main dosage form approved for the original research product is injection, with specifications of 15 mg/vial and 45 mg/vial. It has been included in the FDA Reference Listed Drug Catalog, and has not been included in the *Chinese Catalog of Chemical Medicines* yet. No original research preparation of this variety has been approved for marketing in China, and the API registration platform has not included the approved registration number of ixabepilone API either. At present, only a small number of enterprises have submitted clinical trial applications. (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 ixabepilone. Most products are available from stock, and orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the various use needs of reference substances in the process of API R&D, quality research and registration declaration.