Fovinaciclib Citrate

As a malignant hematological tumor, myelofibrosis is often accompanied by severe complications such as splenomegaly and anemia in patients, and traditional treatment regimens have limited benefits. The advent of vepdecirib citrate has filled the treatment gap in this field. It is a highly selective cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, which blocks the retinoblastoma protein phosphorylation pathway mediated by CDK4/6 and arrests tumor cells from the G1 phase to the S phase, thereby inhibiting the proliferation of tumor cells. At present, this drug is mainly indicated for adult patients with intermediate or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis. There is no need to adjust the initial dose according to the patient's baseline platelet count, which reduces medication restrictions and provides a new option for patients who are intolerant to other CDK4/6 inhibitors.

Globally, the number of patients with myelofibrosis is increasing year by year, driving the continuous expansion of the market size of vepdecirib citrate. In 2023, the global sales of this drug have exceeded 900 million US dollars, with a compound annual growth rate of more than 35%. At present, the global market is still dominated by the original research product, and only a few countries and regions have accepted generic declaration applications. The domestic market is still in the introduction period. With the improvement of domestic patients' awareness of this innovative therapy and the expectation of the implementation of medical insurance negotiations, the domestic market size is expected to exceed 1.5 billion yuan in the next 3-5 years. At present, more than 10 domestic pharmaceutical companies have submitted registration declarations for this API, and the competition in the generic drug track is gradually heating up.

The original research enterprise of vepdecirib citrate is G1 Therapeutics, and the original research trade name is Cosela. The expiration date of the core compound patent in the United States is 2037, and the expiration date of the core compound patent in China is 2036. The main approved dosage form is tablets, with specifications including 75mg, 100mg and 150mg. The original research preparation has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in China's *Catalog of Reference Listed Drugs for Chemical Drugs*. As of the retrieval time point, the vepdecirib citrate APIs of a number of domestic enterprises have completed registration with the CDE, the original research preparation has not yet been approved for marketing in China, and the generic drug marketing applications submitted by 3 domestic pharmaceutical companies are in the review and approval stage. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for vepdecirib citrate, most of which are in stock. For in-stock orders placed before 16:00, delivery can be made on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can meet the full-process needs of pharmaceutical companies from API R&D, quality research to registration declaration.