Pemirolast

Allergic diseases are a category of chronic diseases with high incidence worldwide. Current treatment regimens, such as antihistamines and glucocorticoids, still have clinical pain points including drug resistance and adverse reactions caused by long-term use. Pemirolast belongs to the class of allergy mediator release inhibitors. It specifically inhibits the phosphodiesterase activity of mast cells and basophils to reduce the release of allergy mediators such as histamine, leukotrienes and prostaglandins, and at the same time can directly antagonize the biological effects of inflammatory mediators. Clinically, it is mainly used for the long-term prevention and treatment of bronchial asthma, and can also be used for the intervention of allergic diseases such as allergic rhinitis, urticaria and allergic conjunctivitis. Its applicable population covers adults and pediatric patients who meet the dose adjustment criteria, and it is an allergic disease control drug that combines safety and long-term efficacy.

The global market size of pemirolast-related preparations is stably around 420 million US dollars, with a compound annual growth rate of approximately 3.1%. The growth momentum mainly comes from the continuous increase in the prevalence of allergic diseases and the improvement of primary treatment penetration. In terms of the domestic market, the annual sales of pemirolast preparations at the terminal of public medical institutions exceed 210 million yuan. The current competitive landscape is dominated by generic drugs, with the original research product only accounting for about 12% of the market share. Five domestic enterprises have been approved to produce oral preparations, and three enterprises have been approved to produce eye drop dosage forms. It has not yet been included in the national centralized volume procurement catalogue, and there is still considerable room for domestic substitution in the API supply chain.

The original research enterprise of pemirolast is Japan's Kyorin Pharmaceutical Co., Ltd., and the original brand name is "Alegysal". The core compound patent expired in Japan in 2004, and the US market patent expired in 2007. The main dosage forms approved for the original research include tablets (10mg), granules (0.1%) and eye drops (5ml:5mg), among which tablets and eye drops have been included in the China Listed Drug Catalogue as reference preparations. In terms of domestic API registration, as of now, a total of 3 enterprises have obtained approval for the registration of pemirolast APIs, all with the status of A, and more than 10 domestic enterprises have had their preparation products approved for marketing. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of impurity reference standards for pemirolast APIs. Related products comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA. Most products support spot supply, and spot orders placed before 16:00 can be shipped on the same day, which can fully meet the reference standard use needs of the whole process of API R&D, quality research and production.