Cephapirin

Infectious diseases remain a major burden on global public health, among which respiratory tract, urinary tract infections and skin and soft tissue infections caused by Gram-positive bacteria account for more than 30%, and the clinical demand for cephalosporin antibacterial agents with high efficacy and low toxicity is stable for a long time. Cefapirin belongs to the first-generation cephalosporin antibiotics, which exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls. It has outstanding antibacterial activity against common Gram-positive bacteria such as Streptococcus pneumoniae, Staphylococcus aureus (non-methicillin-resistant strains) and Streptococcus pyogenes, and also has a certain effect on some Gram-negative bacteria such as Escherichia coli and Proteus mirabilis. Clinically, it is mainly used for mild to moderate respiratory tract infections, urinary tract infections, skin and soft tissue infections caused by sensitive bacteria, and can also be used for infection prevention before surgical operations, and the applicable population covers adult and pediatric patients with no history of cephalosporin allergy.

The current global market size of cefapirin API is about USD 120 million, with the compound annual growth rate maintained at around 3.2%, and the demand mainly comes from generic preparation enterprises and clinical inventory replenishment demand. In terms of the domestic market, with the improvement of the standardization of antibacterial drug use in primary medical institutions, the clinical application scenarios of first-generation cephalosporins are gradually recovering. The winning bid price of cefapirin preparations is stable in the range of RMB 15-22 per vial, and the annual growth rate of API demand is about 4.1%. In terms of the competitive landscape, the compound patent of cefapirin has expired for many years, and there is no core patent restriction. At present, domestic API production is dominated by local enterprises, with the production capacity of leading enterprises accounting for more than 65% of the overall market. It has not been included in the scope of national centralized volume procurement, so the market competition is relatively mild.

The original research enterprise of cefapirin is Eli Lilly and Company of the United States, with the original research trade name Cefadyl, and the core compound patent expired globally in 1982. The main dosage form of the original research product is cefapirin sodium for injection, with common specifications of 0.5g and 1g. The original research product has been included in the FDA Reference Listed Drug Catalogue, but it has not been included in the *Catalogue of Reference Listed Drugs for Chemical Drugs* in China for the time being. Up to now, the API Registration Platform of the Center for Drug Evaluation (CDE) of the National Medical Products Administration has no cefapirin valid registration number that can be publicized, and there is also no cefapirin preparation variety approved for marketing 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 impurity reference standards for cefapirin API. Most of the products have sufficient spot reserves. Spot orders placed before 16:00 can be delivered on the same day. All products comply with the compliance requirements of multiple regulatory systems such as Chinese Pharmacopoeia and FDA, and can fully meet the demand for impurity reference standards in the process of API R&D, quality research and production.