雷莫司琼

Chemotherapy-induced nausea and vomiting (CINV) is one of the most common adverse reactions in tumor patients during treatment, which severely affects treatment compliance and quality of life. 5-HT3 receptor antagonists are the core medications for the prevention and treatment of such symptoms. Ramosetron is a second-generation highly selective 5-HT3 receptor antagonist. It potently blocks the binding of 5-HT released by chromaffin cells in the gastrointestinal mucosa to 5-HT3 receptors in the central nervous system and vagus nerve endings, thereby inhibiting the signal transduction of the vomiting reflex. Its antiemetic effect can last for up to 24 hours, and it has definite efficacy against acute and delayed CINV caused by highly emetogenic chemotherapeutic drugs such as cisplatin. It can also be used for the prevention of nausea and vomiting after surgical anesthesia, and the applicable population includes malignant tumor patients receiving chemotherapy and patients requiring general anesthesia surgery.

The global ramosetron market size has maintained a steady growth trend in recent years. In 2023, the market size was approximately USD 120 million, with the Chinese market accounting for more than 45%, and the compound annual growth rate remaining at around 6%. In terms of the competitive landscape, the domestic market is dominated by generic drugs. At present, nearly 20 enterprises have obtained preparation approvals, and a number of local enterprises have achieved large-scale production on the API supply side, leading to sufficient overall supply. In addition, this variety has been included in the provincial centralized procurement catalogs of multiple provinces, and the winning bid price has dropped by about 70% compared with the original research drug, greatly improving clinical accessibility.

The original research enterprise of ramosetron is Astellas Pharma of Japan, and the original brand name is "Nasea". The expiration date of its core compound patent in Japan is 2007, and the Chinese compound patent also expired in 2007. The main dosage forms approved for the original research drug are injection and orally disintegrating tablet. The specification of the injection is 0.3mg/2ml, and the specification of the orally disintegrating tablet is 0.1mg. Both the original research injection and orally disintegrating tablet have been included in the *Reference Listed Drug Catalog of Chemical Drugs* issued by the National Medical Products Administration. At present, there are more than 30 ramosetron API registration numbers in China, most of which are in the activated state, and the approved preparation varieties cover multiple dosage forms such as injection and orally disintegrating tablet. (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 ramosetron API. Most products are available from stock. Stock orders submitted before 16:00 can be shipped on the same day. All products meet the requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can fully meet the compliance needs of the whole process of API R&D, quality research and registration.