NKF(SH:603707) Xin Lang Cai Jing·2025-11-27 08:22Core 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]