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].

证券日报网讯 8月13日晚间，鲁抗医药发布公告称，近日，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（简称"该药品"）的《药品补充申请批准通知书》，该药品通过仿制药质量和疗效一 致性评价。 （编辑 任世碧） ...

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]

鲁抗医药公告，近日，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。头孢呋辛酯为 头孢呋辛的前体药，属于第二代头孢菌素类抗生素，作用机制为抑制细菌细胞壁合成，使细菌不能繁 殖。本品具有广谱抗菌作用，对化脓性链球菌、肺炎球菌、葡萄球菌、甲氧西林敏感株、卡他莫拉菌、 淋球菌、流感嗜血杆菌等有强大抗菌作用，对大肠杆菌、肺炎克雷伯菌、变形杆菌属等肠杆菌科细菌亦 有良好作用。 ...