Federal Pharmaceutical (03933): Injection TUL108 Receives FDA Approval for New Drug Clinical Trials

Stock News01-28

Federal Pharmaceutical (03933) announced that on January 28, 2026, the Investigational New Drug (IND) application for its Class 1 innovative drug, Injection TUL108, independently developed by its wholly-owned subsidiary Zhuhai United Laboratories Co., Ltd., was approved by the U.S. Food and Drug Administration (FDA), with the IND number 178724. Injection TUL108 is a novel, ultra-broad-spectrum beta-lactamase inhibitor independently designed and developed by the company, intended for the treatment of infections caused by Gram-negative or Gram-positive bacteria, including complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), as well as lung and bloodstream infections. TUL108 in combination with meropenem demonstrates high sensitivity against carbapenem-resistant Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii, achieving comprehensive coverage against clinically challenging carbapenem-resistant Gram-negative bacteria. The development of Injection TUL108 will strengthen the company's leading position in the anti-infective field. Moving forward, the company will continue to dedicate itself to the research and development of new products, consistently enhancing its competitiveness and innovation within the pharmaceutical industry, which is expected to generate greater returns for the company and its shareholders.

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