United Laboratories Secures FDA IND Approval for TUL321 Capsule, a Next-Generation Complement Factor B Inhibitor

Bulletin Express04-28

Hong Kong – 28 April 2026 – United Laboratories International Holdings Limited announced that the U.S. Food and Drug Administration has cleared Investigational New Drug application No. 180385 for TUL321 Capsules, a Class 1 drug self-developed by its wholly owned subsidiary, Zhuhai United Laboratories Co., Ltd.

TUL321 targets complement factor B, the rate-limiting serine protease zymogen in the alternative complement pathway. Dysregulation of this pathway is implicated in paroxysmal nocturnal hemoglobinuria, IgA nephropathy, age-related macular degeneration, multiple sclerosis and myasthenia gravis. Preclinical studies cited by the company indicate that the compound’s unique binding mode and high permeability may offer superior therapeutic potential versus existing CFB inhibitors.

In parallel with the FDA clearance, the company has submitted and obtained acceptance for clinical-trial registration in China, positioning the asset for a synchronized multinational development program.

Management described the regulatory milestone as a further step in expanding the firm’s autoimmune-disease pipeline and pledged continued investment in innovative drug development to reinforce long-term competitiveness.

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