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华北制药股份有限公司关于下属公司获得《药品注册证书》的公告
Shang Hai Zheng Quan Bao· 2026-02-09 19:19
Core Viewpoint - North China Pharmaceutical Co., Ltd. has announced that its wholly-owned subsidiary, Hebei Huamin Pharmaceutical Co., Ltd., has received the Drug Registration Certificate for Cefprozil Tablets (0.25g) from the National Medical Products Administration, which is expected to enhance the company's product portfolio and market competitiveness [1][6]. Group 1: Drug Registration Details - The Drug Registration Certificate for Cefprozil Tablets (0.25g) was approved by the National Medical Products Administration [1]. - Cefprozil is a second-generation cephalosporin antibiotic, initially developed by Bristol-Myers Squibb in 1991, and was the first oral cephalosporin approved by the FDA for treating pediatric otitis media and sinusitis [1][2]. Group 2: Indications and Market Situation - The approved indications for Cefprozil in China include treatment for upper respiratory infections, lower respiratory infections, and skin and soft tissue infections caused by sensitive bacteria [2]. - Currently, there are 10 companies, including Huamin, that hold the Drug Registration Certificate for Cefprozil Tablets (0.25g) in China. Sales figures for Cefprozil Tablets in sample hospitals from 2023 to the first three quarters of 2025 are reported as 141.7 million, 134.99 million, and 74.22 million yuan respectively [5]. Group 3: Research and Development Investment - The cumulative R&D investment for the drug has reached 14.6458 million yuan (unaudited) [3]. Group 4: Future Prospects - Following the receipt of the Drug Registration Certificate, the company can arrange for production and market the product [4].
华北制药获得头孢丙烯片药品注册证书
Bei Jing Shang Bao· 2026-02-09 11:47
Core Viewpoint - North China Pharmaceutical (华北制药) announced that its wholly-owned subsidiary, Hebei Huamin Pharmaceutical Co., Ltd., received the drug registration certificate for Cefprozil Tablets (0.25g) from the National Medical Products Administration [1] Group 1: Company Information - The drug Cefprozil is a second-generation cephalosporin antibiotic, first developed by Bristol-Myers Squibb in 1991 [1] - Cefprozil is the first oral cephalosporin approved by the FDA for treating pediatric otitis media and sinusitis [1] - The drug was approved for market entry in China by the National Medical Products Administration in 1999 [1] Group 2: Product Details - The approved indication for Cefprozil in China is for the treatment of mild to moderate infections caused by sensitive bacteria [1]
华北制药(600812.SH):下属公司头孢丙烯片获得《药品注册证书》
Ge Long Hui A P P· 2026-02-09 09:20
Core Viewpoint - North China Pharmaceutical (600812.SH) announced that its wholly-owned subsidiary, Hebei Huamin Pharmaceutical Co., has received the drug registration certificate for Cefprozil tablets (0.25g) from the National Medical Products Administration, marking a significant development in its antibiotic portfolio [1] Group 1: Product Approval - The drug Cefprozil is classified as a second-generation cephalosporin antibiotic [1] - The approved indications for Cefprozil in China include treatment for mild to moderate infections caused by sensitive bacteria, such as upper respiratory infections, lower respiratory infections, and skin and soft tissue infections [1] Group 2: Indications - Specific approved indications include: 1. Upper respiratory infections: Streptococcal pharyngitis/tonsillitis, otitis media, and acute sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis [1] 2. Lower respiratory infections: Acute bronchitis and exacerbations of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis [1] 3. Skin and soft tissue infections: Non-complicated infections caused by Staphylococcus aureus and Streptococcus pyogenes, with the note that abscesses may require surgical drainage [1]
华北制药:下属公司头孢丙烯片获得《药品注册证书》
Ge Long Hui· 2026-02-09 09:16
Core Viewpoint - North China Pharmaceutical (600812.SH) announced that its wholly-owned subsidiary, Hebei Huamin Pharmaceutical Co., has received the drug registration certificate for Cefprozil tablets (0.25g) from the National Medical Products Administration, indicating a significant regulatory approval for a new antibiotic product [1] Group 1: Product Approval - The drug Cefprozil is classified as a second-generation cephalosporin antibiotic [1] - The approved indications for Cefprozil in China include treatment for mild to moderate infections caused by sensitive bacteria, such as upper respiratory infections, lower respiratory infections, and skin and soft tissue infections [1] Group 2: Indications - For upper respiratory infections, Cefprozil is indicated for conditions like streptococcal pharyngitis/tonsillitis and acute otitis media caused by Streptococcus pneumoniae and Haemophilus influenzae [1] - In lower respiratory infections, it is used for acute bronchitis secondary to bacterial infections and acute exacerbations of chronic bronchitis [1] - The drug is also indicated for non-complicated skin and soft tissue infections caused by Staphylococcus aureus and streptococci, although abscesses typically require surgical drainage [1]
华北制药(600812) - 关于下属公司获得《药品注册证书》的公告
2026-02-09 09:15
证券代码:600812 股票简称:华北制药 编号:临 2026-006 华北制药股份有限公司 关于下属公司获得《药品注册证书》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。 近日,华北制药股份有限公司(以下简称"公司")全资子公司华北 制药河北华民药业有限责任公司(以下简称"华民公司")收到国家药品 监督管理局核准签发的头孢丙烯片(0.25g)的《药品注册证书》,现将有 关情况公告如下: 头孢丙烯(Cefprozil)属于第二代头孢菌素抗生素,该产品于 1991 年由 美国 Bristol-Myers Squibb Company 首先研制成功,商品名为施复捷,是美 国 FDA 批准的第一个可用于治疗儿童中耳炎和鼻窦炎的口服头孢菌素类 抗生素,1999 年获得中国国家药品监督管理局批准中国上市。 本品国内批准的适应症为用于敏感菌所致的下列轻、中度感染:1.上 呼吸道感染(1)化脓性链球菌性咽炎/扁桃体炎。(2)肺炎链球菌、流感 嗜血杆菌(包括产β-内酰胺酶菌株)和卡他莫拉菌(包括产β-内酰胺酶 菌株)性中耳炎及急性鼻窦 ...
