Pralatrexate

For relapsed/refractory peripheral T-cell lymphoma (PTCL), a lymphoid malignancy with extremely poor clinical prognosis, the objective response rate of existing conventional chemotherapy regimens is less than 30%, and the median overall survival of patients is usually no more than 18 months. As a new generation of antifolate metabolic antineoplastic drug, pralatrexate specifically inhibits dihydrofolate reductase and polyglutamyl synthetase, blocks the folate-dependent pathways in the DNA and RNA synthesis process of tumor cells, and exerts a stronger targeted killing effect on T lymphocyte tumors with high expression of folate transporters. It is currently approved for monotherapy of relapsed/refractory peripheral T-cell lymphoma, and is also included in some guidelines as a second-line treatment option for mycosis fungoides and Sézary syndrome, making it one of the few targeted drugs in the field of PTCL treatment.

The global market size related to pralatrexate was approximately USD 170 million in 2023. Driven by the improvement of PTCL diagnosis rate and the exploration of combination therapy regimens, the compound annual growth rate is expected to remain at around 6.2% by 2028. At present, the original research product still dominates the global market, while the domestic market is still in its initial stage. As of 2024, only a small number of enterprises have submitted marketing applications for generic drugs, which have not yet been included in the centralized procurement catalog. The market competition pattern is relatively loose, and there is no publicly verified segmented market size data.

The original research enterprise of pralatrexate is Spectrum Pharmaceuticals (US), with the original brand name Folotyn. The core compound patent will expire in 2027 in the United States, while the compound patent in China expired in 2022. The dosage form approved for the original product is injection, with specifications of 20 mg/vial and 40 mg/vial. It 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 is no approved registration number for pralatrexate active pharmaceutical ingredient (API) corresponding to the original product on the domestic API registration platform. Only the original imported injection was approved for marketing by the National Medical Products Administration in 2020, and no domestic preparation has been approved yet. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of pralatrexate impurity reference standards. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and fully meet the reference standard use needs in the whole process of API R&D, quality research and registration declaration.