Core Points - The company, Nanjing Jianyou Biochemical Pharmaceutical Co., Ltd., announced that its subsidiary, Jianjin Pharmaceutical Co., Ltd., received ANDA approval from the U.S. FDA for injectable Dapavans, 500 mg/bottle [1][2] - The approved drug is indicated for the treatment of acute bacterial skin and skin structure infections in adult and pediatric patients [2] - The reference product for the approved generic is held by AbbVie Inc., which was approved by the U.S. FDA on May 23, 2014, under the brand name DALVANCE [2] - Currently, two other companies, Teva Pharmaceuticals Inc. and Fresenius Kabi USA LLC, have also received approval for their generic versions of injectable Dapavans in the U.S. [2] - The company has invested approximately RMB 18.53 million in the research and development of the injectable Dapavans project [3] - The newly approved product is expected to be launched in the U.S. soon, which is anticipated to have a positive impact on the company's operating performance [4]

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].

Core Viewpoint - The company announced that its subsidiary, Jianjin Pharmaceutical Co., Ltd., received ANDA approval from the FDA for injectable Dalbavancin, which is expected to positively impact the company's financial performance [1] Group 1: Regulatory Approval - Jianjin Pharmaceutical received ANDA approval for injectable Dalbavancin, 500 mg/vial, on November 27, 2025 [1] - The reference formulation for injectable Dalbavancin is held by AbbVie Inc., which was approved by the FDA on May 23, 2014, under the brand name DALVANCE [1] Group 2: Market Competition - Currently, there are two other companies, Teva Pharmaceuticals Inc. and Fresenius Kabi USA LLC, that have also received approval for injectable Dalbavancin generics in the U.S. [1] Group 3: Investment and Financial Impact - The company has invested approximately RMB 18.53 million in research and development for this project [1] - The newly approved product is expected to be launched in the U.S. soon, which is anticipated to have a positive effect on the company's operating performance [1]