The company has announced that its wholly-owned subsidiary, Zhuhai United Laboratories Co., Ltd., has received implied clinical trial approval from China's National Medical Products Administration for the Class 1 innovative drug TUL321 capsule, with application numbers CXHL2600375, CXHL2600376, and CXHL2600377.
The TUL321 capsule is a new-generation complement factor B (CFB) inhibitor. The complement system is a crucial component of innate immunity, with its activation products performing functions such as opsonization, cell lysis, inflammation mediation, immune response regulation, and clearance of immune complexes, primarily activated via the classical, lectin, and alternative pathways.
CFB is the core rate-limiting serine protease zymogen of the complement system's alternative pathway. Its abnormal activation under pathological conditions can lead to a loss of control in the alternative pathway, mediating tissue damage and thereby triggering various diseases.
Preclinical studies indicate that the TUL321 capsule possesses a unique target-binding mode and excellent permeability characteristics, demonstrating superior therapeutic potential in treating diseases such as paroxysmal nocturnal hemoglobinuria (PNH), IgA nephropathy, age-related macular degeneration, multiple sclerosis, and myasthenia gravis.
The TUL321 capsule had previously received approval for clinical trials from the U.S. Food and Drug Administration (FDA) on April 28, 2026. This latest approval marks another significant advancement in the company's innovative research and development within the field of autoimmune disease treatment.
Moving forward, the company remains committed to the research and development of new products, continuously enhancing its competitiveness and creativity within the pharmaceutical industry, with the expectation of creating greater value for the company and its shareholders.
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