Cevimeline

Sjögren's syndrome is an autoimmune disease whose core manifestation is hyposecretion of the lacrimal and salivary glands. The global patient base exceeds 10 million, and there has been a long-term lack of targeted improvement solutions for the symptoms of dry mouth and dry eyes, which seriously affects the quality of life of patients. Cevimeline belongs to the class of M cholinergic receptor agonists. It can specifically activate the M₁ and M₃ receptors on the salivary glands and lacrimal glands to stimulate the secretory function of the glands. Clinically, it is mainly used to improve the symptoms of dry mouth and dry eyes in patients with Sjögren's syndrome, and can also be used for the symptomatic treatment of xerostomia after radiotherapy, providing a targeted intervention option for patients who have long been troubled by hyposecretion.

At present, the global market size of cevimeline is stable at around USD 320 million, with a compound annual growth rate of 4.1%. The growth drivers mainly come from the increased diagnosis rate of Sjögren's syndrome and the expanded demand for the management of adverse reactions after radiotherapy for head and neck tumors. In terms of the competitive landscape, the original research product accounts for nearly 60% of the global market share, and generic drug companies are mostly concentrated in India and China. With the expiration of core patents, the substitution space for generic drugs is gradually released. At present, no cevimeline preparation from local enterprises has been approved for marketing in China, and the supply of APIs is in the market introduction stage, with considerable potential demand.

The original research enterprise of cevimeline is Japan's Shionogi & Co., Ltd., with the original brand name "Evoxac". Its US compound patent expired in 2019, and the core compound patent in China expired in 2021. The main dosage form approved for the original product is capsules, with a specification of 30mg. The original capsule has been included in the FDA Reference Listed Drug Catalog, but it has not yet been included in the *Catalog of Chemical Drugs* in China. In terms of domestic API registration, there is no publicly available approved A-status registration number for cevimeline API, nor is there any domestically produced cevimeline preparation approved for marketing, and only a small number of enterprises are in the R&D and declaration stage of APIs. (Data as of June 2025, please refer to the official website of CDE for the latest information.)

CATO can provide a full set of impurity reference standards for cevimeline API. The products meet the relevant regulatory requirements of the Chinese Pharmacopoeia and FDA at the same time, and most categories are available directly from stock. Spot orders submitted before 16:00 can be shipped on the same day, fully meeting the compliance and efficiency requirements of pharmaceutical enterprises at all stages of R&D and quality research.