UNITED LAB's Investigational Antibiotic TUL108 Receives China NMPA Clearance for Clinical Trials

Stock News05-19

UNITED LAB (03933) announced that its wholly-owned subsidiary, Zhuhai United Laboratories Co., Ltd., has received an implied clinical trial approval from the China National Medical Products Administration (NMPA) for its self-developed Class 1 innovative drug, TUL108 for injection, under application number CXHL2600206. TUL108 for injection is a novel, broad-spectrum β-lactamase inhibitor designed and developed by the company. It is intended for treating 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. In combination with meropenem, TUL108 demonstrates high sensitivity against carbapenem-resistant pathogens such as Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii, offering comprehensive coverage for clinically challenging carbapenem-resistant Gram-negative bacteria. TUL108 for injection had previously received investigational new drug approval from the U.S. Food and Drug Administration (FDA) on January 28, 2026. The development of TUL108 for injection is expected to strengthen the company's leading position in the anti-infective field. Moving forward, the company remains committed to new product research and development, continuously enhancing its competitiveness and innovation within the pharmaceutical industry, which is anticipated to generate greater returns for the company and its shareholders.

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