Jeil Pharmaceutical obtains domestic approval for Shionogi super antibiotic 'Cefiderocol'

Expectations for Treating Patients with Multidrug-Resistant Bacterial Infections

Jeil Pharmaceutical announced on the 19th that it has received domestic marketing approval from the Ministry of Food and Drug Safety for the multidrug-resistant gram-negative bacterial infection treatment 'Petroza 1 gram (active ingredient: Cefiderocol Tosylate Hydrate)'.

This approval authorizes the use of Petroza for adult patients to treat complicated urinary tract infections including pyelonephritis caused by susceptible bacteria, as well as hospital-acquired pneumonia including ventilator-associated pneumonia.

Prior to this domestic approval, Petroza had been approved in more than 10 countries worldwide including the United States, Europe, and Japan, and in April of last year, it was designated as a national essential medicine necessary for public health crisis response and the promotion of public health.

Developed by Shionogi, Petroza is the world's first siderophore cephalosporin antibiotic. To overcome the reduced efficacy caused by resistance mechanisms in existing antibiotics, it binds to iron and is absorbed into bacterial cells through the bacteria's own iron (Fe) porin channels. This mechanism exhibits strong antibacterial effects and is expected by the company to present new possibilities for treating multidrug-resistant hospital-acquired infections that were difficult to manage with existing treatment options.

It has demonstrated activity in in-vitro experiments against various antibiotic-resistant (AMR) pathogens such as carbapenem-resistant Enterobacteriaceae (CRE), carbapenem-resistant Acinetobacter baumannii (CRAB), and metallo-beta-lactamase (MBL) producing carbapenem-resistant Pseudomonas aeruginosa (CRPA).

A Jeil Pharmaceutical official stated, "Petroza is an innovative antibiotic with a brand meaning that conquers pathogens by utilizing the 'Trojan horse' mechanism, penetrating pathogens through iron porin channels. It will be an important treatment option for patients with complicated urinary tract infections including pyelonephritis and ventilator-associated pneumonia, which were difficult to treat due to multidrug-resistant bacterial infections."

Jeil Pharmaceutical previously secured the development and commercialization rights for Petroza by signing an exclusive domestic supply agreement with Ping An-Shionogi in July 2022.

This content was produced with the assistance of AI translation services.