Lin BioScience’s subsidiary, Belite Bio (“Belite”), announced that the interim analysis data from its Phase III trial of LBS-008 showed promising results. Following approval from China’s NMPA to submit a New Drug Application (NDA) for the treatment of Stargardt disease (STGD1) in adolescents, Belite today announced that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has also agreed to allow submission of a Conditional Marketing Authorization (CMA) application for STGD1.
Tom Lin, Chairman and CEO of Belite, stated, “We are extremely pleased with the outcome of our interactions with the UK MHRA. This is an exciting milestone for the Belite team. Our long-term dedication brings us one step closer to providing an effective therapy for patients with STGD1, a condition for which no treatment currently exists. We continue to engage proactively with regulatory authorities worldwide, advancing LBS-008 toward later-stage drug development, with the ultimate goal of becoming the first global therapy for this debilitating disease.”
Hendrik Scholl, MD, Chief Medical Officer of Belite, commented, “With consistent positive feedback from major regulatory authorities globally, we are encouraged and confident that the results from the DRAGON trial will provide a strong foundation for subsequent global filings and potential approvals.”
Belite noted that the UK MHRA’s positive response is based on the DRAGON trial’s interim analysis meeting CMA criteria. The company plans to announce top-line data from DRAGON in Q4 2025. These results will be incorporated into a full Marketing Authorization Application (MAA) to be submitted to the UK MHRA.
Lin BioScience further emphasized that as the DRAGON trial’s pivotal data approach release, China’s NMPA had already allowed Belite to submit the STGD1 NDA with priority review status. The UK MHRA’s agreement to accept a CMA application reflects strong recognition of LBS-008’s clinical results and therapeutic potential. The company will continue active communication with regulatory authorities worldwide. The Belite team aims to accelerate LBS-008’s market entry, bringing hope to patients with STGD1.
The two-year DRAGON trial enrolled 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. The study is a randomized, double-blind, placebo-controlled (2:1) global clinical trial designed to evaluate the efficacy of LBS-008 in STGD1 patients. The primary endpoint is the rate of growth of macular atrophy lesions, with secondary assessments evaluating safety and tolerability.
Resource: 仁新Belite獲英國同意，以期中分析結果提交條件式上市許可申請
