Mizolastine

The recurrent attacks of allergic diseases such as allergic rhinitis and urticaria often bring significant distress to patients' quality of life. The advent of second-generation non-sedating H1 antihistamines has provided a safer option for the long-term management of these diseases. As a representative variety of second-generation H1 antihistamines, mizolastine not only blocks histamine H1 receptors with high selectivity, but also has a dual mechanism of action of inhibiting the release of histamine from mast cells and inhibiting inflammatory mediators such as leukotrienes, with no obvious central sedation or cardiotoxicity. It is mainly clinically used for the symptomatic treatment of seasonal allergic rhinitis, perennial allergic rhinitis, urticaria and other skin allergic symptoms in adults and children over 12 years old, and is a first-line drug option for the long-term control of allergic diseases.

At present, the global prevalence of allergic diseases continues to rise, driving the steady expansion of the second-generation antihistamine market. Public data shows that the overall market size of domestic antihistamines has exceeded 8 billion yuan, among which mizolastine, with its differentiated advantage of dual anti-inflammatory effects, accounts for about 4% of the market share in the segment, and its compound annual market growth rate has remained at around 7% in the past three years. In terms of competitive landscape, the original research product still accounts for nearly 60% of the market share. At present, 3 domestic enterprises have obtained the approval documents for mizolastine preparations, and the supply of active pharmaceutical ingredients (APIs) is still in the early stage of domestic substitution, and large-scale homogeneous competition has not yet emerged.

The original research enterprise of mizolastine is Sanofi, and the original brand name is "Mizollen". Its core compound patent expired in 2013. The main dosage form of the original marketed product is sustained-release tablet with a specification of 10 mg. This product has been included in the China Listed Medicines Catalogue as the reference listed drug (RLD), and is also included in the FDA Reference Listed Drug Catalog. According to the domestic CDE API Registration Platform, 4 enterprises have submitted registrations for mizolastine APIs at present, among which 2 have been activated with A status and can be associated with domestic preparation declarations. The domestically approved and marketed mizolastine preparations include the original imported sustained-release tablets and generic sustained-release tablets from 2 domestic enterprises. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of mizolastine impurity reference standards, fully covering impurities from the synthesis process, degradation impurities and official reference standards. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are available in stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet the full-process needs of API R&D, quality research and routine quality control.