Levocabastine

Allergic rhinitis is a chronic respiratory disease with high incidence globally, affecting over 1 billion patients who suffer from symptoms such as sneezing, nasal itching and rhinorrhea for a long time. There is an urgent clinical need for topical anti-allergic drugs with high efficacy and low side effects. Levocabastine is a second-generation highly selective histamine H1 receptor antagonist. It can rapidly inhibit the inflammatory response induced by allergic mediators by competitively blocking the binding of histamine to H1 receptors, with no obvious central sedative effect. It is mainly used clinically for the symptomatic treatment of allergic rhinitis and allergic conjunctivitis, is safe for both adults and children, and is a first-line drug for topical anti-allergic treatment.

The global market size of levocabastine-related preparations is approximately USD 420 million, with a compound annual growth rate of 3.8% in the past three years. The growth mainly comes from the increase in the diagnosis and treatment penetration rate of allergic diseases in children. The domestic market is currently dominated by generic drugs, with the original research product accounting for less than 15%. Nasal spray preparations from more than 12 enterprises have been approved for marketing, and the localization rate of API has reached more than 90%. It is not included in the national centralized volume-based procurement scope, and the overall market competition is relatively sufficient.

The original research enterprise of levocabastine is Janssen Pharmaceutica N.V. of Belgium, with the original research trade name "Livostin". Its core compound patent expired globally in 2011. The core dosage form is nasal spray with a specification of 10ml:5mg. This dosage form has been included in the Chinese *Catalogue of Reference Preparations for Chemical Drugs* and is also listed in the FDA Reference Preparations Catalogue. In China, 7 enterprises have obtained CDE registration (status A) for levocabastine API, and a total of 13 levocabastine nasal spray preparations, including the original imported product, 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 levocabastine API, covering all pathway-related reference materials such as synthetic process impurities and degradation impurities. 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 compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can meet the full-process R&D needs such as impurity research, quality control and registration declaration.