Fostamatinib

Immune thrombocytopenia is an acquired autoimmune hemorrhagic disease. For a long time, clinical treatment for this disease has been plagued by the pain points of insufficient remission rate and high recurrence rate. The advent of fostamatinib has provided a brand-new treatment option for such patients. It is an oral spleen tyrosine kinase (SYK) inhibitor. By inhibiting the SYK-mediated platelet destruction signaling pathway, it increases platelet count without significantly suppressing immune system function. Currently, it is mainly used for adult patients with chronic immune thrombocytopenia who have insufficient response to glucocorticoid and immunoglobulin therapy or have relapsed. Meanwhile, clinical exploration in the field of autoimmune diseases such as warm antibody autoimmune hemolytic anemia is also progressing steadily.

The global market size related to fostamatinib has exceeded 1.2 billion US dollars in 2023, with a compound annual growth rate of around 21% in the past three years. The growth momentum mainly comes from the rising global prevalence of immune thrombocytopenia and the expansion of clinical pipelines. The Chinese market is still in the early stage of commercialization. At present, only the original research product has been approved for marketing and has not yet been included in the national centralized procurement catalogue. With the expansion of indication coverage, the domestic market size is expected to exceed 300 million yuan in 2027. At present, more than 10 local pharmaceutical companies have laid out generic drug research and development, and competition in the track will gradually heat up after the patent expires.

The original research enterprise of fostamatinib is Astellas Pharma of Japan, and the original research trade name is "Sykamra". The expiration time of its core compound patent in the United States is 2027, and the expiration time of the core compound patent in China is 2028. The main dosage form currently approved is tablet, with specifications of 100mg and 150mg. The original research preparation has been included in the *Catalogue of Reference Preparations for Chemical Drugs* issued by the NMPA, and is also included in the FDA Reference Preparations Catalogue. In terms of domestic API registration, as of now, there is no approved fostamatinib API registration number for any enterprise. The only preparations approved for marketing in China are the imported products of the original research company Astellas, and no local generic drugs have been approved. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for fostamatinib API, which fully meets the needs of the whole process of drug research and development, quality research and compliance declaration. Most products are in stock. For in-stock products, orders placed before 16:00 can be shipped on the same day. All reference standards meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can solve the supply problem of impurity reference standards in a one-stop manner.