Belite Bio Announces China NMPA Agrees to New Drug Application with Priority Review based on Interim Analysis Results for the Treatment of Stargardt Disease with Tinlarebant

Core Insights - Belite Bio, Inc. has received acceptance from China's NMPA for a priority review of the New Drug Application (NDA) for Tinlarebant, aimed at treating Stargardt disease, based on interim analysis results from the Phase 3 DRAGON trial [1][2] Company Overview - Belite Bio is a clinical-stage drug development company focused on novel therapeutics for degenerative retinal diseases with significant unmet medical needs, including Stargardt disease and geographic atrophy [5] - The lead candidate, Tinlarebant, is an oral therapy designed to reduce the accumulation of vitamin A-based toxins in the eye, which are linked to retinal diseases [4][5] Clinical Trial Details - The Phase 3 DRAGON trial is a randomized, double-masked, placebo-controlled study evaluating the safety and efficacy of Tinlarebant in 104 adolescent patients with Stargardt disease across 11 jurisdictions [3] - The primary efficacy endpoint of the trial is the growth rate of atrophic lesions, with safety and tolerability also being assessed [3] Regulatory Milestones - The NMPA's acceptance of the NDA is a significant milestone for Belite Bio and the Stargardt community, highlighting the urgent need for effective therapies in this area [2] - Final topline data from the Phase 3 DRAGON trial is expected to be reported in Q4 2025, which will be submitted to the NMPA as part of the NDA [2][7]