Momelotinib

In response to the clinical treatment needs of myeloproliferative neoplasms such as myelofibrosis, JAK inhibitors are the core medication regimen recommended by current guidelines. As a third-generation oral selective JAK1 inhibitor, momelotinib precisely targets the JAK-STAT signaling pathway. While inhibiting the release of pathological inflammatory factors, it can reduce the risk of adverse reactions such as anemia and thrombocytopenia caused by JAK2 inhibition. Clinically, it is mainly used for the treatment of adult patients with intermediate- and high-risk primary or secondary myelofibrosis. It can significantly improve the splenomegaly symptoms and systemic symptom burden of patients, providing a new treatment option for patients who are intolerant to previous generations of JAK inhibitors.

At present, the global market size of myelofibrosis treatment has exceeded 3 billion US dollars, and JAK inhibitors account for about 70% of the market share, among which the compound annual growth rate of third-generation JAK inhibitors is expected to reach 22%. For the domestic market, with the improvement of the diagnosis rate of myelofibrosis and the improvement of patients' access to medication, the market size of related therapeutic drugs is expected to exceed 2 billion yuan in 2030. Currently, only the innovator product of momelotinib has submitted a marketing application in China, and no generic drug has been approved. The market competition pattern is relatively loose, and there is a large space for generic substitution after the patent expires in the future.

The innovator company of momelotinib is G1 Therapeutics, and the innovator trade name is Ojnja. Its core compound patent expires in 2038 in the United States, and the Chinese compound patent expires in 2037. The main dosage form approved by the innovator at present is tablet, with specifications of 100mg and 200mg, which has been included in the FDA Reference Listed Drug Catalog. For the domestic market, the marketing application submitted by the innovator in 2024 has been accepted by the CDE. There is no registered API DMF number at present, and no momelotinib preparation produced by domestic enterprises has been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of momelotinib impurity reference standards. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are in regular stock. Orders placed before 16:00 can be shipped on the same day, which can efficiently meet the reference standard needs of pharmaceutical companies in the stages of API R&D, quality research and declaration.