Asenapine

Schizophrenia and bipolar disorder are high-prevalence severe mental illnesses, and their clinical practice has long been plagued by the pain points of poor medication adherence and adverse reactions that restrict clinical application. Asenapine is a second-generation atypical antipsychotic drug. Through high-affinity antagonism against dopamine D2 receptors and 5-hydroxytryptamine 2A receptors, combined with norepinephrine reuptake inhibitory activity, it can simultaneously improve the positive symptoms, negative symptoms and affective symptoms of mental illnesses. It is clinically mainly used for the acute and maintenance treatment of schizophrenia in adults, as well as the treatment of manic or mixed episodes of type I bipolar disorder in adults, and is particularly suitable for patients with poor tolerance to traditional antipsychotic drugs.

At present, the global antipsychotic drug market size is growing steadily, and the compound annual growth rate of the asenapine market segment in the recent 3 years is approximately 4.2%. As the original research patents expire successively, the substitution space for generic drugs continues to be released. Currently, the domestic market is still in the introduction period, with only a small number of enterprises arranging the generic R&D of this variety, which has not yet been included in the centralized procurement catalogue. The supporting capacity of the API supply side is the core factor for enterprises to quickly seize the market.

The original research manufacturer of asenapine is Organon LLC, and the original research trade name is Saphris. Its core compound patent in the United States expired in 2020, and the core patent in China expired in 2021. The main dosage form approved for the original research product is sublingual tablet, with specifications including 5mg and 10mg. This variety has been included in the FDA Reference Listed Drug Catalogue, and is also included in the *Catalogue of Reference Preparations for Chemical Drugs* of China. Up to now, there is no approved A-status registration number of asenapine API on the CDE API registration platform. A small number of domestic enterprises have submitted clinical applications for asenapine sublingual tablets, and no domestic preparation has been approved for marketing yet. (Data as of December 2024, please refer to the official CDE website for the latest information)

In response to the R&D and quality control needs of this variety, CATO can provide a full set of asenapine impurity reference standards. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and can fully support enterprises in the whole process of API and preparation R&D, quality research, registration and declaration, etc.