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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
Core Viewpoint - Jinling Pharmaceutical Co., Ltd. has received a drug re-registration approval notice for its Hydrolyzed Protein Injection, which will facilitate the resumption of production and sales of this product [1][3]. Group 1: Drug Registration Details - The drug in question is Hydrolyzed Protein Injection, which is a sterilized solution of hydrolyzed casein and whey protein with sorbitol, primarily used for severe amino acid deficiency due to major surgical trauma, extensive burns, and various diseases causing hypoproteinemia [2]. - The application for re-registration was accepted under the number CYHZ2514512, and the approval was granted by the Fujian Provincial Drug Administration [1]. Group 2: Impact on the Company - The approval for the re-registration of the drug will benefit the company by allowing the resumption of normal production and sales; however, it is not expected to have a significant impact on the company's recent operating performance [3]. - The company is required to conduct subsequent work in strict accordance with regulatory requirements to achieve market sales of the product [3].
7月批准注册医械产品295个;适龄女生可免费接种HPV疫苗 | 健讯Daily
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]
7月批准注册医械产品295个;适龄女生可免费接种HPV疫苗
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]
金陵药业:福州梅峰制药厂的水解蛋白注射液获得药品再注册批准通知书
Ge Long Hui· 2025-08-20 10:19
Core Viewpoint - Jinling Pharmaceutical (000919.SZ) has received a drug re-registration approval notice from the Fujian Provincial Drug Administration for its hydrolyzed protein injection, indicating a positive regulatory development for the company [1] Company Summary - Jinling Pharmaceutical's subsidiary, Fuzhou Meifeng Pharmaceutical Factory, has been granted approval for the hydrolyzed protein injection, which is a sterilized solution of hydrolyzed casein and whey protein with sorbitol [1] - The hydrolyzed protein injection is primarily used for severe amino acid deficiency caused by serious surgical trauma and extensive burns, as well as for hypoproteinemia resulting from various diseases [1]
金陵药业(000919.SZ):福州梅峰制药厂的水解蛋白注射液获得药品再注册批准通知书
Ge Long Hui A P P· 2025-08-20 10:07
Core Viewpoint - Jinling Pharmaceutical (000919.SZ) has received a drug re-registration approval notice for hydrolyzed protein injection from the Fujian Provincial Drug Administration, indicating a significant regulatory milestone for the company [1] Group 1: Company Developments - Jinling Pharmaceutical's subsidiary, Fuzhou Meifeng Pharmaceutical Factory, has been granted approval for hydrolyzed protein injection, which is a sterilized solution of hydrolyzed casein and whey protein with sorbitol [1] - The hydrolyzed protein injection is primarily used for severe amino acid deficiency caused by major surgical trauma, extensive burns, and various diseases leading to hypoproteinemia [1]
金陵药业:福州梅峰制药厂水解蛋白注射液获再注册批准
Xin Lang Cai Jing· 2025-08-20 08:33
Core Viewpoint - Jinling Pharmaceutical's subsidiary, Fuzhou Meifeng Pharmaceutical Factory, has received a re-registration approval notice for hydrolyzed protein injection from the Fujian Provincial Drug Administration, which is expected to facilitate the resumption of production and sales of the drug [1] Group 1: Company Developments - The drug approval notification number is 2025R079210, and the product specification is 500ml:25g (hydrolyzed protein), classified as a chemical drug [1] - The hydrolyzed protein injection is indicated for severe amino acid deficiency and hypoproteinemia [1] - Due to long-term suspension of production, the company must apply for an on-site inspection from the provincial drug administration before resuming production and sales [1] Group 2: Market Impact - The re-registration is beneficial for the drug's production and sales recovery, but it is noted that there will be no significant impact on the company's recent performance [1] - The production and sales of the drug are subject to uncertainties influenced by policies and market factors [1]
金陵药业:分公司收到水解蛋白注射液药品再注册批准通知书
Di Yi Cai Jing· 2025-08-20 08:32
Core Viewpoint - Jinling Pharmaceutical announced that its subsidiary, Fuzhou Meifeng Pharmaceutical Factory, received a drug re-registration approval notice from the Fujian Provincial Drug Administration for hydrolyzed protein injection, which is used for severe amino acid deficiency due to serious surgical trauma and large-area burns, as well as low protein levels caused by various diseases [2] Summary by Relevant Sections - **Product Approval** - The drug hydrolyzed protein injection is aimed at treating severe amino acid deficiency and low protein levels [2] - The approval notice will facilitate the resumption of normal production and sales of the drug [2] - **Production Resumption Requirements** - Due to a long period of non-production, the company must apply for on-site inspections from provincial drug supervision authorities and ensure that three batches of products pass inspection before the drug can be marketed [2] - **Impact on Financial Performance** - The approval is expected to benefit the drug's production and sales but will not have a significant impact on the company's recent operating performance [2]