Bexarotene

Cutaneous T-cell lymphoma, as a type of heterogeneous malignant tumor, has long had clinical pain points of low remission rate and high recurrence risk in conventional clinical chemotherapy regimens. The advent of bexarotene provides a brand-new treatment option for such refractory patients. As a third-generation highly selective retinol X receptor (RXR) agonist, this drug can regulate the expression of genes related to cell proliferation and differentiation by activating RXR receptors, induce apoptosis of tumor cells and inhibit their abnormal proliferation. It is clinically mainly used for the treatment of patients with cutaneous T-cell lymphoma who have received at least one prior systemic therapy, and can also be used for the treatment of other malignant tumors such as Kaposi's sarcoma after evaluation by clinicians.

At present, the selection of targeted therapeutic drugs for cutaneous T-cell lymphoma is very limited. As a core therapeutic drug in this field, bexarotene maintains a steady growth trend in its global market size. In 2023, its global market size was approximately USD 120 million, with a compound annual growth rate of around 4%. In terms of competitive landscape, the original research product still occupies the major global market share. At present, only a small number of pharmaceutical companies have achieved the launch of generic drugs worldwide, and China is still in the early stage of generic drug research and development. The market supply gap is relatively significant, and the industry's demand for high-quality active pharmaceutical ingredients continues to rise.

The original research enterprise of bexarotene is Valeant Pharmaceuticals, with the original brand name Targretin. Its compound patent in the United States expired in 2016, and the compound patent in China expired in 2021. The main dosage forms of the original research product include soft capsules and topical gel. The specification of the soft capsule is 75 mg, and the specification of the gel is 1% (10 g: 0.1 g). The original research product has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in China's *Catalog of Reference Preparations for Chemical Drugs*. There are currently no approved bexarotene preparations on the market in China, and there is no publicly available valid API registration number on the CDE API registration platform. Relevant generic drug research and development is still in the clinical promotion stage. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for bexarotene API. Most of the products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. They can meet the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for various stages of research such as drug development and quality research.