华北制药:子公司头孢丙烯片获得药品注册证书
Xin Lang Cai Jing· 2026-02-09 09:12
Core Viewpoint - Huabei Pharmaceutical's subsidiary Huamin Company has received approval from the National Medical Products Administration for the registration of Cefprozil Tablets (0.25g), a second-generation cephalosporin antibiotic used for mild to moderate infections caused by sensitive bacteria [1] Group 1 - The registration certificate for Cefprozil Tablets was obtained on February 9, 2026, after the application was submitted in October 2024 [1] - The total research and development investment for this product amounted to 14.6458 million yuan [1]
华北制药:全资子公司华民公司收到国家药品监督管理局核准签发的头孢丙烯片(0.25g)的《药品注册证书》
Guo Ji Jin Rong Bao· 2026-02-09 09:08
Core Viewpoint - Huabei Pharmaceutical's subsidiary, Huamin Company, has received approval from the National Medical Products Administration for the registration of Cefprozil Tablets (0.25g), a second-generation cephalosporin antibiotic used for treating mild to moderate infections caused by sensitive bacteria [1] Group 1: Product Development - Huamin Company submitted the application for Cefprozil Tablets in October 2024 and received the acceptance number, followed by obtaining the registration certificate in February 2026 [1] - The total R&D investment for the product amounts to 14.6458 million yuan [1] Group 2: Market Context - Currently, there are 10 companies in China holding the registration certificate for Cefprozil Tablets [1] - The projected sales revenue for Cefprozil Tablets in sample hospitals in China is estimated to be 142 million yuan in 2023, 135 million yuan in 2024, and 74.22 million yuan in 2025 [1]
华北制药股份有限公司 关于为下属子公司提供担保的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2026-02-02 23:00
Core Viewpoint - The company has provided a guarantee of 140 million yuan for its subsidiary, Huamin Company, to support its working capital loan from Bank of Communications Hebei Branch, bringing the total guarantee amount to 683 million yuan as of the announcement date [1][2]. Group 1: Guarantee Details - The guarantee provided to Huamin Company is within the total limit approved at the 2024 annual shareholders' meeting and does not require further board or shareholder approval [2]. - The company has approved a total guarantee limit of 3.095 billion yuan for subsidiaries and external parties, with a specific limit of 765 million yuan for Huamin Company [1][4]. Group 2: Financial Health of Huamin Company - As of September 30, 2025, Huamin Company's debt-to-asset ratio stands at 51.03%, indicating a moderate level of financial leverage [2]. Group 3: Board's Opinion - The board believes that providing guarantees for subsidiaries is essential for their operational and strategic needs, contributing to their stable operation and long-term development [4]. Group 4: Cumulative Guarantee Situation - As of the announcement date, the total external guarantees provided by the company and its subsidiaries amount to approximately 1.644 billion yuan, which is 30.50% of the audited net assets attributable to ordinary shareholders for the year 2024 [5].
华北制药为子公司华民公司提供1.4亿元担保
Bei Jing Shang Bao· 2026-02-02 10:57
Core Viewpoint - North China Pharmaceutical announced a guarantee contract with Bank of Communications Hebei Branch to support its subsidiary, Huamin Company, with a guarantee amount of 140 million yuan [1] Group 1: Guarantee Details - The guarantee provided by North China Pharmaceutical is aimed at meeting the production and operational needs of Huamin Company, facilitating its stable operation and long-term development [1] - The total guarantee amount provided by North China Pharmaceutical to Huamin Company, including this new guarantee, is 683 million yuan [1] Group 2: Financial Metrics - As of September 30, 2025, Huamin Company's debt-to-asset ratio stands at 51.03% [1] - The guarantee is within the total limit expected to be reviewed at North China Pharmaceutical's 2024 annual shareholders' meeting and is within the guarantee amount previously provided to Huamin Company [1]
华北制药:公司为控股子公司提供担保总额约15.54亿元
Mei Ri Jing Ji Xin Wen· 2026-02-02 10:02
Group 1 - The company Huabei Pharmaceutical announced that as of the disclosure date, the total amount of external guarantees provided by the company and its controlling subsidiaries is approximately 1.644 billion yuan, accounting for 30.5% of the audited net assets attributable to ordinary shareholders for the year 2024 [1] - Among the total guarantees, the company provided guarantees totaling approximately 1.554 billion yuan for its controlling subsidiaries, which represents 28.83% of the audited net assets attributable to ordinary shareholders for 2024 [1] - The amount of guarantees provided to external units not included in the consolidated financial statements is 90 million yuan, accounting for 1.67% of the audited net assets attributable to ordinary shareholders for 2024 [1] Group 2 - The automotive sales giant Baolide, known for selling luxury cars such as Rolls-Royce and Porsche, is currently undergoing bankruptcy liquidation, with its headquarters in Hangzhou now vacant and its subsidiary in Yiwu sealed [1]