证券代码：600789 证券简称：鲁抗医药 公告编号：2025—037 一、药品基本信息 药品名称：注射用 CIGB-814 剂型：注射剂 注册分类：化学药品 1 类 适应症：类风湿性关节炎 山东鲁抗医药股份有限公司 关于注射用 CIGB-814 的 I 期临床试验完成首例受试者入组的公告 本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。 山东鲁抗医药股份有限公司（以下简称"公司"）于 2024 年 11 月收到国家药 品监督管理局核准签发的注射用 CIGB-814 的《药物临床试验批准通知书》，具 体内容详见公司于 2024 年 11 月 12 日在指定信息披露媒体披露的《山东鲁抗医 药股份有限公司关于获得药物临床试验批准通知书的公告》（公告编号： 2024-060）。 注射用 CIGB-814 已经启动 I 期临床试验，并于近日完成首例受试者入组。 现将相关情况公告如下： 成临床试验方可进行药品注册上市许可申请。 由于药物研发的特殊性，药物从临床试验到投产的周期长，环节多，易受不 可预测的因素影响，在临床试验中可能因为各种潜 ...

鲁抗医药公告，公司于 2024 年 11 月收到国家药品监督管理局核准签发的注射用 CIGB-814 的《药物临 床试验批准通知书》。注射用 CIGB-814已经启动 I 期临床试验，并于近日完成首例受试者入组。该药 品为免疫调节剂，适应症为类风湿性关节炎。公司将根据药物研发的实际进展情况及时履行披露义务。 ...

Core Viewpoint - Shandong Lukang Pharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for its Cefuroxime Axetil Oral Suspension, which has passed the consistency evaluation for generic drug quality and efficacy [1][2]. Drug Information - Drug Name: Cefuroxime Axetil Oral Suspension - Dosage Form: Oral Suspension - Specification: 0.125g - Approval Number: National Drug Approval H20010810 - Drug Standard: YBH14862025 - Registration Category: Chemical Drug - Marketing Authorization Holder: Shandong Lukang Pharmaceutical Co., Ltd. - Manufacturing Company: Chengdu Better Pharmaceutical Co., Ltd. - Approval Conclusion: The product has passed the consistency evaluation for generic drug quality and efficacy [1]. Market and R&D Situation - Cefuroxime Axetil is a prodrug of Cefuroxime, belonging to the second generation of cephalosporin antibiotics, which inhibits bacterial cell wall synthesis, preventing bacterial reproduction. It has broad-spectrum antibacterial activity against various bacteria, including Streptococcus pyogenes, Streptococcus pneumoniae, Staphylococcus aureus, and others [2]. - There are currently four approved numbers for Cefuroxime Axetil Oral Suspension in China, with three companies having passed the consistency evaluation by the National Medical Products Administration. According to PDB data, the domestic sales of Cefuroxime Axetil are estimated to be approximately 1.087 billion yuan in 2024 [2]. - The company has invested approximately 12.82 million yuan in research and development for this drug since the consistency evaluation work began [3]. Impact on the Company - The approval of Cefuroxime Axetil Oral Suspension through the consistency evaluation is expected to enhance the market competitiveness of the drug. However, drug sales are subject to uncertainties influenced by national policies and market conditions [4].

Core Viewpoint - The company, LuKang Pharmaceutical, has received approval from the National Medical Products Administration for its drug, Cefuroxime Axetil Dry Suspension, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The approval notification for the drug was issued on August 13 [1] - The drug is referred to as Cefuroxime Axetil Dry Suspension [1] - The approval indicates that the drug meets the standards for quality and efficacy as a generic medication [1]

