Jeil Pharmaceutical said it received marketing approval from the Ministry of Food and Drug Safety (MFDS) for Fetroja (ingredient: cefiderocol), a treatment for multi-drug resistant (MDR) gram-negative bacterial infections.

Developed by Shionogi, Fetroja is the world’s first siderophore cephalosporin antibiotic, designed to overcome the resistance mechanisms that limit the efficacy of conventional antibiotics. By binding to iron, the drug is absorbed into bacterial cells through their own iron transport channels (porins), allowing it to combat resistant bacteria effectively.

Fetroja has demonstrated in-vitro activity against various antibiotic-resistant (AMR) pathogens, including carbapenem-resistant Enterobacterales (CRE), carbapenem-resistant Acinetobacter baumannii (CRAB), and carbapenem-resistant Pseudomonas aeruginosa (CRPA) producing metallo-beta-lactamases (MBL).

In July 2022, Jeil Pharmaceutical signed an exclusive domestic supply agreement with Ping An-Shionogi, a subsidiary of Shionogi, securing the development and commercialization rights for Fetroja in Korea.

The approval permits the use of Fetroja for adult patients in treating complicated urinary tract infections (cUTI), including pyelonephritis, as well as hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), caused by susceptible bacteria.

Prior to its approval in Korea, Fetroja had already secured authorization in over 10 countries, including the U.S., Europe, and Japan. In April 2024, MFDS designated it as a national essential medicine due to its significance in responding to public health crises and enhancing national health security.

Jeil Pharmaceutical expects this novel mechanism to provide a promising new treatment option for infections caused by MDR pathogens that have been challenging to treat with existing therapies.

“The brand name Fetroja embodies the concept of a 'Trojan Horse,’ as the drug penetrates bacterial cells through iron porin channels to defeat pathogens,” a Jeil official said. “It will serve as a critical treatment option for patients suffering from complicated urinary tract infections and ventilator-associated pneumonia caused by MDR bacteria.”