UNITED LAB (03933): TUL321 Capsule Obtained Implicit Approval for Clinical Trials of New Drugs in China

UNITED LAB (03933) announced that the 1st innovative drug TUL321 capsule developed by its wholly-owned subsidiary Zhuhai UNITED LAB Pharmaceuticals Limited has received the implicit approval for new drug clinical trials from the China National Medical Products Administration, with acceptance numbers CXHL2600375, CXHL2600376 and CXHL2600377. TUL321 capsule is a next-generation complement factor B (CFB) inhibitor. The complement system is an important component of the innate immune system, and its activation products can play roles in phagocytosis, cell lysis, inflammation mediation, immune response regulation, and immune complex clearance, mainly through the activation of the classical, lectin, and alternative pathways. CFB is the core limiting serine protease of the alternative pathway of the complement system. Abnormal activation in pathological conditions leads to uncontrolled activation of the alternative pathway, mediating tissue damage, and thereby causing various diseases. Preclinical studies have shown that TUL321 capsule has a unique target-binding mode and excellent penetrative characteristics, demonstrating outstanding therapeutic potential in diseases such as paroxysmal nocturnal hemoglobinuria (PNH), IgA nephropathy, age-related macular degeneration, multiple sclerosis, and myasthenia gravis. TUL321 capsule has already received FDA approval for new drug clinical trials on April 28, 2026. This approval marks another important milestone 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, enhance competitiveness and creativity in the pharmaceutical industry, and is expected to create greater returns for the company and its shareholders.