Pemigatinib

Cholangiocarcinoma is a highly malignant gastrointestinal tumor, with a response rate to traditional chemotherapy of less than 20%. FGFR2 fusion/rearrangement is its key driver mutation, and the launch of pemigatinib has filled the treatment gap for this specific patient population. As a small-molecule inhibitor of fibroblast growth factor receptor (FGFR) 1/2/3, it selectively blocks the phosphorylation process of FGFR kinase and inhibits the abnormally activated downstream signaling pathways, thereby inhibiting the proliferation and migration of tumor cells. Currently, its main indication is for adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusion or rearrangement. Meanwhile, it has also demonstrated considerable efficacy in clinical studies for FGFR mutation-related tumors such as relapsed/refractory myeloid/lymphoid neoplasms and relapsed metastatic cervical cancer.

The annual number of new cholangiocarcinoma cases worldwide exceeds 210,000, among which approximately 15% to 20% of patients have FGFR2 fusion mutations, corresponding to a continuously expanding potential applicable population for pemigatinib. In 2023, its global market size has exceeded USD 420 million, with a compound annual growth rate of 38.7% in the recent three years. With the accelerated progress of solid tumor indication expansion, the global market size is expected to exceed USD 1.2 billion by 2028. Currently, the original research product still holds a dominant position. In the Chinese market, more than 10 pharmaceutical companies have submitted marketing applications for generic drugs. Starting from 2024, as core patents expire successively, the penetration rate of generic drugs is expected to increase rapidly.

The original research enterprise of pemigatinib is Incyte Corporation, and the original research trade name is Pemazyre. Its compound patent in China expires in December 2024, and the crystal form patent is expected to expire in 2036. The dosage form approved for the original research product is tablet, with specifications including 4.5 mg, 9 mg and 13.5 mg. It has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the NMPA, and is also a reference preparation recognized by the FDA. At present, 2 pemigatinib API products in China have passed the CDE review and public announcement (A status), and the original research product and 3 domestic generic drug preparations have been approved for marketing by the NMPA. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for pemigatinib API, covering all types such as synthetic process impurities, degradation impurities and enantiomers. Most products are in stock. For in-stock orders placed before 16:00, same-day delivery can be realized. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and the FDA, and can fully meet various reference standard needs of pharmaceutical enterprises in the stages of API R&D, quality research and registration application.