Pirtobrutinib

In response to the clinical treatment needs of B-cell malignancies such as relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukemia, the new generation of Bruton's Tyrosine Kinase (BTK) inhibitors have gradually demonstrated differentiated advantages. Pirtobrutinib is a non-covalently binding BTK inhibitor, which can overcome the drug resistance problem of first-generation covalent inhibitors caused by the C481S mutation through non-covalent binding to the active site of BTK, while reducing the off-target inhibitory effect on other kinases. At present, its approved indications are mainly for adult patients with mantle cell lymphoma who have received at least one prior systemic therapy, as well as adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, providing a new treatment option for patients who are resistant or intolerant to traditional BTK inhibitors.

The global patient base of B-cell malignancies continues to expand, driving the steady growth of the BTK inhibitor market size. In 2023, the overall market size has exceeded USD 15 billion, among which the market growth rate of the new generation of non-covalent BTK inhibitors reached 62%, which is significantly higher than the average level of the segmented category. As the second non-covalent BTK inhibitor approved worldwide, pirtobrutinib is currently in the market introduction stage. Globally, 3 enterprises have submitted marketing applications for generic drugs, and no generic drug has been approved in China yet. With the subsequent expansion of indications and the advancement of medical insurance coverage, it has high market growth potential.

The original research enterprise of pirtobrutinib is Eli Lilly and Company, and the original brand name is Jaypirca. Its core compound patent in the United States will expire in 2039, and the core compound patent in China will expire in 2040. At present, the main dosage form approved for the original drug is tablet, with two specifications of 50mg and 100mg. The original product has been included in the FDA Reference Listed Drug Catalog, and the original preparation has not been marketed in China yet. Up to now, there is no valid registration number of pirtobrutinib on the API registration platform of China CDE, and no preparation product containing pirtobrutinib has been approved for marketing in China. (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 pirtobrutinib API, which can fully match the whole-process R&D needs such as impurity research and quality control. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, which can effectively help R&D and production enterprises reduce research costs and shorten project cycles.