Core Viewpoint - The company has received approval from the National Medical Products Administration for the registration of Adenosylcobalamin capsules (0.5mg), which are expected to have significant therapeutic benefits in treating neurological conditions [1] Company Summary - The approved product, Adenosylcobalamin capsules, is designed to inhibit abnormal fat synthesis in nerve myelin, block the occurrence and development of nerve fiber demyelination, and promote the synthesis of proteins and lipids to repair damaged nerves [1] - The capsules also lower abnormal TNFα levels, inhibit the occurrence of SACD, participate in the tricarboxylic acid cycle, and promote the metabolism of three major substances to maintain normal cellular functions [1] - The product normalizes glutathione levels to protect nerve cells and participates in heme synthesis to improve anemia [1] - The company has invested a total of 10.9382 million yuan in research and development for this product to date (unaudited) [1]

Core Viewpoint - North China Pharmaceutical has received the drug registration certificate for Adenosylcobalamin capsules (0.5mg) from the National Medical Products Administration, indicating a significant regulatory approval for the company’s product line [1] Group 1: Company Developments - The company announced the approval of Adenosylcobalamin capsules, which are primarily used for the prevention and treatment of Vitamin B12 deficiency [1] - The product is also indicated for supplementation when dietary intake of Vitamin B12 is insufficient and for treating megaloblastic anemia [1]

Core Viewpoint - North China Pharmaceutical (600812.SH) has received approval from the National Medical Products Administration for the registration certificate of Adenosylcobalamin capsules (0.5mg) [1] Group 1: Product Information - Adenosylcobalamin can inhibit abnormal fat synthesis in nerve myelin, blocking the occurrence and development of nerve fiber demyelination [1] - It promotes protein and lipid synthesis, repairing damaged nerves, and lowers abnormal TNFα levels, inhibiting the occurrence of SACD [1] - The product participates in the tricarboxylic acid cycle, promoting the metabolism of three major substances, and maintains normal cell function [1] Group 2: Medical Applications - Adenosylcobalamin is primarily used for the prevention and treatment of vitamin B12 deficiency, especially when dietary intake is insufficient due to conditions like consumptive diseases, hyperthyroidism, pregnancy, and lactation [1] - It is also indicated for megaloblastic anemia and other related conditions [1]

Core Viewpoint - 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 [1] Group 1: Product Approval and Market Impact - The newly approved product is primarily used for the prevention and treatment of Vitamin B12 deficiency, which is increasingly needed due to insufficient dietary intake, as well as for megaloblastic anemia [1] - The approval enhances the company's product pipeline in blood and hematopoietic system medications, filling a gap in their offerings [1] Group 2: Industry Considerations - The sales of formulation products are subject to uncertainties due to potential changes in domestic pharmaceutical industry policies and market environment [1]

Group 1 - The core point of the article is that Huabei Pharmaceutical has received the drug registration certificate for Adenosylcobalamin capsules from the National Medical Products Administration [2] - The revenue composition for Huabei Pharmaceutical in 2024 is as follows: Chemical preparations account for 44.02%, chemical raw materials account for 26.72%, biological preparations account for 16.36%, pharmaceutical intermediates account for 6.23%, and pharmaceutical and other logistics trade account for 4.61% [2]

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]