NKF(SH:603707) Zhong Guo Zheng Quan Bao - Zhong Zheng Wang·2025-11-28 00:33Core 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]