Suplatast Tosilate

The pathogenesis of allergic diseases such as bronchial asthma and allergic rhinitis is closely related to T cell activation and excessive secretion of Th2 cytokines. Traditional antihistamines and glucocorticoids have the limitation of adverse reactions after long-term use. As a selective Th2 cell inhibitor, suplatast tosilate provides a safer long-term control option for such chronic allergic diseases. It inhibits the activity of phosphodiesterase Ⅳ, reduces the release of pro-inflammatory factors such as IL-4 and IL-5, and lowers eosinophil infiltration. Clinically, it is mainly used for the long-term prevention and treatment of bronchial asthma in adults and children, and can also be used for the adjuvant treatment of allergic rhinitis and atopic dermatitis, especially suitable for the patient group that needs long-term control of allergic symptoms and cannot tolerate the side effects of hormones.

The global market size of suplatast tosilate maintains a steady growth trend. In 2023, the market size was approximately USD 180 million, with a compound annual growth rate of around 5%. The growth momentum mainly comes from the rising prevalence of allergic diseases and the increasing demand for long-term management of adult allergies. In terms of the competitive landscape, the original research product still occupies a dominant position in major markets such as Japan and China. The domestic generic drug layout is still in the initial stage. At present, only 3 enterprises have submitted generic drug marketing applications, and no variety has passed the consistency evaluation. The relevant centralized procurement rules have not yet covered this variety, the market competition is relatively mild, and the market space for API and generic drug development is sufficient.

The original research enterprise of suplatast tosilate is Japan Sawai Pharmaceutical Co., Ltd., with the original trade name "Suplast". Its core compound patent expired globally in 2018. The mainstream dosage form of the original research product is granules, with specifications of 50mg/packet and 100mg/packet. It has been included in the Japanese Orange Book Reference Preparations Catalogue, and is also included in China's *Catalogue of Chemical Reference Preparations (Fifth Batch)*. In terms of domestic API registration, 2 enterprises have obtained A status for their suplatast tosilate APIs through CDE registration, and another 5 enterprises are in the review and publicity stage. Domestically, the imported original research product and the preparation products of 2 domestic enterprises have been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of suplatast tosilate impurity reference standards, which can cover the whole process requirements of impurity qualitative identification, quantitative detection and stability research. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully meet the relevant experimental requirements of API research and development, quality control and generic drug consistency evaluation.