Bepotastine

As a chronic disease with high incidence globally, allergic diseases are currently faced with the issue that existing antihistamine drugs often have adverse reactions such as central sedation and dry mouth, which limits patients' long-term medication options. Betastine belongs to the second-generation non-sedating H1 antihistamines, which can block histamine H1 receptors with high selectivity, and meanwhile inhibit eosinophil infiltration and inflammatory mediator release. It hardly penetrates the blood-brain barrier, so the incidence rate of central adverse reactions is extremely low. Clinically, it is mainly used for the treatment of allergic rhinitis, urticaria, skin pruritus and other diseases. It is applicable to both adult patients and children over 7 years old, and is a preferred second-line antihistamine drug that balances safety and effectiveness.

The global betastine market size has maintained steady growth in recent years. In 2023, the market size was approximately USD 420 million, with a compound annual growth rate of around 4.8%. The Chinese market is the main growth engine. Driven by factors such as the rising prevalence of allergic diseases and the expanding demand for pediatric medications, the domestic market has achieved a compound annual growth rate of 7.2% in the past three years. The current market is dominated by original research products, with a small number of approved domestic generic drugs, and the overall competitive landscape is relatively relaxed. With the gradual expansion of the coverage of centralized procurement, the substitution space for generic drugs is continuing to be released.

The original research enterprise of betastine is Japan's Mitsubishi Tanabe Pharma, and the original research brand name is "Talion". Its core compound patent expired in 2018 in major markets such as Japan and the United States, and the compound patent in China expired in 2017. The main dosage form of the original research product is oral tablet, with a conventional specification of 10mg. It has been included in the *Catalogue of Chemical Reference Preparations* of China, and is also included in the FDA Reference Preparations Catalogue. Up to now, the betastine APIs of multiple Chinese enterprises have obtained CDE registration numbers, all with the status of A, and there are also multiple generic varieties of domestic betastine tablets that 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 betastine API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of pharmaceutical enterprises in impurity research, quality control and other aspects during R&D and production, helping enterprises efficiently promote the generic drug consistency evaluation and marketing declaration work.