UNITED LAB (03933): Injection TUL108 obtained implied approval for clinical trials of new drugs in China.

UNITED LAB (03933) announced that its wholly-owned subsidiary Zhuhai UNITED LAB Co., Ltd. has received an implicit approval for clinical trials of the innovative drug TUL108 for injection developed independently by the company from the China National Medical Products Administration, with acceptance number CXHL2600206. TUL108 for injection is a novel broad-spectrum -lactamase inhibitor designed and developed independently by the company for the treatment of infections caused by Gram-negative or Gram-positive bacteria, including complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), lung infections, and bloodstream infections. TUL108 in combination with meropenem shows high sensitivity to carbapenem-resistant Gram-negative bacteria such as Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii, addressing the urgent need for coverage of carbapenem-resistant Gram-negative bacteria in clinical settings. TUL108 for injection obtained FDA approval for clinical trials in the United States on January 28, 2026. The development of TUL108 for injection will strengthen the company's leading position in the field of anti-infection. In the future, the company will continue to focus on the research and development of new products, continuously enhance its competitiveness and creativity in the pharmaceutical industry, and is expected to create greater returns for the company and its shareholders.