• NMPA’s response is based on the Phase 3 DRAGON interim analysis results
• Topline final data expected in Q4 2025
  
  

 Belite Bio, Inc. (NASDAQ: BLTE), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, announced that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has agreed to accept the New Drug Application (NDA) with priority review for Tinlarebant for the treatment of Stargardt disease based on the interim analysis results from the Phase 3 DRAGON trial.

“Having China NMPA agreed to review the NDA based on interim Phase 3 data is a remarkable milestone for Belite Bio and the Stargardt community,” said Dr. Tom Lin, Chairman and CEO of Belite Bio. “This milestone underscores the strength of the program and the urgent need for therapies in this devastating disease, where no approved treatment options exist. This achievement positions Belite Bio to advance Tinlarebant through the final stages of development and, if successful, bring the first treatment to people living with Stargardt disease.”

NMPA’s response is based on the interim analysis results showing statistical significance in the primary endpoint of the Phase 3 DRAGON trial. The Company remains on track to report final topline data from the Phase 3 DRAGON trial in the fourth quarter of 2025. These results are expected to be submitted to the NMPA as part of the NDA that is currently under preparation in accordance with China CDE’s guidance.

The pivotal Phase 3 DRAGON trial is a randomized, double-masked, placebo-controlled, global study designed to evaluate the safety and efficacy of Tinlarebant in adolescent patients with Stargardt disease. The trial enrolled 104 subjects across 11 jurisdictions, including the U.S., United Kingdom, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan, and Australia, with a 2:1 randomization (Tinlarebant:placebo). The primary efficacy endpoint is the growth rate of atrophic lesions, alongside the assessment of safety and tolerability.