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]

证券代码：603707 证券简称：健友股份 公告编号：2025-087 债券代码：113579 债券简称：健友转债 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 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述或者重大遗漏，并对其内容 的真实性、准确性和完整性承担个别及连带责任。 南京健友生化制药股份有限公司（以下简称"健友股份"或"公司"）子公司健进制药有限公司（以下简 称"健进制药"）于近日收到美国食品药品监督管理局（以下简称"美国FDA"）签发的注射用达巴万星， 500 mg/瓶的ANDA批准通知（ANDA号：218929）。现将相关情况公告如下： 一、药品的基本情况 （一）药品名称：注射用达巴万星 二、药品其他相关情况 （二）适 应 症：成人和儿科患者的急性细菌性皮肤和皮肤结构感染。 四、风险提示 公司高度重视药品研发，严格控制药品研发、生产、销售环节的质量和安全。但产品的生产和销售容易 受国家政策、市场环境等不确定因素的影响，有可能存在销售不达预期等情况。敬请广大投资者谨慎决 策，注意防范投资风险。 特此公告。 南京健友生化制药股份有限公司董事 ...

Group 1 - The core viewpoint of the article highlights the approval of a product by a subsidiary of Jianyou Co., Ltd. from the FDA, which is a significant milestone for the company [1][2]. - The article mentions that the Jin 23 convertible bond will not undergo any adjustments, indicating stability in its terms [2]. - The article provides a detailed table of various convertible bonds, including their current prices, redemption prices, last trading dates, and conversion values, which are essential for investors to assess their investment options [4][6]. Group 2 - Jianyou Co., Ltd.'s subsidiary has received FDA approval for its injectable product, Daba Wanxing, which could enhance the company's market position and growth potential [1]. - The article lists several convertible bonds with their respective financial metrics, such as the current price of 110.499 for Hengbang Convertible Bond and a conversion value of 110.63, which reflects the bond's performance [4]. - The convertible bond market is highlighted with various bonds showing different metrics, such as the Z Qibin Convertible Bond with a current price of 109.529 and a conversion value of 109.95, indicating the diverse investment opportunities available [4][6].

健友股份（603707）(603707.SH)发布公告，公司子公司健进制药有限公司(简称"健进制药")于近日收到 美国食品药品监督管理局(简称"美国FDA")签发的注射用达巴万星，500mg/瓶的ANDA批准通知(ANDA 号：218929)。该适应症：成人和儿科患者的急性细菌性皮肤和皮肤结构感染。 ...

人民财讯11月27日电，健友股份（603707）11月27日公告，子公司健进制药有限公司于近日收到美国食 品药品监督管理局(简称"美国FDA")签发的注射用达巴万星，500mg/瓶的ANDA批准通知。该药品适应 症为成人和儿科患者的急性细菌性皮肤和皮肤结构感染。新批准产品近期将安排在美国上市销售，有望 对公司经营业绩产生积极影响。 ...

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]