华北制药股份有限公司 关于公司获得《药品注册证书》的公告 证券代码：600812 股票简称：华北制药 编号：临 2025-043 二、药物研究的其他相关情况 腺苷钴胺在 1958 年由美国科学家贝克等人发现，我国的腺苷钴胺于 20 世纪 70 年代研制开发，目前国内的制剂形式包括腺苷钴胺片剂、胶囊 剂、注射用腺苷钴胺冻干粉针剂等。 本品可抑制神经髓鞘异常脂肪合成，阻断神经纤维脱髓鞘的发生和发 展；促进蛋白质、类脂合成，修复受损神经；降低异常 TNFα水平，抑制 SACD 发生、参与三羧酸循环，促进三大物质代谢，维护细胞正常功能； 使谷光甘肽含量正常化，保护神经细胞；参与血红素合成，改善贫血。腺 苷钴胺主要用于维生素 B12 缺乏症的防治，维生素 B12 需求量增加而从饮 食中摄取不足时的补充（消耗性疾病、甲亢、孕妇、哺乳期妇女等），巨 幼红细胞性贫血等。 公司腺苷钴胺胶囊（0.5mg）于 2024 年 4 月申报国家药品监督管理局 药品审评中心并取得药品注册受理号，于 2025 年 7 月获得国家药品监督管 理局核准签发的《药品注册证书》。本品视为通过仿制药质量和疗效一致 性评价。 截至目前，累计研发投入：1 ...

华北制药(600812.SH)发布公告，近日，公司收到国家药品监督管理局核准签发的腺苷钴胺胶囊(0.5mg) 的《药品注册证书》。 本品可抑制神经髓鞘异常脂肪合成，阻断神经纤维脱髓鞘的发生和发展;促进蛋白质、类脂合成，修复 受损神经;降低异常TNFα水平，抑制SACD发生、参与三羧酸循环，促进三大物质代谢，维护细胞正常 功能;使谷光甘肽含量正常化，保护神经细胞;参与血红素合成，改善贫血。腺苷钴胺主要用于维生素 B12缺乏症的防治，维生素B12需求量增加而从饮食中摄取不足时的补充(消耗性疾病、甲亢、孕妇、哺 乳期妇女等)，巨幼红细胞性贫血等。 ...

Core Insights - North China Pharmaceutical (600812.SH) has received the drug registration certificate for Adenosylcobalamin capsules (0.5mg) from the National Medical Products Administration, indicating the product's compliance with basic procurement bidding conditions and its efficacy equivalent to the original product [2] Company Summary - The newly approved product is primarily used for the prevention and treatment of vitamin B12 deficiency, which is increasingly needed when dietary intake is insufficient, as well as for megaloblastic anemia [2] - The approval effectively enhances the company's product pipeline in blood and hematopoietic system medications [2] - However, the sales of formulation products are subject to uncertainties due to potential changes in domestic pharmaceutical industry policies and market conditions [2]

Core Viewpoint - North China Pharmaceutical has received approval from the National Medical Products Administration for the registration of Adenosylcobalamin capsules (0.5mg), which are designed to inhibit abnormal fat synthesis in nerve myelin and promote the repair of damaged nerves [1] Group 1: Product Details - Adenosylcobalamin is effective in preventing and treating vitamin B12 deficiency, particularly in cases where dietary intake is insufficient due to conditions such as consuming diseases, hyperthyroidism, pregnancy, and lactation [1] - The product aids in normalizing glutathione levels, protecting nerve cells, and improving anemia by participating in heme synthesis [1] Group 2: Mechanism of Action - The drug blocks the occurrence and development of demyelination in nerve fibers and promotes protein and lipid synthesis [1] - It lowers abnormal TNFα levels, inhibits the occurrence of SACD, and participates in the tricarboxylic acid cycle to maintain normal cellular functions [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Adenosylcobalamin capsules (0.5mg), indicating a significant advancement in its product pipeline for blood and hematopoietic system medications [1] Group 1: Product Approval - The company has obtained the Drug Registration Certificate for Adenosylcobalamin capsules (0.5mg) [1] - Adenosylcobalamin is primarily used for the prevention and treatment of Vitamin B12 deficiency, particularly in cases of inadequate dietary intake due to various conditions such as consumptive diseases, hyperthyroidism, pregnancy, and lactation [1] - The approval confirms that the product meets the basic entry requirements for centralized procurement bidding and that its efficacy is equivalent to that of the original research product [1]

Core Insights - The increasing prevalence of electronic devices has heightened awareness of the potential visual hazards associated with prolonged screen exposure, leading to a surge in demand for lutein as a vital nutrient for eye health [1][3] - The children's market for lutein products has become a competitive battleground, driven by rising concerns among parents regarding children's vision health [1][15] Market Overview - The domestic market for lutein is estimated to reach nearly 6 billion yuan, with a compound annual growth rate (CAGR) of 19.8% from 2020 to 2024, significantly outpacing global market growth [4][3] - The eye care sector is the primary contributor to market growth, with annual sales of lutein soft capsules exceeding 200 million bottles [4] Competitive Landscape - The lutein market is characterized by intense competition across both health food and regular food sectors, with no dominant brand currently leading the market [2][20] - Major players in the extraction and processing segment include Chenguang Biotech, DSM, and Kemin, creating a "three-legged" competitive structure [4] Product Development - The market has seen a rapid increase in the registration of lutein health products, with over 150 products registered, primarily in capsule form [7][8] - Innovative product forms such as gummies and ready-to-drink beverages are gaining popularity, with the market for lutein gummies expected to exceed 1.5 billion yuan by 2024 [11] Consumer Trends - The demand for lutein products is driven by the rising incidence of myopia among children, with the overall myopia rate in Chinese children reaching 51.9% [18] - The average price of imported lutein products is significantly higher than that of domestic products, with imported items often exceeding 100 yuan per unit [17] Regulatory Environment - Lutein products are primarily classified as health foods and must undergo a registration process, as they are not included in the approved health food ingredient directory [9][14] - The lack of a clear definition for dietary supplements in China has led to many imported lutein products being marketed as regular foods, despite their health claims [13] Future Outlook - The lutein market is expected to continue evolving, with a focus on product differentiation and innovation to address the challenges of market saturation and consumer trust [20][22] - Companies are encouraged to invest in research and development to create unique products that can withstand competition and avoid the pitfalls of market homogenization [22]

