Cefmetazole

Mixed infections caused by Gram-negative bacteria and anaerobic bacteria are common difficulties in clinical anti-infective treatment, and the insufficient stability of traditional cephalosporins against β-lactamase has long restricted their therapeutic efficacy. Cefmetazole, a second-generation semi-synthetic cephamycin antibiotic, exerts a bactericidal effect by inhibiting the biosynthesis of bacterial cell walls. The methoxy group introduced at the 7α position of its structure makes it highly stable against most β-lactamases, and it also has good antibacterial activity against enzyme-producing strains. Clinically, it is mainly used to treat respiratory tract infections, biliary tract infections, urinary tract infections, obstetric and gynecological infections caused by sensitive bacteria, and to prevent infections before and after surgery. It is especially suitable for mixed infection cases combined with anaerobic bacterial infection, covering multiple applicable populations including adults and children.

The current global market size of cefmetazole preparations is approximately USD 1.2 billion, with the Chinese market accounting for more than 45%, and the compound annual growth rate has maintained at 6.2% in the past three years. The domestic market is dominated by generic drugs. With the advancement of the consistency evaluation, more than 10 enterprises have passed the evaluation for cefmetazole sodium for injection. After the implementation of centralized procurement, the terminal price has dropped by more than 60%, and the accessibility in primary medical institutions has been significantly improved. The domestic supply in the upstream API segment is stable, and local substitution has been basically realized, with imported APIs accounting for less than 5%.

The original research enterprise of cefmetazole is Sankyo Co., Ltd. of Japan (now Daiichi Sankyo), and the original research trade name is "Cefmetazon". The core compound patent expired in 2005 in major markets such as Japan and the United States, and the compound patent expired in China in 2006. The main dosage form approved by the original research is injection, with specifications including 0.25g, 0.5g, 1.0g and 2.0g. It has been included in the China Listed Drug Catalogue as a reference preparation, and is also included in the FDA Reference Preparation Catalogue. In terms of domestic API registration, nearly 20 cefmetazole sodium APIs have obtained CDE registration numbers (A status) at present, more than 30 enterprises have been approved for domestic cefmetazole sodium for injection, and the original research preparation has also been imported and marketed in China. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of cefmetazole impurity reference standards. Most products are in stock, and orders for in-stock products placed before 16:00 will be shipped on the same day. All products fully comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can provide stable reference standard support for pharmaceutical enterprises in API R&D, quality research and consistency evaluation work.