登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：000919 证券简称：金陵药业 公告编号：2025-057 金陵药业股份有限公司关于分公司收到 药品再注册批准通知书的公告 一、申请注册药品的基本情况 受理号：CYHZ2514512闽 药品名称：水解蛋白注射液 申请事项：境内生产药品再注册 许可药品注册分类：化学药品 规格：500ml:25g(水解蛋白) 上市许可持有人：金陵药业股份有限公司福州梅峰制药厂 审批结论：经审查，同意本品再注册。由于本品长期未生产，恢复生产时，须向省级药品监督管理部门 提出现场检查申请，经现场检查合格且抽取三批产品检验合格后，方可上市销售。 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假记载、误导性陈述或重大遗 漏。 金陵药业股份有限公司（以下简称"公司"）分公司金陵药业股份有限公司福州梅峰制药厂于近日收到福 建省药品监督管理局下发的药品再注册批准通知书（2025R079210），现将相关情况公告如下： 水解蛋白注射液为水解物酪蛋白和乳蛋白与山梨醇的灭菌溶液，主要用于手术严重创伤、大面积烧伤引 起的严重氨基酸缺乏，以及各种疾病引起的低蛋白血症。 三、 ...

Policy Developments - The National Healthcare Security Administration issued the "Guidelines for the Project Establishment of Physical Therapy Medical Service Price (Trial)" which integrates existing price projects into 32 items, with 7 additional charges and 1 expansion item [2] Medical Device Approvals - In July, the National Medical Products Administration approved the registration of 295 medical device products, including 240 domestic Class III medical devices, 21 imported Class III medical devices, 29 imported Class II medical devices, and 5 products from Hong Kong, Macau, and Taiwan [4] Company Announcements - New Industries announced that 18 of its chemiluminescent reagent products received IVDR CE certification, allowing them to enter the EU market, which is expected to enhance the company's competitive edge [5] - Jimin Health reported a net loss of 52.7 million yuan for the first half of 2025, with revenue of 366 million yuan, a year-on-year decrease of 21.3% [9] - Zhongyao Holdings disclosed a net profit of 282 million yuan for the first half of 2025, with revenue of 41.188 billion yuan, reflecting a year-on-year growth of 3.54% [8] - Jinling Pharmaceutical received a drug re-registration approval for hydrolyzed protein injection, which is used for severe amino acid deficiency due to major surgeries and other diseases [6] - Chenguang Biological announced plans to transfer 97.5% of its subsidiary Chenguang Tianrun Pharmaceutical to Sichuan Tongsheng Biological Medicine, with the transfer based on the subsidiary's book equity as of July 31, 2025 [11] - Baiyang Pharmaceutical's controlling shareholder plans to increase capital and change the equity structure, with a new entity set to acquire 80% of the controlling group [12] Industry Events - A groundbreaking cervical spine surgery was successfully performed in Shanghai, utilizing innovative "satellite plate" technology to stabilize a severely injured patient's spine [14] - Guangxi plans to provide free HPV vaccinations to nearly 960,000 eligible girls from 2025 to 2027, emphasizing the importance of preventive healthcare [15] Shareholder Actions - Multiple shareholders of Sanxin Medical plan to reduce their holdings due to personal financial needs, with specific share amounts outlined for each individual [17]

Policy Developments - The National Healthcare Security Administration issued the "Guidelines for the Establishment of Pricing Projects for Physical Therapy Medical Services (Trial)" which integrates existing pricing projects into 32 items, with 7 additional charges and 1 expansion item [2] Medical Device Approvals - In July, the National Medical Products Administration approved 295 medical device products, including 240 domestic Class III devices, 21 imported Class III devices, 29 imported Class II devices, and 5 devices from Hong Kong, Macau, and Taiwan [4] Company Announcements - New Industries announced that 18 of its chemiluminescent reagent products received IVDR CE certification, allowing them to enter the EU market, which is expected to enhance the company's competitiveness [5] - Jining Pharmaceutical received a drug re-registration approval for hydrolyzed protein injection, which is used for severe amino acid deficiency and will help restore normal production and sales [6] - Chongqing Pharmaceutical Holdings reported a net profit of 282 million yuan for the first half of the year, with a revenue of 41.188 billion yuan, marking a 3.54% year-on-year increase [8] - Jimin Health reported a net loss of 52.6959 million yuan for the first half of 2025, with a revenue of 36.6 million yuan, down 21.30% year-on-year [9] - Chenguang Bio announced plans to transfer 97.5% of its subsidiary Chenguang Tianrun Pharmaceutical to Sichuan Tongsheng Biomedical, with the transfer based on the subsidiary's equity as of July 31, 2025 [11] - Baiyang Pharmaceutical's controlling shareholder plans to increase capital and change the shareholding structure, with a new entity set to acquire 80% of the controlling group [13] Industry Events - A groundbreaking cervical spine surgery was successfully performed in Shanghai, utilizing innovative "satellite steel plate" technology to stabilize a severely injured patient's spine [15] - Guangxi plans to provide free HPV vaccinations to nearly 960,000 eligible girls from 2025 to 2027, emphasizing the importance of preventive healthcare [16] Shareholder Actions - Multiple shareholders of Sanxin Medical plan to reduce their stakes in the company due to personal financial needs, with specific share amounts outlined for each individual [18]

格隆汇8月20日丨金陵药业(000919.SZ)公布，公司分公司金陵药业股份有限公司福州梅峰制药厂于近日 收到福建省药品监督管理局下发的水解蛋白注射液的药品再注册批准通知书(2025R079210)。水解蛋白 注射液为水解物酪蛋白和乳蛋白与山梨醇的灭菌溶液，主要用于手术严重创伤、大面积烧伤引起的严重 氨基酸缺乏，以及各种疾病引起的低蛋白血症。 ...

格隆汇8月20日丨金陵药业(000919.SZ)公布，公司分公司金陵药业股份有限公司福州梅峰制药厂于近日 收到福建省药品监督管理局下发的水解蛋白注射液的药品再注册批准通知书(2025R079210)。水解蛋白 注射液为水解物酪蛋白和乳蛋白与山梨醇的灭菌溶液，主要用于手术严重创伤、大面积烧伤引起的严重 氨基酸缺乏，以及各种疾病引起的低蛋白血症。 ...

2025年8月20日金陵药业公告，其分公司福州梅峰制药厂近日收到福建省药监局下发的水解蛋白注射液 药品再注册批准通知书（2025R079210）。该药品受理号为CYHZ2514512闽，规格为500ml:25g(水解蛋 白)，属化学药品。因长期未生产，恢复生产需向省级药监局提现场检查申请，检查及抽检合格方可上 市。水解蛋白注射液用于严重氨基酸缺乏及低蛋白血症。获再注册利于药品恢复产销，但对近期业绩无 重大影响，且药品产销受政策、市场等因素影响有不确定性，提醒投资者注意风险。 ...

金陵药业公告称，公司分公司金陵药业股份有限公司福州梅峰制药厂近日收到福建省药品监督管理局下 发的药品再注册批准通知书。该药品为水解蛋白注射液，主要用于手术严重创伤、大面积烧伤引起的严 重氨基酸缺乏，以及各种疾病引起的低蛋白血症。由于长期未生产，恢复生产时需向省级药品监督管理 部门提出现场检查申请，并经抽取三批产品检验合格后，方可上市销售。该批准通知书将有利于上述药 品恢复正常生产和销售，但不会对公司近期经营业绩产生重大影响。 （文章来源：第一财经） ...