Lin BioScience today, on behalf of its subsidiary Belite, announced that the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has agreed that Belite may submit a New Drug Application (NDA) for LBS-008 (Tinlarebant) to treat adolescent Stargardt disease (STGD1), based on the positive interim analysis from the Phase III DRAGON clinical trial. The NDA submission has been granted priority review status.

Belite Chairman and CEO Lin Yu-Hsin stated that the NMPA’s agreement to review the NDA based on the DRAGON interim results represents a highly significant milestone for both the company and patients with Stargardt disease. This achievement not only underscores the clinical relevance of LBS-008 but also marks a historic milestone in the development of a therapy for a condition that currently has no approved treatments. The advancement brings LBS-008 closer to the final stages of drug development and positions it to potentially become the world’s first treatment for STGD1.

According to Belite, the NMPA’s decision was based on the DRAGON interim analysis, which demonstrated statistical significance on the primary efficacy endpoint. The company plans to release the trial’s top-line results in Q4 2025, and these data will be incorporated into the NDA submission in accordance with CDE guidance.

Lin BioScience emphasized that the company maintains active communication with regulatory authorities globally. Notably, the NMPA granted permission for NDA submission and priority review before the release of DRAGON’s key results, highlighting strong recognition of LBS-008’s clinical outcomes and therapeutic potential. With Belite’s professional expertise in ophthalmic drug development and support from international institutional investors, the team is poised to accelerate LBS-008’s market entry, offering hope to STGD1 patients.

The DRAGON trial is a two-year, randomized, double-blind, placebo-controlled global study with a 2:1 treatment-to-placebo ratio. It enrolled 104 adolescent participants across 11 regions, including the United States, United Kingdom, Germany, France, Belgium, Switzerland, the Netherlands, China, Hong Kong, Taiwan, and Australia. The study evaluates the efficacy of LBS-008 in STGD1 patients, with the primary endpoint being the growth rate of macular atrophy lesions, while also assessing the safety and tolerability of the drug.

Resource: 治STGD1期中分析結果佳，仁新子公司Belite提交中國新藥查登申請獲准