Duvelisib

The clinical treatment of relapsed/refractory hematological malignancies has long been faced with the pain points of limited treatment options and insufficient survival benefits for patients. As the world's first approved dual inhibitor of PI3K-δ and PI3K-γ, duvelisib simultaneously inhibits two key kinase targets to block the proliferation and survival signaling pathways of malignant B cells, and can also regulate the function of immune cells in the tumor microenvironment. At present, this drug is mainly used for adult patients with relapsed/refractory follicular lymphoma who have received at least two lines of systemic therapy in the past, and can also be used for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma, providing a new option for hematological tumor patients who have no available drugs after multiple lines of treatment.

The global market size related to duvelisib was approximately USD 120 million in 2022. Driven by factors such as the rising prevalence of hematological tumors, the expansion of later-line treatment demand and the improvement of accessibility in emerging markets, the compound annual growth rate is expected to remain at around 18% by 2025. The current market is dominated by original research products, and no generic drug has been approved for marketing in China. With the expiration of original research patents one after another, the market space for domestic generic drug development is considerable in the future; there is no publicly verifiable authoritative data on the competitive landscape of the segmented market for the time being.

The original research enterprise of duvelisib is Verastem Oncology, and the original research trade name is Copiktra. Its core compound patent in the United States expires in 2027, and the compound patent in China will expire in 2028. The main dosage form approved for the original research product is capsule, with specifications including 25mg and 15mg. It has been included in the FDA Reference Listed Drug Catalog, but has not yet been included in the *List of Chemical Drugs* in China. No original research preparation has been approved for marketing in China yet. As of now, there is no valid registration number (status A or status I) of duvelisib in the CDE API registration database, and no domestic enterprise has been approved to produce duvelisib-related preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

In response to the impurity research needs in the process of duvelisib generic drug development, CATO can provide a full set of impurity reference standards for this API. Most of the products are in stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can provide stable support for R&D enterprises to shorten the impurity preparation cycle and reduce research risks.