Core Viewpoint - The company, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd., announced that its subsidiary, Jianjin Pharmaceutical Co., Ltd., received FDA approval for its injectable drug Dapavansin, which is expected to positively impact the company's financial performance [1][3]. Group 1: Product Information - The drug name is Dapavansin for injection, with a dosage of 500 mg per bottle [2][6]. - It is indicated for the treatment of acute bacterial skin and skin structure infections in both adult and pediatric patients [1][6]. - The reference product for Dapavansin is held by AbbVie Inc., which was approved by the FDA on May 23, 2014, under the brand name DALVANCE [2]. Group 2: Financial and Development Impact - The company has invested approximately RMB 18.53 million in the research and development of Dapavansin to date [3]. - The newly approved product is expected to be launched in the U.S. market soon, which may have a positive effect on the company's operating performance [3].
南京健友生化制药股份有限公司关于子公司产品注射用达巴万星获得美国FDA批准的公告