Epinastine

Allergic diseases, as chronic immune system diseases with high clinical incidence, repeatedly recur and have a protracted course, which affects patients' quality of life for a long time. The advent of the second-generation non-sedating antihistamines has provided a safer option for the long-term management of such diseases. Epinastine belongs to the second-generation H1 receptor antagonists, with multiple mechanisms including mast cell membrane stabilization and inhibition of inflammatory mediator release. The incidence rate of central inhibitory side effects is far lower than that of the first-generation antihistamines. It is widely used clinically in the treatment of allergic rhinitis, urticaria, eczema, dermatitis, cutaneous pruritus, prurigo, vulgaris psoriasis with pruritus and other diseases, and is suitable for adults and child patients who meet the medication indications. With rapid onset of effect, long-lasting action and no obvious somnolence reaction, it is especially suitable for allergic people who need to maintain their daily work and study status.

The global antihistamine market size has continued to grow steadily in recent years. Among them, the global market size of epinastine related preparations was approximately USD 320 million in 2023, and the market size in China was approximately RMB 470 million, with the compound annual growth rate maintained at around 4%. In terms of the competitive landscape, the domestic market is currently dominated by domestic generic preparations, with the market share of the original research products being less than 10%. Domestic enterprises have gradually realized independent supply on the API production side. Epinastine has not been included in the national centralized volume-based procurement catalog, and the overall price of preparations remains stable.

The original research enterprise of epinastine is Boehringer Ingelheim Japan, with the original research trade name "Alesion", and its Japanese compound patent expired in 2007. The main dosage forms approved for the original research product include tablets, capsules and eye drops. The specification of the tablets is 10mg, that of the capsules is 10mg, and that of the eye drops is 0.05%. The original research preparations have been included in the Catalogue of Listed Drugs in China as reference preparations. At present, 12 epinastine APIs have obtained CDE registration numbers in China, among which 8 are in status A and can be used in association with domestic preparation applications. The domestically approved preparation varieties include epinastine capsules, epinastine tablets and epinastine eye drops. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for epinastine API. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. They are compliant with multiple regulations including Chinese Pharmacopoeia and FDA, and can meet the use requirements in different stages such as API R&D, quality research and consistency evaluation.