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].

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]

Core Viewpoint - The company announced that its subsidiary, Jianjin Pharmaceutical Co., Ltd., received ANDA approval from the U.S. FDA for its injectable Dapavansine, 500mg/vial, for treating acute bacterial skin and skin structure infections in adults and pediatric patients [1] Group 1 - The ANDA number for the approved product is 218929 [1] - The approval expands the company's product offerings in the U.S. market [1] - The indication covers both adult and pediatric patients, indicating a broad potential market [1]

| 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 ...

Core Viewpoint - The company Jianyou Co., Ltd. has received ANDA approval from the U.S. FDA for its injectable drug Dapavansheng, which is indicated for acute bacterial skin and skin structure infections in both adult and pediatric patients [1] Group 1 - The approved product is a 500mg per bottle formulation [1] - The product is expected to be launched in the U.S. market soon [1] - The approval is anticipated to have a positive impact on the company's operating performance [1]

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]

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]

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]

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]