Netupitant

Chemotherapy-induced nausea and vomiting (CINV) is one of the most common adverse reactions in tumor patients during chemotherapy, with an incidence rate as high as over 70%, which seriously affects patients' treatment compliance and quality of life. Netupitant is a long-acting NK-1 receptor antagonist. It blocks the emetic effect of substance P by highly selectively binding to human neurokinin-1 receptor, and has a half-life of up to 90 hours. Only a single administration is required to cover the whole-process prevention and control of acute and delayed CINV after chemotherapy. It is often formulated into a fixed-dose combination product with palonosetron in clinical practice for the prevention of nausea and vomiting caused by highly and moderately emetogenic chemotherapy regimens, and the applicable population covers adult patients receiving chemotherapy for solid tumors and hematological tumors.

The global netupitant market size was approximately USD 1.42 billion in 2023, and is expected to grow steadily at a compound annual growth rate of 4.8% from 2024 to 2030. The growth drivers mainly include the rising global tumor incidence, the popularization of chemotherapy regimens and the increasing clinical attention to the whole-process management of CINV. In terms of competitive landscape, the original research product still accounts for about 62% of the global market share. In the Chinese market, with the successive launch of generic drugs after patent expiration, the price of the original research product has dropped by about 45%. At present, 6 domestic enterprises have submitted marketing applications for generic drugs, and centralized procurement is expected to further promote the increase of product penetration.

The original research enterprise of netupitant is Helsinn, a Swiss pharmaceutical company, and the original trade name is Akynzeo (Aokangze, a fixed-dose combination of netupitant and palonosetron), whose Chinese compound patent will expire in 2025. The main marketed dosage form of the original research product is hard capsule, each capsule contains 300mg of netupitant and 0.5mg of palonosetron hydrochloride. This combination product has been included in the *Catalogue of Reference Preparations for Chemical Drugs (4th Batch)* of China, and is also included in the FDA Reference Preparations List. Up to now, no enterprise in China has obtained the marketing approval of netupitant active pharmaceutical ingredient (API), and there is no valid registration number with A status on the CDE API registration platform for the time being. The only preparation approved for marketing in China is the originally researched imported Akynzeo capsules. (Data as of April 2025, please refer to the official website of CDE for the latest information)

CATO can provide a full set of netupitant impurity reference standards, covering the needs of the whole research path including starting materials, intermediates, degradation impurities, etc. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All products comply with the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully support enterprises' whole-process work of API R&D, quality research and registration declaration.