Amlexanox

The prevalence of allergic diseases and inflammatory oral mucosal diseases is increasing year by year worldwide, and differentiated therapeutic drugs with both anti-inflammatory and anti-allergic effects have gradually become a rigid clinical demand. Amlexanox is an anti-inflammatory and anti-allergic drug with dual effects of leukotriene receptor antagonist and mast cell stabilizer. It exerts multiple effects of anti-inflammation, anti-allergy and promoting mucosal repair by inhibiting the release of inflammatory mediators such as histamine and leukotriene, and blocking the binding of inflammatory mediators to receptors at the same time. It is mainly used clinically to treat recurrent aphthous ulcer, allergic rhinitis, bronchial asthma and other diseases. Among them, the oral patch dosage form, with high local administration concentration and low systemic side effects, is the first-line treatment option for recurrent oral ulcer in adults and adolescents over 12 years old.

At present, the global market size of amlexanox is approximately USD 120 million, with a compound annual growth rate maintained at around 4.2%. The growth momentum mainly comes from the continuous expansion of the demand for drugs for oral mucosal diseases. The market size in China is approximately RMB 110 million, among which generic preparations account for more than 90% of the market share, and the market share of the original research product is less than 10%. This variety has not been included in the scope of the national centralized volume-based procurement, and the supply pattern of API is relatively scattered. At present, no more than 5 enterprises in China have production qualifications, and the market supply and demand relationship remains stable.

The original research enterprise of amlexanox is Takeda Pharmaceutical Company Limited of Japan, with the original research brand name "Solfa", and its core compound patent expired globally in 2009. The main dosage forms approved for the original research product include 50mg oral tablet, 2% oral patch and 0.2% topical ointment. Among them, the 2% oral patch is the mainstream reference listed drug worldwide, and has been included in the FDA Orange Book Reference Listed Drug Catalog and China's *Catalog of Reference Listed Drugs for Chemical Drugs (Third Batch)*. Up to now, there are 3 pieces of amlexanox API registration information on the API registration platform of China CDE, among which 2 are in Status A. The amlexanox oral patches and oral tablets of several domestic enterprises have been approved for marketing. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for amlexanox API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day, which can meet the use needs of different stages such as R&D, quality research and registration declaration. All products meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide reliable support for enterprises to simplify the impurity research process and shorten the declaration cycle.