Approval for cefiderocol granted in China to treat complicated urinary tract infections – Shionogi

Shionogi & Co. Ltd. announced that its group company, Shionogi China Co., Ltd, has received approval from the National Medical Products Administration (NMPA) of China for cefiderocol  for the treatment of complicated urinary tract infections including pyelonephritis caused by Gram-negative bacteria. This approval is based on positive results from an international multicenter clinical study and a randomized, double-blind, multicenter study conducted in China. In both studies, which aimed to verify non-inferiority to the comparator drug, cefiderocol demonstrated non-inferiority to imipenem/cilastatin and achieved the primary endpoint. Furthermore, no new safety concerns were identified and cefiderocol was well tolerated.

Antimicrobial resistance (AMR) is often referred to as a “silent pandemic” and is recognized as one of the most pressing global public health threats requiring urgent action. Without coordinated international efforts, it is projected that more than 39 million lives could be lost over the next 25 years. Meanwhile, treatment options remain limited, making this an area of high unmet medical need. With this approval, cefiderocol is expected to provide a new treatment option for patients in mainland China suffering from difficult-to-treat complicated urinary tract infections.

Prior to this approval, the Hainan Provincial Medical Products Administration had authorized its clinical use in the Boao Lecheng International Medical Tourism Pilot Zone in China.