证券代码：600789 证券简称：鲁抗医药 公告编号：2025—036 山东鲁抗医药股份有限公司 关于头孢呋辛酯干混悬剂通过一致性评价的公告 本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。 注册分类：化学药品 上市许可持有人：山东鲁抗医药股份有限公司 近日，山东鲁抗医药股份有限公司（以下简称"公司"）收到国家药品监督管 理局颁发的关于头孢呋辛酯干混悬剂（以下简称"该药品"）的《药品补充申请批 准通知书》（证书编号：2025B02754），该药品通过仿制药质量和疗效一致性 评价。现将相关情况公告如下： 一、药品证书基本信息 药品名称：头孢呋辛酯干混悬剂 剂型：口服混悬剂 规格：0.125g 批准文号：国药准字 H20010810 药品标准：YBH14862025 经查询，国内现有头孢呋辛酯干混悬剂批准文号 4 个，已有 3 家企业通过国 家药品监督管理局一致性评价审批。根据 PDB 数据显示，头孢呋辛酯 2024 年国 内销售额约为 10.87 亿元。 该药品开展一致性评价工作以来，公司累计研发投入约为 1282 万元人民币 （ ...

Core Viewpoint - The company has received approval from the National Medical Products Administration for the drug Cefuroxime Axetil dry suspension, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Product Information - Cefuroxime Axetil is a prodrug of Cefuroxime and belongs to the second generation of cephalosporin antibiotics, which work by inhibiting bacterial cell wall synthesis, preventing bacterial reproduction [1] Group 2: Research and Development - The company has invested approximately 12.82 million RMB (1.282 million) in research and development for the consistency evaluation of this drug since the initiation of the project [1]

Core Viewpoint - The company, LuKang Pharmaceutical (600789.SH), has received approval from the National Medical Products Administration for its drug, Cefuroxime Axetil Dry Suspension, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Company Information - LuKang Pharmaceutical has been granted a "Drug Supplement Application Approval Notice" for Cefuroxime Axetil Dry Suspension (Certificate No: 2025B02754) [1] - The drug is a prodrug of Cefuroxime and belongs to the second generation of cephalosporin antibiotics [1] - The mechanism of action of the drug involves inhibiting bacterial cell wall synthesis, preventing bacterial reproduction [1] Group 2: Drug Characteristics - Cefuroxime Axetil exhibits broad-spectrum antibacterial activity against various bacteria, including Streptococcus pyogenes, Streptococcus pneumoniae, Staphylococcus aureus (methicillin-sensitive strains), Haemophilus influenzae, and Neisseria gonorrhoeae [1] - The drug also shows good efficacy against Enterobacteriaceae such as Escherichia coli, Klebsiella pneumoniae, and Proteus species [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for the drug Cefuroxime Axetil dry suspension, which has passed the consistency evaluation of generic drug quality and efficacy [1] Group 1: Drug Approval - The approval notification for Cefuroxime Axetil dry suspension is identified by certificate number 2025B02754 [1] - The drug is a prodrug of Cefuroxime and belongs to the second generation of cephalosporin antibiotics [1] Group 2: Mechanism and Efficacy - The mechanism of action involves inhibiting bacterial cell wall synthesis, preventing bacterial reproduction [1] - The drug exhibits broad-spectrum antibacterial activity against various pathogens, including Streptococcus pyogenes, Streptococcus pneumoniae, Staphylococcus aureus, and others [1] - It also shows good efficacy against Enterobacteriaceae such as Escherichia coli, Klebsiella pneumoniae, and Proteus species [1]

资金流向方面，8月7日主力资金净流出5364.03万元，近五日累计净流出2.17亿元。 风险提示：市场有风险，投资需谨慎。 鲁抗医药属于化学制药行业，主要业务涵盖医药制造、生物农药等领域。公司全资子公司山东鲁抗生物 农药有限责任公司生产苏云金杆菌（以色列亚种），可用于灭杀蚊子幼虫。 消息面上，公司在投资者互动平台表示，其子公司具备生产灭蚊相关产品的能力。 截至2025年8月7日收盘，鲁抗医药股价报10.21元，较前一交易日下跌1.16%。当日成交额4.16亿元，换 手率4.53%，总市值91.75亿元。 ...

Core Viewpoint - The company has a product that can effectively kill mosquito larvae, specifically through the use of Bacillus thuringiensis israelensis [2] Company Information - The company's wholly-owned subsidiary, Shandong Lukang Biological Pesticide Co., Ltd., produces Bacillus thuringiensis (Israel strain) [2]