Lin BioScience (仁新醫藥), through its subsidiary Belite Bio (Nasdaq: BLTE), announced the completion of enrollment for its DRAGON II Phase II/III trial of LBS-008 (Tinlarebant). The trial reached its target of 60 adolescent subjects across Japan, the US, and the UK.

• Regulatory Timeline: Chairman and CEO Dr. Tom Lin confirmed that the company remains on track to submit a New Drug Application (NDA) to the US FDA in the first half of 2026.
• Strategic Enrollment: The inclusion of 15 Japanese subjects is critical for future regulatory submissions to Japan's PMDA, facilitating a streamlined commercial launch in the Asian market.
• Clinical Efficacy: LBS-008 previously showed a 36% reduction in lesion growth rate (p=0.0033) in its global Phase III DRAGON trial. As the first drug to demonstrate clinical efficacy for Stargardt Disease (STGD1), it holds significant potential as a first-in-class treatment for this rare blinding eye disease.

Resource: 仁新 LBS-008斯特格病變 DRAGON II二/三期試驗完成收案