Bilastine

Allergic diseases are chronic diseases with high incidence worldwide, and the clinical demand for non-sedating, highly selective antihistamines continues to rise. Bilastine is a second-generation non-sedating long-acting H1 antihistamine, which can block peripheral H1 receptors with high selectivity, hardly binds to H1 receptors, cholinergic receptors and 5-hydroxytryptamine receptors in the central nervous system, and has no obvious sedative or cardiac adverse reactions. It is mainly used clinically for the symptomatic treatment of allergic diseases such as allergic rhinitis and urticaria in adults and adolescents over 12 years old, and can quickly relieve symptoms such as nasal itching, sneezing, rash and itching. It has become a first-line drug recommended by diagnostic and treatment guidelines for allergic diseases in many countries.

The global bilastine market size was approximately USD 480 million in 2023, with a compound annual growth rate of 7.2% from 2019 to 2023. The growth drivers mainly come from the increasing prevalence of allergic diseases and the increasing preference of patients for antihistamines with low side effects. In terms of the domestic market, the terminal sales of public medical institutions exceeded RMB 320 million in 2023, and the growth rate has remained above 15% in the past three years. At present, the domestic preparation market is still dominated by the original research products, and the generic drugs of 3 enterprises have passed the consistency evaluation. As more generic enterprises enter the market in the future, the market accessibility will be further improved.

The original research enterprise of bilastine is FAES FARMA from Spain, and the original research trade name is BILASITA®. Its main compound patent in Europe expired in 2021, and the expiration date of the compound patent in China is 2023. The main dosage form approved for the original research product is tablet, with specifications including 20mg and 10mg, which has been included in the reference preparation catalog of the European EMA and the China NMPA. In terms of domestic API registration, 8 registration entries of bilastine API can be queried on the CDE platform at present, among which 5 have been converted to "A" status and can be legally supplied for domestic preparation production; bilastine tablets from the original research enterprise and multiple domestic generic pharmaceutical 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 bilastine impurity reference standards, covering all categories such as process impurities and degradation impurities. Most products have sufficient stock reserves, and in-stock orders placed before 16:00 can be shipped on the same day. All reference standards comply with the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of different scenarios such as API R&D, quality research and consistency evaluation.