UNITED LAB(03933.HK): TUL321 Capsule Granted Implied Approval for Clinical Trials of New Drug in China

NewTimeSpace News: The United Laboratories International Holdings Ltd (03933.HK) released a voluntary announcement on June 11, 2026, disclosing that TUL321 Capsule has been granted implied approval for clinical trials of new drug in China.

TUL321 Capsule is a new-generation complement factor B (CFB) inhibitor. The complement system is a key part of innate immunity. As the core rate-limiting zymogen of the alternative pathway of the complement system, abnormal activation of CFB under pathological conditions will cause the alternative pathway to get out of control, trigger tissue damage and further lead to various diseases. Preclinical studies show that TUL321 Capsule features a unique target binding mode and excellent permeability, and presents remarkable therapeutic potential for diseases including paroxysmal nocturnal hemoglobinuria (PNH), IgA nephropathy, age-related macular degeneration, multiple sclerosis and myasthenia gravis.

The product received clinical trial approval from the US FDA on April 28, 2026. This approval marks another major progress achieved by the Company in innovative R&D for the treatment of autoimmune diseases.

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