证券代码：600513 证券简称：联环药业 公告编号：2026-008 江苏联环药业股份有限公司 关于公司获得《药品注册证书》的公告 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。 江苏联环药业股份有限公司（以下简称"公司"）于近日收到国家药品监督管理局（以下简称"国家药监 局"）核准签发的关于盐酸利多卡因凝胶（以下简称"该药品"）的《药品注册证书》，现将相关情况公 告如下： 本次公司获得盐酸利多卡因凝胶的《药品注册证书》，进一步丰富了公司的产品线，有助于提升公司产 品的市场竞争力。上述《药品注册证书》的取得预计不会对公司近期经营业绩产生重大影响。 四、风险提示 公司高度重视药品研发，并严格控制药品研发、生产、销售各环节的质量安全。由于药品的生产、销售 易受到国内医药行业政策变动、招标采购、市场变化等因素影响，存在不确定性，敬请广大投资者审慎 决策，注意投资风险。 二、药品的其他情况 一、《药品注册证书》的主要内容 盐酸利多卡因凝胶适用于局麻药、经尿道施行检查和治疗需局部麻醉者。截至目前，包括公司在内，国 内共有三家企业取得该药 ...

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 ...

千金药业1月26日公告，公司下属子公司千金湘江药业收到国家药品监督管理局核准签发的铝碳酸镁咀 嚼片《药品注册证书》。该药品为消化系统一线用药，具有抗酸、抗胆汁、保护黏膜的功效。铝碳酸镁 咀嚼片获得药品注册证书，视同通过一致性评价，进一步丰富公司产品管线，有利于公司的可持续发 展。但药品的生产和销售容易受到国家政策、市场环境变化等因素影响，具有较大不确定性。 ...

恩华药业公告称，近日获国家药监局核准签发的化学药品右酮洛芬氨丁三醇注射液《药品注册证书》， 规格为2ml:50mg，剂型为注射剂，有效期24个月，批准文号有效期至2031年1月13日。该药品是一种非 甾体抗炎镇痛药，用于成人不适合口服给药的急性中度至重度术后疼痛。这是公司首个围手术期注射用 非甾体抗炎药，丰富了产品管线，将提升市场竞争力和业绩。不过，生产销售可能受不确定因素影响。 ...

Core Viewpoint - Fosun Pharma's subsidiary, Suzhou Erye Pharmaceutical Co., Ltd., has recently had its drug registration application for injectable lactulose erythromycin accepted by the National Medical Products Administration [1] Group 1: Company Developments - The cumulative R&D investment for the injectable lactulose erythromycin by the group is approximately RMB 6.33 million (unaudited) as of December 2025 [1] - The sales revenue for injectable lactulose erythromycin in mainland China (excluding Hong Kong, Macau, and Taiwan) is projected to be around RMB 170 million in 2024 according to IQVIA CHPA data [1]

Core Viewpoint - Meheco's wholly-owned subsidiary, Meheco Tiankang, has received the drug registration certificate for Liosiguat tablets from the National Medical Products Administration, enhancing the company's market competitiveness in the treatment of chronic thromboembolic pulmonary hypertension and arterial pulmonary hypertension [1] Group 1: Company Developments - The drug Liosiguat acts as a soluble guanylate cyclase (sGC) agonist, expanding blood vessels through the NO-sGC-cGMP pathway [1] - Meheco Tiankang is now qualified to produce and sell Liosiguat tablets in the domestic market following the approval [1] - The approval marks a significant milestone for Meheco Tiankang, as it joins two other approved companies, Qilu Pharmaceutical and Jiangsu Huayang Pharmaceutical, in the domestic market [1] Group 2: Market Potential - The global sales forecast for Liosiguat tablets in 2024 is approximately $494.16 million, with expected sales in China around $10.38 million [1] - The approval of Liosiguat tablets is expected to enhance the company's product competitiveness in a growing market [1] Group 3: Future Considerations - Future sales of Liosiguat tablets may be influenced by various uncertainties, including policy changes, market demand, and competition from similar drugs [1]

Group 1 - The core point of the article is that Lifan Pharmaceutical's subsidiary, Chengzhi Biological, has received approval from the National Medical Products Administration for the drug registration certificate of Loxoprofen Sodium Oral Solution, marking a significant milestone for the company [1] - Loxoprofen Sodium is a non-steroidal anti-inflammatory drug (NSAID) with effective analgesic, anti-inflammatory, and antipyretic properties [1] - As of the announcement date, there are no imported products approved for sale in the domestic market, making Chengzhi Biological the eighth company in China to hold the drug registration for this product [1] Group 2 - The acquisition of the drug registration certificate will further enrich Lifan Pharmaceutical's product pipeline and enhance its market competitiveness [1] - However, the production and sales of the drug remain subject to policy and market factors, indicating potential uncertainties [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for its exclusive distribution of injectable type A botulinum toxin produced by Huons BioPharma Co., Ltd, marking a significant milestone in its strategic layout [1] Group 1 - The approval of the injectable type A botulinum toxin product is a key milestone in the company's strategic planning [1] - The product will enhance the company's core competitiveness by providing a more comprehensive solution to customers when combined with existing products [1]

Group 1 - The core viewpoint of the article is that Aimeike (300896.SZ) has received approval from the National Medical Products Administration for the drug registration certificate of its exclusive distribution of injectable type A botulinum toxin products produced by Huons BioPharma Co., Ltd. in China, including Macau and Hong Kong [1] - The acquisition of the drug registration certificate for the injectable type A botulinum toxin product is a key milestone in the company's strategic layout [1] - This product, combined with existing offerings, will provide customers with a more comprehensive solution, enhancing the company's core competitiveness [1]

Core Viewpoint - China Medical (600056.SH) announced that its wholly-owned subsidiary, Hainan Tongyong Sanyang Pharmaceutical Co., Ltd. (referred to as "Sanyang Pharmaceutical"), has received the drug registration certificate for Nicergoline Tablets from the National Medical Products Administration, which is expected to enhance the company's product line and strengthen its position in the neurological medication sector [1]. Group 1 - Sanyang Pharmaceutical's Nicergoline Tablets are primarily used to improve motivation deficits caused by sequelae of cerebral infarction and are also applicable for vascular dementia, particularly in early treatment to enhance cognitive and memory functions, as well as to alleviate disease severity [1]. - The approval of the drug registration certificate is beneficial for enriching the company's product portfolio and further developing its presence in the neurological medication field [1]. - This development will accumulate valuable experience for the company's future generic drug development [1].