Napipitant‌

For chemotherapy-induced nausea and vomiting (CINV), a common dose-limiting adverse reaction during tumor treatment, the advent of neurokinin-1 (NK-1) receptor antagonists has greatly improved the treatment compliance of patients. Fosaprepitant is a long-acting prodrug of NK-1 receptor antagonist, which can be rapidly converted into the active ingredient aprepitant after entering the body. It highly selectively blocks the binding of substance P and NK-1 receptors in the central nervous system, thereby inhibiting acute and delayed nausea and vomiting induced by chemotherapy. Clinically, it is mainly used in combination with 5-hydroxytryptamine 3 receptor antagonists and dexamethasone to prevent CINV in adult patients receiving highly or moderately emetogenic chemotherapy, and is especially suitable for the tumor treatment population who need to simplify the antiemetic regimen and improve medication compliance.

At present, the global market size of antiemetic drugs has exceeded 2 billion US dollars, among which NK-1 receptor antagonists account for nearly 30%, with a compound annual growth rate of about 6%. In the domestic market, fosaprepitant, with the advantage of long-acting administration, has achieved a market growth rate of 22% in the past 3 years, which is significantly higher than the average level of similar antiemetic drugs. In terms of the competitive landscape, currently only the original drug and generic preparations from 2 domestic enterprises have been approved for marketing, and the supply of API is still in a relatively concentrated stage. With the improvement of the recommendation level of the NK-1 receptor antagonist combination regimen in clinical guidelines, there is still a large room for the release of subsequent market demand.

The original developer of fosaprepitant is Merck Sharp & Dohme, and the original brand name is Emend. The expiration date of its core compound patent in the United States is 2023, and the core patent in China has expired in 2022. The main dosage form approved for the original drug is injection with a specification of 150 mg per vial, which has been included in the FDA Reference Listed Drug Catalog and China's *Catalog of Reference Preparations for Chemical Drugs (6th Batch)*. In terms of domestic API registration, 3 enterprises have obtained CDE registration numbers for fosaprepitant API so far, among which 2 registration statuses are A, which can be used in association with preparation declaration; domestic generic fosaprepitant for injection has been approved for marketing. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of fosaprepitant impurity reference standards, which meet the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA. Most of the products are in sufficient stock, and in-stock products ordered before 16:00 can be shipped on the same day, which can provide stable reference material support for API and preparation enterprises in the links of quality research and registration declaration.