创新药注射用头孢吡/恩美他唑巴坦研究开发进展

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关键词：注射用头孢吡/恩美他唑巴坦；广谱β-内酰胺酶；多重耐药；复杂尿路感染；获批上市中图分类号： R978.1+1 文献标识码：A 文章编号：1001-8751（2025）05-0297-06

Research and Development Progress of the Innovative Drug Cefepime/ Enmetazobactam for Injection

Liu Xin-rong （GrandPharma（China） Co.，Ltd.，Wuhan 430033）

Abstract： Cefepime and enmetazobactam for injection is a fixed-dose combination of fourth-generation cephalosporins and Extended-spectrum β -lactamases（ESBLs） inhibitors for intravenous injection，developed by Allecra for the treatment of infections caused by Multi-drug-resistant （MDR） gram-negative bacteria.The United States originally authorized cefepime/emtazobactam in February 2024 for the treatment of complex urinarytract infections （UTIs），including pyelonephritis brought on bysensitive bacteria，in patients aged18andup.InMarch 2024，the European Union granted market authorization for the drug.Innovative drugs cefepime and emetazobactam for injection are reviewed inthis article，along with significant advancements in their research and development.

Key words： cefepime and enmetazobactam for injection；extended-spectrum β -lactamases（ESBLs）；multidrug-resistant（MDR）； complicated urinary tract infections（cUTI）； approved for marketing

经Orchid公司许可，Allecra公司参与注射用头孢吡肟/恩美他唑巴坦（代码：AAI-202）研发，同时Advanz等公司也相继参与了开发。（剩余10291字）