登录新浪财经APP 搜索【信披】查看更多考评等级 珠海润都制药股份有限公司（以下简称"公司"或"本公司"）近日收到国家药品监督管理局签发的布洛芬 片（以下简称"本品"）《药品注册证书》。现将有关情况公告如下： 本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误导性陈述或重大遗 漏。 一、药品基本情况 药品名称：布洛芬片 剂型：片剂 申请事项：药品注册(境内生产) 规格：0.2g 注册分类：化学药品3类 受理号：CYHS2401594 证书编号：2026S00459 药品批准文号：国药准字H20263388 药品注册标准编号：YBH31022025 审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要求， 批准注册，发给药品注册证书。同意本品按甲类非处方药管理。质量标准、说明书、标签及生产工艺照 所附执行。 二、药品的适应症 本品适用于缓解轻至中度疼痛如头痛、关节痛、偏头痛、牙痛、肌肉痛、神经痛、痛经。也用于普通感 冒或流行性感冒引起的发热。 三、对公司的影响及风险提示 公司高度重视药品研发，并严格控制药品研发、制造及销售环节的质量及安 全。此次布洛芬片 ...

ST葫芦娃（605199）(605199.SH)发布公告，公司近日收到国家药品监督管理局(以下简称"国家药监局") 核准签发的关于吸入用异丙托溴铵溶液《药品注册证书》。上述药品获得《药品注册证书》，将进一步 丰富公司产品线，对公司的发展起到积极作用。 ...

成大生物(688739.SH)公告，公司全资子公司成大生物(本溪)有限公司(简称"本溪子公司")于近日收到国 家药品监督管理局签发的冻干人用狂犬病疫苗(人二倍体细胞)(简称"人用二倍体狂犬疫苗")《药品注册 证书》。 ...

本公司及董事会全体成员保证信息披露内容的真实、准确和完整，没有虚假记载、误导性陈述或重大遗 漏。 登录新浪财经APP 搜索【信披】查看更多考评等级 近日，湖北广济药业股份有限公司（以下简称"公司"）收到国家药品监 督管理局核准签发的甲钴胺片的《药品注册证书》。现将相关情况公告如下： 一、基本情况 1.药品通用名称：甲钴胺片 2.受理号：CYHS2402791 3.证书编号：2026S00402 4.剂型：片剂 5.包装规格：10片/板×2板/盒 6.注册分类：化学药品4类 7.药品注册标准编号：YBH01362026 8.上市许可持有人名称：湖北广济药业股份有限公司 地址：湖北省黄冈武穴市大金广济药业生物产业园A区 10.审批结论：根据《中华人民共和国药品管理法》及有关规定，经审查，本品符合药品注册的有关要 求，批准注册，发给药品注册证书。质量标准、说明书、标签及生产工艺照所附执行。药品生产企业应 当符合药品生产质量管理规范要求方可生产销售。 11.药品批准文号：国药准字H20263341 二、药品的其他相关情况 甲钴胺片主要适用于周围神经病的治疗。 三、对公司的影响 本次甲钴胺片《药品注册证书》的获批，标志 ...

Core Viewpoint - The company has received a drug registration certificate for Tadalafil Tablets (20mg) from the Food and Drugs Authority of Ghana, allowing for legal sales in the country, which supports the company's international market expansion efforts [1] Group 1: Product Approval - The drug Tadalafil (20mg) is classified as a PDE5 inhibitor, used for treating erectile dysfunction and symptoms of benign prostatic hyperplasia [1] - The approval marks a significant step for the company in establishing a presence in the Ghanaian market [1] Group 2: Market Impact - Currently, there is no established sales for Tadalafil in Ghana, and even with potential sales, the revenue contribution is expected to be low relative to the company's overall revenue [1] - The acquisition of the drug registration certificate is not anticipated to have a significant impact on the company's near-term operating performance [1]

