09:01 AM EDT, 10/15/2025 (MT Newswires) -- Belite Bio ( BLTE ) said Wednesday that China's National Medical Products Administration has agreed to review its New Drug Application for Tinlarebant to treat Stargardt disease under a priority review.

The company said the acceptance is based on interim results from its phase 3 Dragon study, which showed statistical significance in the primary endpoint. Belite said it expects to report the final topline data from the study in Q4. The results will be submitted to the agency as part of the application.

The trial is a global, placebo-controlled study evaluating Tinlarebant's safety and effectiveness in adolescent patients with Stargardt disease with 104 participants across 11 countries and regions, the company said.