Belite Bio announces China’s NMPA agreed to accept NDA for Tinlarebant

Belite Bio (BLTE) 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.”