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 - Hekang New Energy's subsidiary received a government subsidy of 6 million yuan, accounting for 58.27% of the company's latest audited net profit attributable to shareholders [1] - Anhui Construction won two major EPC projects with a total bid price of 2.603 billion yuan [2] - Tianrun Dairy's wholly-owned subsidiary received a government subsidy of 7.9094 million yuan, representing 18.12% of the company's audited net profit for 2024 [2] Group 2 - Yunnan Gold's subsidiary obtained a mining license for the Xinxiao County Tanxi Tungsten Mine, with a production capacity of 990,000 tons per year [5][22] - Yanzhou Coal Energy plans to acquire 100% equity of a high-end support company for 345 million yuan [6] - Heng Rui Pharmaceutical received approval for multiple drug clinical trials, including Sulfate Amexitin tablets [8] Group 3 - Huazhi Jie plans to invest 157 million yuan to establish five wholly-owned subsidiaries to expand its global strategy [1] - Junting Hotel's controlling shareholder is planning a change of control, leading to a continued suspension of trading [4] - Funi Technology's shareholder plans to reduce its stake by up to 1.68% [10] Group 4 - Midea Group's subsidiary received a government subsidy of 6 million yuan, which is 58.27% of the company's latest audited net profit [1] - Hunan Gold's subsidiary obtained a mining license for tungsten, iron, and silver, with a production scale of 990,000 tons per year [5][22] - Xin Hua Pharmaceutical received approval for the listing application of Acetate Prednisone raw material [24][25] Group 5 - Zhejiang Pharmaceutical plans to spin off its subsidiary for a listing on the Hong Kong Stock Exchange [28] - Kesheng Technology plans to invest 61.2 million yuan to acquire 51% of Shenzhen Guanding [30] - Tian Shan Aluminum's 1.4 million tons electrolytic aluminum green low-carbon energy efficiency improvement project has commenced production [38]

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。 ...

| 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）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。 二、药品其他相关情况 公司于 2025 年 11 月 27 日收到美国 FDA 的通知，公司子公司健进制药向美 国 FDA 申报的注射用达巴万星，500 mg/瓶的 ANDA 申请获得批准。 注射用达巴 ...

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]

格隆汇11月25日丨健友股份(603707.SH)在投资者互动平台表示，公司没有用于流感治疗的药物或在研 药物。 ...

Group 1 - The company, Jianyou Co., Ltd. (603707.SH), stated on the investor interaction platform that it does not have any drugs for the treatment of influenza or any drugs under research for this purpose [1]

格隆汇11月25日丨健友股份(603707.SH)在投资者互动平台表示，公司没有用于流感治疗的药物或在研 药物。 ...