上海现代制药股份有限公司关于全资孙公司获得化学原料药上市申请批准通知书的公告

Core Viewpoint - Shanghai Modern Pharmaceutical Co., Ltd.'s wholly-owned subsidiary, Jiangsu Weiqida Pharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the marketing application of the chemical raw material drug Agomelatine, indicating compliance with national drug approval standards and allowing for domestic production and sales [1][3]. Group 1: Drug Information - The chemical raw material drug is Agomelatine, with registration number Y20240000572 and packaging specifications of 20kg per barrel [1]. - Agomelatine acts on melatonin receptors MT1 and MT2 and antagonizes 5-HT2C to restore disrupted biological rhythms, primarily used for treating major depressive disorder in adults [2]. - As of 2023, the global consumption of Agomelatine raw material is reported to be 5,735.23 kg [2]. Group 2: Company Impact - The approval of Agomelatine for domestic production will enhance the company's specialty raw material drug portfolio and positively influence future development [3]. - The impact on the company's current operating performance is not expected to be significant [3].