Core Viewpoint - Xinhua Pharmaceutical (000756.SZ) has received approval from the National Medical Products Administration for the registration of Glucosamine Sulfate Capsules, which are primarily used for treating primary and secondary osteoarthritis [1] Group 1: Product Approval - The approval of Glucosamine Sulfate Capsules enhances the company's formulation product portfolio [1] - This product is classified as a Category B item in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2025) [1] Group 2: Market Potential - The estimated sales revenue for Glucosamine Sulfate Capsules in Chinese public medical institutions is approximately RMB 850 million in 2024 [1] - The introduction of this product is expected to improve the company's overall competitiveness in the market [1] Group 3: Industry Considerations - The pharmaceutical sales business is subject to uncertainties influenced by industry policies and market conditions [1]

Core Viewpoint - The company announced that its wholly-owned subsidiary, Guangdong Shuanglin Biopharmaceutical Co., Ltd., has received the acceptance notice for the clinical trial registration of human thrombin from the National Medical Products Administration [1] Group 1: Regulatory Approval - The National Medical Products Administration has reviewed and accepted the drug registration application based on Article 32 of the Administrative Licensing Law of the People's Republic of China [1] - The human thrombin is indicated for external use only, aimed at controlling minor bleeding from capillaries and small veins when standard surgical techniques are ineffective or impractical [1] Group 2: Product Usage - The product can be used in conjunction with absorbable gelatin sponges for enhanced hemostatic effect [1]

Core Viewpoint - Jiangsu Lianhuan Pharmaceutical Co., Ltd. has received the Drug Registration Certificate for Lidocaine Hydrochloride Gel from the National Medical Products Administration, marking a significant milestone in the company's product development and regulatory compliance [1][4]. Group 1: Drug Registration Certificate Details - The Drug Registration Certificate pertains to Lidocaine Hydrochloride Gel, which is indicated for local anesthesia during procedures requiring such intervention [1]. - The company is one of three domestic enterprises that have obtained this Drug Registration Certificate for the product [1]. - The estimated sales revenue for Lidocaine Hydrochloride Gel in national secondary hospitals and above is approximately 40.86 million yuan in 2024 [1]. Group 2: R&D Investment and Production Approval - As of the announcement date, the cumulative R&D investment for this project is approximately 7.27 million yuan (unaudited) [2]. - This is the first production license obtained by the company in 2026 [3]. Group 3: Impact on the Company - The acquisition of the Drug Registration Certificate for Lidocaine Hydrochloride Gel enhances the company's product line and is expected to improve its market competitiveness [4]. - The impact of this certificate on the company's near-term operating performance is not anticipated to be significant [4].

中华人民共和国药品管理法实施条例 （2002年8月4日中华人民共和国国务院令第360号公布 根据2016年2月6日《国务院关于修改部分行政 法规的决定》第一次修订 根据2019年3月2日《国务院关于修改部分行政法规的决定》第二次修订 根 据2024年12月6日《国务院关于修改和废止部分行政法规的决定》第三次修订 2026年1月16日中华人民 共和国国务院令第828号第四次修订） 第一章 总则 第一条 根据《中华人民共和国药品管理法》（以下简称药品管理法），制定本条例。 第二条 从事药品研制、生产、经营、使用和监督管理活动，应当坚持以人民健康为中心，遵循科学规 律和伦理原则，全面防控风险。 第七条 以申请药品注册为目的开展药物非临床安全性评价研究活动的，应当由经过资格认定的药物非 临床安全性评价研究机构实施。申请药物非临床安全性评价研究机构资格认定应当向国务院药品监督管 理部门提出申请，提交证明其符合药物非临床研究质量管理规范的资料。国务院药品监督管理部门应当 组织开展审查，并自受理申请之日起20个工作日内作出决定。对符合规定条件的，准予许可并发给资格 证书；对不符合规定条件的，不予许可并书面说明理由。 药物非 ...

Core Viewpoint - Qianjin Pharmaceutical's subsidiary, Qianjin Xiangjiang Pharmaceutical, has received approval from the National Medical Products Administration for the registration of aluminum magnesium carbonate chewable tablets, enhancing the company's product pipeline and supporting sustainable development [1] Group 1 - The approved drug is a first-line medication for the digestive system, providing antacid, bile acid neutralization, and mucosal protection effects [1] - The approval of the drug registration certificate is equivalent to passing the consistency evaluation, which is a significant milestone for the company [1] Group 2 - The production and sales of the drug are subject to national policies and market environment changes, indicating a high level of uncertainty [1]