Cefcapene

Lower respiratory tract infections such as community-acquired pneumonia and acute exacerbation of chronic bronchitis have long ranked among the top in the number of visits for primary infectious diseases. The rise in pathogenic bacterial drug resistance has put forward higher requirements for the antibacterial activity of oral anti-infective drugs. Cefcapene belongs to the fourth-generation oral cephalosporin antibiotics. It exerts a bactericidal effect by inhibiting the biosynthesis of bacterial cell walls, and has broad-spectrum antibacterial activity against both Gram-positive bacteria and Gram-negative bacteria. In particular, it has a significant effect on common respiratory pathogenic bacteria such as penicillin-resistant Streptococcus pneumoniae and Haemophilus influenzae. Clinically, it is mainly used to treat mild to moderate infections in the respiratory tract, skin and soft tissue, urogenital tract and other parts caused by sensitive bacteria, and the applicable population covers adult and pediatric patients with infections.

The global market size of cephalosporin anti-infective drugs has remained steadily above USD 13 billion, of which oral cephalosporins account for nearly 45%. As a representative variety of the fourth-generation oral cephalosporins, cefcapene has maintained a compound annual growth rate of 7.2% in the past five years. In terms of the domestic market, cefcapene is a variety included in the centralized procurement catalogue. At present, 6 domestic enterprises have obtained approval for generic preparations of cefcapene, and the supply of its API has long relied on imports in the past. With the maturity of domestic production processes, the proportion of domestic APIs in the past three years has increased from less than 20% to 62%, and the market competition has gradually shifted from the original research monopoly to a comprehensive competition of cost and quality compliance.

The original research enterprise of cefcapene is Shionogi Pharma Co., Ltd. of Japan, and the original research brand name is "Flomox". The expiration date of its core compound patent in Japan is 2006, and the compound patent in China has expired in 2008. The main dosage form of the original research is tablet, with specifications of 75mg and 150mg. This variety has been included in the *Catalogue of Reference Preparations of Chemical Drugs* of China, and is also included in the FDA Reference Preparations Catalogue. There are currently 8 cefcapene API registration records on the domestic CDE API registration platform, of which 5 are in "A" status, which can be used in association with domestic preparation declarations. A total of 12 cefcapene pivoxil preparation varieties have been approved for marketing in China. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of cefcapene impurity reference standards. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can fully meet the needs for impurity reference standards in the process of API R&D, quality research and production.