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

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].