Cefotetan

Drug-resistant Gram-negative bacterial infection has always been a difficulty in clinical anti-infective treatment. The emergence of the third-generation cephamycin antibiotics has provided a better treatment option for such infections. As a typical cephamycin drug, cefotetan has a 7-α methoxy group introduced into its chemical structure, which enhances its stability against β-lactamase. Its mechanism of action is to inhibit the biosynthesis of bacterial cell walls, and it has strong antibacterial activity against common Gram-negative bacteria and anaerobic bacteria such as Escherichia coli, Klebsiella pneumoniae, and Bacteroides fragilis. Clinically, it is mainly used for lower respiratory tract infections, abdominal infections, urinary tract infections, sepsis and obstetric and gynecological infections caused by susceptible bacteria, and is especially suitable for empiric treatment of mixed aerobic and anaerobic bacterial infections, covering adult and pediatric patient groups that meet the medication indications.

The current global market size of cefotetan is approximately USD 320 million. Driven by the rising clinical demand for the treatment of drug-resistant bacterial infections, the compound annual growth rate in the past 3 years has remained at 4.7%. In terms of the domestic market, with the improvement of the standardization of prophylactic medication in the surgical perioperative period, the proportion of clinical use of cephamycins has increased year by year, and the annual average growth rate of the dosage of cefotetan in the high-risk population with ESBLs-producing bacterial infections is about 8.2%. The competitive landscape is dominated by generic drugs, with the market share of original research products less than 10%. Domestic API suppliers are concentrated in North China and East China. At present, there are 6 enterprises that have passed the CDE API registration, and the overall supply pattern is relatively stable.

The original research enterprise of cefotetan is Shionogi Pharma Co., Ltd. of Japan, with the original brand name Cefotan. Its core compound patent for the US market expired in 2005, and the core compound patent in China has expired. The main dosage form approved by the original research is cefotetan disodium for injection, with specifications of 1g and 2g. The original injection has been included in the FDA Orange Book Reference Listed Drug Catalog, but has not yet been included in the Chinese *Catalog of Reference Listed Drugs for Chemical Products*. In China, at present, 7 enterprises have obtained A-status registration numbers for cefotetan APIs after passing the CDE approval, and a total of 11 enterprises have obtained approval for the marketing of cefotetan disodium for injection preparations. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO can provide a full set of cefotetan impurity reference standards, which can fully meet the needs of impurity qualitative and quantitative research in the R&D process. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, helping API and preparation enterprises efficiently complete R&D declaration and quality control work.