成都苑东生物制药股份有限公司关于自愿披露布瑞哌唑片获得药品注册证书的公告

Group 1 - The company has received the drug registration certificate for Brexpiprazole tablets from the National Medical Products Administration, marking a significant milestone for the product [1][2] - Brexpiprazole tablets are indicated for the treatment of adult schizophrenia and are classified as a Class 4 chemical drug with a shelf life of 12 months [1][2] - The product is the first domestically approved generic drug under the new registration classification, equivalent to passing the consistency evaluation [2][4] Group 2 - Brexpiprazole was originally developed by Otsuka Pharmaceutical Co., Ltd. and was approved for sale in the U.S. in July 2015, with the product expected to be imported into China by June 2024 [2] - Currently, only the original Otsuka product is available in the domestic market, with sales amounting to approximately 160,000 yuan in the first half of 2025 [2] - The approval of Brexpiprazole tablets is not expected to have a significant impact on the company's recent performance, although uncertainties may arise during the production and sales phase [4]