Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (hereinafter referred to as the "Company") has received the Approval Notice for Chemical Active Pharmaceutical Ingredient (API) Marketing Application for Vilazodone Hydrobromide, issued by the National Medical Products Administration (hereinafter referred to as the "NMPA").
Vilazodone Hydrobromide is mainly used for the treatment of major depressive disorder (MDD) in adults. The Company submitted the marketing application for this active pharmaceutical ingredient (API) to the Center for Drug Evaluation (hereinafter referred to as "CDE") of the National Medical Products Administration in October 2023, and recently obtained the Approval Notice for Chemical API Marketing Application issued by the National Medical Products Administration. The status of this API on the CDE's Registration Information Platform for Excipients, APIs and Packaging Materials is shown as "A". Up to now, the Company has accumulated a total R&D investment of approximately RMB 4.29 million in Vilazodone Hydrobromide. Currently, the main domestic manufacturers of Vilazodone Hydrobromide API include Jiangsu Nhwa Pharmaceutical Co., Ltd. and Jilin Huikang Pharmaceutical Co., Ltd. According to public data, the sales volume of Vilazodone Hydrobromide Tablets in the terminal of China's public medical institutions exceeded RMB 150 million in 2023, with a year-on-year growth of 6.52%.
