United Lab gains NMPA clearance to begin clinical trials for next-generation CFB inhibitor TUL321 Capsules

Bulletin Express06-11

Hong Kong-listed pharmaceutical group The United Laboratories International Holdings Limited (United Lab) has obtained Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA) to initiate clinical trials for TUL321 Capsules, a Class 1 self-developed medicine targeting complement factor B (CFB).

The NMPA authorisation—granted under reference numbers CXHL2600375, CXHL2600376 and CXHL2600377—allows the company’s wholly-owned subsidiary, Zhuhai United Laboratories Co., Ltd., to commence human studies on the oral formulation.

TUL321 Capsules are designed as a new-generation, highly permeable CFB inhibitor aimed at modulating the alternative pathway of the complement system, whose dysregulation is implicated in multiple immune-mediated disorders. Pre-clinical data cited by the company indicate therapeutic potential in paroxysmal nocturnal hemoglobinuria, IgA nephropathy, age-related macular degeneration, multiple sclerosis and myasthenia gravis.

The Chinese approval follows United Lab’s receipt of U.S. Food and Drug Administration IND clearance for the same candidate on 28 April 2026, underscoring parallel clinical development paths in two major regulatory jurisdictions.

Management highlighted the decision as a milestone in expanding the group’s autoimmune disease pipeline and reiterated its strategic focus on bolstering R&D capabilities to strengthen long-term competitiveness and shareholder value.

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