Ceftolozane

Multidrug-resistant Gram-negative bacterial infection is one of the core challenges in current clinical anti-infective therapy. As a fifth-generation cephalosporin anti-infective drug, cefiderocol exerts a bactericidal effect by specifically binding to bacterial penicillin-binding proteins (PBPs) and inhibiting the synthesis of cell wall peptidoglycan, and maintains strong antibacterial activity against multidrug-resistant strains including carbapenem-resistant Enterobacteriaceae and *Pseudomonas aeruginosa*. It is mainly used clinically to treat adult patients with complicated urinary tract infections, complicated intra-abdominal infections and hospital-acquired pneumonia, providing a new treatment option for high-risk groups with drug-resistant bacterial infections, such as immunodeficient patients and ICU patients with severe infections.

At present, the global cefiderocol market is still in the stage of rapid expansion. In 2023, the global market size was approximately USD 420 million, with a compound annual growth rate maintained at around 37%. In terms of the domestic market, with the improvement of diagnosis and treatment specifications for drug-resistant bacteria and the increase of drug accessibility, the sales amount of cefiderocol in domestic sample hospitals exceeded RMB 210 million in 2023, with a growth rate far exceeding the global average level. The current competitive landscape is dominated by originator pharmaceutical companies, and a number of domestic pharmaceutical companies have deployed generic drug R&D. In the future, with the approval and launch of generic drugs, the market penetration rate is expected to further increase.

The originator company of cefiderocol is Shionogi & Co., Ltd. of Japan, with the originator brand name Zevtera®. Its core compound patent will expire in 2029 in Europe, in 2030 in the United States, and in 2031 in China. The dosage form of the originator product for marketing is injection, with specifications of 0.5g and 1.0g. The originator product has been included in the FDA Reference Listed Drug Catalog, and it has not yet been included in the *List of Chemical Drugs* in China. In terms of domestic API registration, there is no approved cefiderocol API registration number in A status. The originator preparation was approved for marketing in China through the priority review procedure in 2021. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO can provide a full set of cefiderocol impurity reference standards. The relevant products meet the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA. Most products are available from stock, and orders placed before 16:00 can be shipped on the same day, which can fully meet the demand for impurity reference standards of pharmaceutical companies in the process of generic drug R&D, quality research and production.