华润双鹤(600062.SH):控股子公司湖南省湘中制药有限公司奥卡西平片获得药品注册证书

Core Viewpoint - China Resources Double Crane (华润双鹤) announced that its subsidiary, Hunan Xiangzhong Pharmaceutical Co., Ltd., received the drug registration certificate for Oxcarbazepine Tablets from the National Medical Products Administration (NMPA) [1] Group 1: Drug Registration and Approval - The drug, Oxcarbazepine Tablets, is indicated for the treatment of primary generalized tonic-clonic seizures and partial seizures in adults and children aged 5 years and older [1] - The research and development of this generic drug began in August 2021, with the application for market authorization submitted on July 26, 2024, and acceptance notification received on August 14, 2024 [1] - The drug is expected to be approved for market launch on November 12, 2025, and the registration certificate is considered equivalent to passing the consistency evaluation according to national policies [1] Group 2: Financial Investment and Market Impact - The total R&D investment for this drug has reached RMB 14.2164 million (approximately 2.1 million USD) as of the announcement date [1] - The approval of the drug registration certificate will enhance the company's product line, improve market competitiveness, and provide valuable experience for future product development [1]