Lin BioScience announced on the 16th that its U.S. subsidiary, Belite Bio, has been notified by China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) that, based on the interim analysis results of the Phase 3 DRAGON trial of LBS-008 (Tinlarebant) for treating adolescent Stargardt Disease (STGD1), Belite may submit a New Drug Application (NDA) to the NMPA and has been granted priority review status.

Tom Lin (Lin Yu-Hsin), Chairman and CEO of Belite Bio, stated that the NMPA’s decision to accept the NDA ahead of the final data readout marks a significant milestone for the company and for Stargardt patients worldwide. The interim data further validates the clinical potential of LBS-008 and signifies that drug development for Stargardt disease—currently without any approved treatments—has entered a historic stage.

Lin noted that LBS-008 is now advancing into the final stage of drug development and is expected to become the world’s first approved therapy for STGD1.

Belite explained that the NMPA’s response was based on the DRAGON trial’s interim analysis, which demonstrated statistical significance in its primary efficacy endpoint. The company plans to announce the key top-line results from the DRAGON study in the fourth quarter of 2025 and, in accordance with CDE guidance, will include these results in the formal NDA submission.

Lin BioScience emphasized that the company has maintained active communication with regulatory agencies worldwide. The decision by Chinese authorities to accept the NDA and grant priority review before the final data release underscores strong confidence in the clinical outcomes and therapeutic potential of LBS-008. Lin BioScience and Belite will leverage global ophthalmology drug development expertise and institutional support to accelerate the commercialization of LBS-008, bringing new hope to STGD1 patients around the world.

The DRAGON trial is a two-year study enrolling 104 adolescent participants across 11 regions, including the United States, the United Kingdom, Germany, France, Belgium, Switzerland, the Netherlands, China, Hong Kong, Taiwan, and Australia. It adopts a randomized, double-blind, placebo-controlled (2:1) design. The primary endpoint evaluates the rate of growth in macular atrophy lesions, alongside assessments of the safety and tolerability of LBS-008.

Resource: 仁新子公司Belite斯特格病變新藥獲NMPA優先審評資格