UNITED LAB (03933): TUL321 Capsules receive approval for new drug clinical trials by the US FDA.

UNITED LAB (03933) announced that the Investigational New Drug (IND) application for the innovative drug TUL321 capsule developed by its wholly-owned subsidiary Zhuhai UNITED LAB Co., Ltd. has been approved by the Food and Drug Administration (FDA) in the United States, with the IND number 180385. In addition, the application for clinical trials in China has been submitted simultaneously and accepted. TUL321 capsule is a new generation complement factor B (CFB) inhibitor. The complement system is an important part of the innate immune system, and its activation products play a role in regulating phagocytosis, cell lysis, mediating inflammation, regulating immune responses, and clearing immune complexes, mainly through the activation of the classical, lectin, and alternative pathways. CFB is the core limiting serine protease of the complement system alternative pathway. Abnormal activation in pathological conditions leads to uncontrolled pathway activation, mediating tissue damage, and causing various diseases. Preclinical studies have shown that TUL321 capsules have a unique target binding mode and excellent penetration characteristics. They exhibit more significant therapeutic potential in the treatment of paroxysmal nocturnal hemoglobinuria (PNH), IgA nephropathy, age-related macular degeneration, multiple sclerosis, and myasthenia gravis compared to similar drugs. This approval is another significant advancement in the company's innovative research and development in the field of autoimmune disease treatment. In the future, the company will continue to focus on new product development, continuously enhance its competitiveness and creativity in the pharmaceutical industry, and is expected to create greater profits for the company and its shareholders.