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。 重要内容提示： 每股分配比例 A 股每股现金红利0.03元（含税） 相关日期 | 股份类别 | 股权登记日 | 最后交易日 | 除权（息）日 | 现金红利发放日 | | --- | --- | --- | --- | --- | | Ａ股 | 2025/7/24 | － | 2025/7/25 | 2025/7/25 | 证券代码：600812 证券简称：华北制药 公告编号：临 2025-042 华北制药股份有限公司 2024年年度权益分派实施公告 三、 相关日期 | 股份类别 | 股权登记日 | 最后交易日 | 除权（息）日 | 现金红利发放日 | | --- | --- | --- | --- | --- | | Ａ股 | 2025/7/24 | － | 2025/7/25 | 2025/7/25 | 四、 分配实施办法 差异化分红送转： 否 一、 通过分配方案的股东大会届次和日期 本次利润分配方案经公司2025 年 6 月 11 日的2024年年度股东大会审议通过。 二、 ...

近日，华北制药股份有限公司（以下简称"公司"）下属全资子公司 华北制药华胜有限公司（以下简称"华胜公司"）收到欧洲药品质量管理 局签发的硫酸多黏菌素 B 化学原料药欧洲药典适用性证书（以下简称"CEP 证书"），现将有关情况公告如下： 证券代码：600812 股票简称：华北制药 编号：临 2025-041 华北制药股份有限公司 关于下属公司收到化学原料药 CEP 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。 二、药品其他相关情况 硫酸多黏菌素 B（Polymyxin B Sulfate）用于治疗铜绿假单胞菌敏感菌 株引起的急性感染，是治疗铜绿假单胞菌敏感菌株引起的泌尿道、脑膜和 血流感染的首选药物。当潜在毒性较低的药物无效或禁用时，本品可用于 由以下微生物的敏感菌株引起的严重感染：流感嗜血杆菌，特别是脑膜感 染；大肠埃希菌，特别是尿路感染；产气杆菌，特别是菌血症；肺炎克雷 伯菌，特别是菌血症。 药品名称 硫酸多黏菌素 B / Polymyxin B Sulfate 产品剂型 原料药 证书编号 No. CEP 20 ...

Core Viewpoint - Huabei Pharmaceutical (600812.SH) announced that its wholly-owned subsidiary, Huasheng Company, received the European Pharmacopoeia suitability certificate for Sulbactam Polymyxin B chemical raw material, indicating recognition of the product's quality by the EU market and allowing sales in Europe [1] Group 1 - The certificate signifies that Huasheng Company is the third domestic manufacturer to obtain the CEP certificate for Sulbactam Polymyxin B, highlighting its competitive position in the market [1] - The total R&D expenditure for the drug has reached 10.99 million yuan, reflecting the company's investment in developing this product [1]

Investment Rating - The report indicates a positive outlook for the pharmaceutical and biotechnology sector, with a focus on innovative drug companies [2][3]. Core Insights - The pharmaceutical and biotechnology sector saw a weekly increase of 1.82%, outperforming the CSI 300 index (0.82%) and the Wind All A index (1.71%). The market is currently focused on the expectations surrounding semi-annual reports and business development (BD) activities [8][9]. - The launch of the 2025 National Basic Medical Insurance and Commercial Health Insurance innovative drug directory is a significant development. This directory will include high-innovation drugs that provide substantial clinical value and patient benefits, which are not covered by basic medical insurance but recommended for commercial health insurance [3][13]. - The report highlights the importance of the commercial health insurance sector in the payment for innovative drugs, suggesting that the accessibility of high-priced innovative drugs is expected to improve, particularly in the areas of cell and gene therapy [3][13]. Market Weekly Review - The medical research outsourcing sector led the gains with a 9.29% increase, primarily driven by WuXi AppTec's positive semi-annual report announcement. Conversely, offline pharmacies and other biological products experienced declines of -1.29% and -1.55%, respectively [8][9]. - Notable stock performances included Frontier Biotech-U (41.4%), Mediso (38.9%), and Lianhuan Pharmaceutical (38.6%) leading the gains, while ST Unimed (-18.5%), Shenzhou Cell-U (-13.4%), and Shutai Shen (-11.6%) faced significant losses [11][12]. Industry News and Key Company Announcements - The report outlines several key industry events, including the approval of innovative drugs and strategic partnerships among major pharmaceutical companies, which are expected to enhance their market positions and product offerings [13][16][17]. - The report also mentions significant financial forecasts from various companies, indicating strong growth potential in the sector, with some companies projecting net profit increases of over 100% year-on-year [17][18].