Ruxolitinib

As a type of clonal hematopoietic stem cell disease, myeloproliferative neoplasms have long faced the clinical dilemma of limited treatment options and poor patient prognosis. The advent of ruxolitinib has brought breakthrough progress to the treatment of such diseases. As the world's first approved JAK1/2 tyrosine kinase inhibitor, it selectively inhibits the abnormal activation of the JAK-STAT signaling pathway to block the proliferation of abnormal cells and the release of inflammatory factors at the pathogenesis level. It has currently been approved for patients with intermediate- and high-risk primary myelofibrosis, myelofibrosis secondary to polycythemia vera, and myelofibrosis secondary to essential thrombocythemia. Meanwhile, its clinical application is being expanded in indication areas such as graft-versus-host disease, covering adults and adolescents over 12 years old.

The global market size of ruxolitinib exceeded USD 4 billion in 2022, with a compound annual growth rate of over 12% from 2018 to 2022. On the demand side, driven by the improved diagnosis rate of myelofibrosis and the expansion of indications, there is still room for steady growth. In terms of the domestic market, the original research product was priced high after entering China in 2017. After being included in the National Medical Insurance Catalog in 2019, the payment threshold for patients was significantly reduced, and the terminal sales in public medical institutions exceeded RMB 3 billion in 2023. At present, more than 10 domestic pharmaceutical companies have deployed in generic drug R&D, among which 3 companies have had their oral preparations approved for marketing. After the implementation of volume-based procurement, market competition will further tilt towards the dimensions of cost control and supply chain stability.

The original research enterprise of ruxolitinib is Novartis, and the original brand name is Jakafi. Its core compound patent in the United States expires in 2027, and the core compound patent in China expires in 2026. The currently approved main dosage form is tablets, with specifications including 5mg, 10mg, 15mg, 20mg and 25mg. The original preparation has been included in the China Listed Drug Catalogue and is also listed as a reference preparation by the FDA. At present, more than 30 enterprises in China have submitted registration applications for ruxolitinib API, among which nearly 20 registrations are in status A (approved for use in marketed preparations), and 3 domestic ruxolitinib tablets have been approved for marketing. (Data as of June 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for ruxolitinib API, which meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most products are in regular stock. Spot orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard needs of pharmaceutical enterprises in R&D, quality research and production links.