BrightGene Bio-Medical Technology Co., Ltd.

A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin and/or Sulfonylureas in Patients With Type 2 Diabetes

BGM0504, a once-weekly injection from BrightGene Bio-Medical, is being tested against semaglutide as add-on therapy to metformin and/or sulfonylureas in adults with type 2 diabetes. The open-label phase 3 trial enrolls 537 participants in China with expected completion in March 2026. This represents a direct challenge to Novo Nordisk's Ozempic franchise in the Chinese market from a domestic biosimilar competitor. The head-to-head design against branded semaglutide signals BrightGene's confidence in demonstrating non-inferiority for regulatory approval and market access positioning.