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]

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]