Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration certificate of Finasteride tablets, which are indicated for the treatment and management of benign prostatic hyperplasia (BPH) [1] Group 1 - The approved Finasteride tablets are designed to treat and control BPH and to prevent urinary system events, including reducing the risk of acute urinary retention [1] - The medication can help shrink enlarged prostates, improve urinary flow, and alleviate symptoms associated with prostatic hyperplasia [1]

Core Viewpoint - Xinhua Pharmaceutical's subsidiary, Xinda Pharmaceutical, has received approval for Finasteride tablets, which are indicated for the treatment of benign prostatic hyperplasia (BPH) and prevention of urinary system events, enhancing the company's product portfolio and market opportunities [2] Group 1: Product Approval and Market Impact - Xinda Pharmaceutical has been granted a drug registration certificate for Finasteride tablets by the National Medical Products Administration [2] - The Finasteride tablets are classified as a Category B drug under the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog (2025) [2] - The estimated sales revenue for Finasteride tablets in Chinese public medical institutions is approximately RMB 1.45 billion in 2024 [2] Group 2: Strategic Implications - The approval of Finasteride tablets is expected to enrich the company's product line and explore new market segments [2] - The pharmaceutical sales business is subject to uncertainties due to potential changes in domestic pharmaceutical policies and market conditions [2]

Core Viewpoint - Shandong Xinhua Pharmaceutical Co., Ltd. has received approval for the registration of Finasteride tablets, which will enhance its product portfolio and open new market opportunities [1] Group 1 - The company's wholly-owned subsidiary, Shandong Zibo Xinda Pharmaceutical Co., Ltd., has obtained the drug registration certificate for Finasteride tablets from the National Medical Products Administration [1] - The registration certificate for Finasteride tablets was granted in August 2025, indicating a future product launch [1] - This development is expected to contribute positively to the company's growth by diversifying its product offerings [1]

7月31日，昂利康公告，公司获得国家药品监督管理局核准签发的西格列汀二甲双胍缓释片《药品注册 证书》。西格列汀二甲双胍缓释片为复方制剂，适用于正在接受西格列汀和二甲双胍缓释片联合治疗的 成人2型糖尿病患者。公司于2024年1月获得西格列汀二甲双胍缓释片药品上市许可申请受理通知书，并 于近日获得国家药监局批准。根据国家相关政策规定，本次获得《药品注册证书》视同通过一致性评 价。 ...

此次公司获得复方聚乙二醇电解质散(Ⅲ)注册证书，标志着公司具备了在国内市场销售该规格药品的资 格，将进一步丰富公司产品管线和产品品类，增强了公司的核心竞争力。 一品红（300723）(300723.SZ)发布公告，公司全资子公司广州一品红制药有限公司于近日收到国家药 品监督管理局核准签发的关于复方聚乙二醇电解质散(Ⅲ)的《药品注册证书》，复方聚乙二醇电解质散 (Ⅲ)适应症为：用于以下情况之前的患者结肠清洁准备：--内窥镜或放射检查--结肠手术，本品适用于成 人。 ...

Core Viewpoint - The company, Anglikang (002940), has received a drug registration certificate from the National Medical Products Administration for Mesobam Injection, which is intended for the treatment of acute skeletal muscle pain or discomfort [1] Group 1: Product Information - Mesobam Injection is classified as a Class 3 chemical drug with a specification of 10ml:1g [1] - The approval of the drug registration certificate will enhance the company's product pipeline [1] Group 2: Market Considerations - The sales performance of Mesobam Injection may be influenced by national policies and changes in the market environment, indicating a significant level of uncertainty [1]

Core Viewpoint - North China Pharmaceutical Co., Ltd. has received the Drug Registration Certificate for Adenosylcobalamin Capsules (0.5mg) from the National Medical Products Administration, indicating the product's compliance with quality and efficacy standards for generic drugs [1][2]. Group 1: Drug Registration Details - The Drug Registration Certificate for Adenosylcobalamin Capsules (0.5mg) was approved on July 29, 2025, after being submitted for review in April 2024 [2][4]. - Adenosylcobalamin is primarily used for the prevention and treatment of Vitamin B12 deficiency and related conditions, such as megaloblastic anemia [2][5]. Group 2: Research and Development - The company has invested a total of 10.9382 million yuan in research and development for this product [3]. - The product is expected to be produced and marketed following the receipt of the registration certificate [4]. Group 3: Market Situation - A total of 27 companies, including North China Pharmaceutical, hold the Drug Registration Certificate for Adenosylcobalamin Capsules (0.5mg) in China [5]. - The sales volume for the capsule form is projected to be approximately 29,000 units in 2024, with total sales across all forms expected to reach around 1.5 billion units, reflecting a 19% increase from 2023 [5]. Group 4: Impact on the Company - The approval of the Drug Registration Certificate enhances the company's product pipeline in hematology and hematopoietic system medications, meeting the basic requirements for centralized procurement bidding [6].

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。 ...

福元医药(601089.SH)公告称，公司全资子公司福元药业收到国家药监局颁发的联苯苄唑溶液《药品注 册证书》，批准该药品生产。该药品用于皮肤真菌病的治疗，包括白癣、念珠菌症和癜风。福元药业于 2024年1月12日获得申报受理通知书，并于近日获得国家药监局批准。根据国家相关政策规定，本次获 得《药品注册证书》视同通过一致性评价。米内网数据显示，2024年中国三大终端六大市场联苯苄唑溶 液销售额约为3.75亿元。 ...

Group 1 - The core point of the article is that Jichuan Pharmaceutical's subsidiary has received a drug registration certificate for Compound Polyethylene Glycol (3350) Electrolyte Powder, which is intended for the treatment of chronic constipation and fecal impaction [1] - The product is chocolate-flavored and is one of the five companies in China that have passed the consistency evaluation for this drug [1] - According to data from Minai Network, the sales revenue for Compound Polyethylene Glycol Electrolyte in urban public hospitals and retail pharmacies in China is projected to be 838 million yuan and 8 million yuan respectively in 2024 [1] Group 2 - The approval of the drug registration certificate is expected to have a positive impact on the company's future development [1] - However, the market development cycle for the drug's launch may take time and is subject to uncertainties influenced by pharmaceutical industry policies and procurement bidding [1]