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健友股份:丙泊酚乳状注射液获得美国FDA批准
Mei Ri Jing Ji Xin Wen· 2025-12-03 08:41
Core Viewpoint - The company, Jianyou Co., Ltd. (603707.SH), has received ANDA approval from the US FDA for its propofol emulsion injection, which is expected to positively impact its operational performance [2]. Group 1: Product Approval - The US FDA has granted ANDA approval for propofol emulsion injection in three specifications: 200 mg/20 mL, 500 mg/50 mL, and 1,000 mg/100 mL [2]. - The reference product is held by FRESENIUS KABI USA LLC [2]. Group 2: Financial Investment - The company has invested approximately RMB 73.66 million in research and development for this product [2]. Group 3: Market Impact - The newly approved product is set to be launched in the US market soon, which is anticipated to have a positive effect on the company's business performance [2].
健友股份(603707) - 健友股份关于股份回购进展的公告
2025-12-02 08:32
| | | 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 关于股份回购进展的公告 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法律责任。 二、回购股份的进展情况 根据《上市公司股份回购规则》《上海证券交易所上市公司自律监管指引第 7 号——回购股份》等相关规定,公司在回购期间,应于每个月的前 3 个交易日内 披露截至上月末的回购进展情况。现将公司回购股份进展情况公告如下: 截至 2025 年 11 月 30 日,公司通过上海证券交易所交易系统以集中竞价交易 方式已累计回购股份137.9995万股,已累计回购股份占公司总股本的比例为0.09%, 成交最低价为 9.56 元/股,成交最高价为 11.66 元/股,支付的总金额为人民币 1500.85 万元(不含交易费用及印花税)。 上述回购股份符合法律法规及公司回购股份方案的规定。 重要内容提示: | 回购方案首次披露日 | 2025/4/29,由董事长唐咏群先生提议 | | | | | | | | --- | --- | --- | --- | --- | - ...
健友股份:已累计回购1500.85万元股份
Ge Long Hui· 2025-12-02 08:15
Group 1 - The company, Jianyou Co., Ltd. (603707.SH), has announced a share buyback program, having repurchased a total of 1.379995 million shares as of November 30, 2025 [1] - The repurchased shares account for 0.09% of the company's total share capital [1] - The lowest transaction price during the buyback was 9.56 CNY per share, while the highest was 11.66 CNY per share, with a total expenditure of 15.0085 million CNY (excluding transaction fees and stamp duty) [1]
健友股份:累计斥资1500.85万元回购0.09%股份
Xin Lang Cai Jing· 2025-12-02 08:08
Core Viewpoint - The company announced a share repurchase plan aimed at supporting employee stock ownership and equity incentives, with a budget of 20 million to 40 million yuan [1] Group 1 - The board of directors approved the share repurchase plan on April 28, 2025, with an implementation period from May 20, 2025, to May 19, 2026 [1] - As of November 30, 2025, the company has repurchased a total of 1.379995 million shares, representing 0.09% of the total share capital [1] - The total amount spent on the repurchase so far is 15.0085 million yuan, with transaction prices ranging from 9.56 yuan to 11.66 yuan per share [1]
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
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]
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
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].
11月27日晚间重要公告一览
Xi Niu Cai Jing· 2025-11-27 10:37
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]
健友股份子公司产品注射用达巴万星获得美国FDA批准
Zhi Tong Cai Jing· 2025-11-27 08:36
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]
健友股份(603707) - 健友股份关于子公司产品注射用达巴万星获得美国FDA批准的公告
2025-11-27 08:30
| 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 ...
健友股份:注射用达巴万星获美国FDA批准
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]