Belinostat

Peripheral T-cell lymphoma is a subtype of non-Hodgkin's lymphoma with high invasiveness and poor prognosis. The clinical response rate of existing second-line treatment regimens has been less than 30% for a long time, and the clinical demand is urgent. Belinostat belongs to the hydroxamide class of histone deacetylase (HDAC) inhibitors. It selectively inhibits the activity of class I and class II HDACs, regulates the expression of tumor suppressor genes in tumor cells, and induces tumor cell cycle arrest and apoptosis. Currently, its approved indication is relapsed or refractory peripheral T-cell lymphoma, providing a new treatment path for patients who have no alternative drugs after multiple lines of treatment.

There are approximately 45,000 new cases of peripheral T-cell lymphoma worldwide each year, of which China accounts for more than 30%. In 2023, the global market size of HDAC inhibitors reached USD 1.87 billion, among which products targeting the peripheral T-cell lymphoma indication accounted for about 27%. Belinostat maintains a compound annual growth rate of 11.2% by virtue of its lower incidence of hematological adverse reactions. At present, only a few pharmaceutical companies worldwide have achieved large-scale production of this API, and no generic preparation has been approved in China, so the market supply and demand gap is obvious.

The original developer of belinostat is Spectrum Pharmaceuticals, and the original brand name is Beleodaq. Its core compound patent in the United States expired in 2027, and the compound patent in China will expire in 2028. The approved dosage form of the original product is injection, with a specification of 500 mg per vial. It has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the *List of Chemical Drugs* in China. No domestic enterprise has obtained the marketing approval for belinostat API, there is no relevant A-status registration number on the CDE API registration platform, and no belinostat preparation produced by domestic enterprises has been approved for marketing either. (Data as of November 2024, please refer to the official CDE website for the latest information)

In response to the R&D and quality control requirements for belinostat, CATO can provide a full set of impurity reference standards for this API. Most of the products are available from stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and fully meet various technical requirements of pharmaceutical enterprises in the stages of declaration and quality research.