Japanese pharmaceutical company Shionogi has announced that Chinese authorities have accepted its application to manufacture and sell Cefiderocol, a key antibiotic for treating antimicrobial-resistant infections that existing antibiotics cannot address. This marks a significant step in Shionogi’s efforts to expand its global footprint in the fight against drug-resistant bacteria.
A Shionogi group company has been conducting Phase 3 clinical trials in China, demonstrating the drug’s efficacy and safety. Following successful trial results, the company submitted its application for approval, which has now been accepted by Chinese regulatory authorities.
Cefiderocol was first launched by Shionogi in the U.S. in 2020, where it has contributed to a notable increase in the company’s overseas revenue. For the April-June period of this year, Shionogi reported a 25% year-on-year increase in overseas revenue, excluding royalty income, reaching 15 billion yen (approximately $105 million). This growth has been largely driven by strong sales of Cefiderocol in the U.S. and Europe.
The drug received approval for manufacturing and sale in Japan in 2023, further solidifying its position in key markets. Shionogi’s expansion into China represents a critical move to address the rising global challenge of antimicrobial resistance, offering a potent solution for infections that have become resistant to other treatments.
