Jeil’s super-antibiotic cefiderocol approved in Korea

Gains expectations as a new treatment option for patients with multidrug-resistant bacteria infections

Jeil Pharmaceutical (CEO Seok-je Sung) announced on the 19th that it has received approval from the Ministry of Food and Drug Safety to market the drug Fetroja Inj 1g’ (cefiderocol sulfate tosylate) for the treatment of multidrug-resistant gram-negative bacterial infections.

 

With the approval, adult patients may use Fetroja for the treatment of the following infections caused by susceptible Gram-negative microorganisms: • Complicated Urinary Tract Infections (cUTI), including Pyelonephritis • Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) Prior to this domestic approval, Fetroja Inj has been approved in more than 10 countries around the world, including the US, Europe, and Japan, and was designated by the Ministry of Food and Drug Safety as a national essential medicine in April 2024 as a medicine necessary for responding to public health crises and promoting public health.

 

Fetroja Inj, which was developed by Shionogi, is the world's first siderophore cephalosporin antibiotic, it binds with iron and is then absorbed into the cell through the bacteria's iron-porin channels to overcome the problem of existing antibiotics losing their effectiveness due to resistance.

 

Through this different mechanism of action, it shows a strong antibacterial effect, and Jeil Pharmaceutical expects it to present new possibilities in the treatment of infections caused by multidrug-resistant pathogens that have been difficult to effectively treat with existing treatment options.

 

Fetroja Inj demonstrated in-vitro activity against various antibiotic-resistant (AMR) pathogens, including carbapenem-resistant enterobacteriaceae (CRE), carbapenem-resistant acinetobacter baumannii (CRAB), and carbapenem-resistant pseudomonas aeruginosa (CRPA) that produce metallo-beta-lactamase (MBL).

 

A Jeil Pharmaceutical official said, “Fetroja is an innovative antibiotic that was named to conquer pathogens by using the Trojan horse mechanism of penetrating pathogens through the iron (Fe) forin channel.

 

It will be an important treatment option for patients with complicated urinary tract infections, including nephropyelitis, and ventilator-associated pneumonia, which was difficult to treat due to multidrug-resistant bacteria infection.” Jeil Pharmaceutical signed an exclusive domestic supply agreement with Ping An-Shionogi in July 2022 and secured the rights to develop and commercialize ‘Fetroja Inj.’ Meanwhile, Shionogi is a global research-oriented pharmaceutical company established in 1878, and has a long history and expertise in the development of infectious disease treatments.

 

In particular, it is conducting continuous research and development in the fields of antibiotics, antiviral drugs, and central nervous system treatments, and currently has subsidiaries in Japan, the United States, Europe, and China.

 

Ping An-Shionogi was established in 2020 as a joint venture between the Japanese company Shionogi and the Chinese company Ping An, and introduced the Asian rights to “Fetroja Inj.” However, in December 2024, Shionogi acquired all of Ping An's shares and incorporated it as a subsidiary of Shionogi.