Cefathiamidine

As the first generation cephalosporin independently developed in China, cefathiamidine exerts its bactericidal effect by inhibiting the biosynthesis of bacterial cell walls, and has good antibacterial activity against Gram-positive bacteria and some Gram-negative bacteria. Especially, its antibacterial effect against Enterococcus spp. is superior to that of other cephalosporins, and it is a common choice for the clinical treatment of respiratory tract infections, biliary tract infections, urinary tract infections, sepsis and other soft tissue infections caused by sensitive bacteria. The applicable population covers adults and pediatric patients who meet the medication indications, filling the previous gap in the clinical treatment of Enterococcus infections with cephalosporins.

At present, the domestic market size of cefathiamidine is stable at around 1.5 billion yuan. In recent years, affected by the promotion of hierarchical diagnosis and treatment and the implementation of standardized use of antibacterial drugs at the primary level, the annual compound growth rate has remained at around 3.2%. The competition pattern is characterized by the dominance of domestic generics. As it is a domestically independently developed variety, no imported original research product participates in the market competition. Currently, there are 12 approved preparation manufacturers, and the API suppliers are concentrated in 5 pharmaceutical enterprises in South China and East China. The public medical institution procurement side has been included in the centralized procurement of provincial alliances, and the winning bid price has decreased by an average of 47% compared with that before the centralized procurement, further improving the clinical accessibility.

Cefathiamidine was originally developed by Baiyunshan Pharmaceutical General Factory of Guangzhou Baiyunshan Pharmaceutical Holdings Co., Ltd., with the trade name "Xianlisu". The core compound patent expired in 2009. At present, the main dosage form on the market is cefathiamidine for injection, and the commonly used specifications include 0.5g and 1.0g. The original research product has been included in the *Catalogue of Chemical Reference Preparations* issued by the National Medical Products Administration. Up to now, there are 6 cefathiamidine API registration information in the CDE API Registration Platform, among which 3 are in Status A, which can be legally supplied for the declaration and production of associated preparations. There are a total of 27 cefathiamidine preparation varieties approved in China. (Data as of October 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of cefathiamidine impurity reference standards, most of which are in stock. Spot products ordered before 16:00 can be shipped on the same day. All reference standards comply with the regulatory requirements of the Chinese Pharmacopoeia, FDA and other regulations, and fully meet various technical requirements of pharmaceutical enterprises for API quality research, preparation stability investigation and registration declaration.