本公司董事会及全体董事保证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、准确性和完整性依法承担法律责任。 近日，江苏吉贝尔药业股份有限公司（以下简称"公司"）收到国家药品监督管理局签发的《化学原料药 上市申请批准通知书》，现将相关情况公告如下： 一、基本信息 1、登记号：Y20240000024 2、化学原料药名称：通用名称：加替沙星；英文名/拉丁名：Gatifloxacin 3、化学原料药注册标准编号：YBY70952025 4、包装规格：3kg/桶 5、申请事项：境内生产化学原料药上市申请 6、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。质量标准、标签及生产工艺照所附执行。请继续积累亚硝胺杂质的研究数据，必要时完 善控制策略。 7、生产企业：名称：江苏吉贝尔药业股份有限公司；地址：江苏省镇江市高新技术产业开发园区 三、对公司的影响及风险提示 8、通知书有效期：至2030年10月21日 江苏吉贝尔药业股份有限公司董事会 二、药品的相关情况 2025年10月24日 公司本次获批的加替沙星原料药主要用于保障公司产品加替沙星滴眼 ...

Group 1 - The company, Jiangsu Jibeier Pharmaceutical Co., Ltd., has received the approval notice for the listing application of the chemical raw material drug Gatifloxacin from the National Medical Products Administration [1][2] - Gatifloxacin is a broad-spectrum antibacterial drug effective against various bacteria, including Gram-positive and Gram-negative bacteria, and is the main raw material for the company's Gatifloxacin eye drops [2] - The approval is valid until October 21, 2030, and the company is required to continue accumulating research data on nitrosamine impurities and improve control strategies as necessary [2] Group 2 - The approved Gatifloxacin raw material is primarily used to meet the production needs of the company's Gatifloxacin eye drops, and it is not expected to have a significant impact on the company's recent operations [3]

Core Viewpoint - The company, Jibeier (688566.SH), has received the approval notice for the marketing application of its chemical raw material, gatifloxacin, from the National Medical Products Administration, indicating a significant advancement in its product pipeline [1]. Group 1: Product Information - Gatifloxacin is a quinolone antibiotic effective against various bacteria, including Gram-positive and Gram-negative bacteria, as well as Chlamydia trachomatis [1]. - The product gatifloxacin eye drops, which utilize gatifloxacin as the main raw material, are primarily used for treating acute bacterial conjunctivitis caused by sensitive bacteria [1]. - The antibacterial action of gatifloxacin is achieved by inhibiting bacterial DNA gyrase and topoisomerase IV, thereby blocking the processes of DNA replication, transcription, and repair [1].

Core Viewpoint - The company, Jibeier (688566), has received approval from the National Medical Products Administration for its chemical raw material, gatifloxacin, which is the main ingredient in its gatifloxacin eye drops used for treating acute bacterial conjunctivitis caused by sensitive bacteria [1] Group 1 - The approval notification is specifically for the chemical raw material drug application [1] - Gatifloxacin eye drops are primarily indicated for acute bacterial conjunctivitis [1]