On October 15, 2025, Belite Bio, Inc. announced that the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) has agreed to accept a New Drug Application (NDA) for its oral therapy Tinlarebant with priority review for the treatment of Stargardt disease. The decision was based on interim analysis results from the Phase 3 DRAGON trial, marking the first regulatory approval milestone for the company in China.
The interim analysis demonstrated statistically significant improvement in the primary endpoint—reduction in the growth rate of atrophic lesions—in the 104 adolescent subjects enrolled in the DRAGON trial. The study employed a 2:1 randomization of Tinlarebant to placebo across 11 jurisdictions, including the United States, United Kingdom, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan, and Australia. The data showed a meaningful treatment effect that satisfied the NMPA’s criteria for priority review, a status that can accelerate the review timeline to 12–18 months.
This regulatory milestone is significant for Belite Bio because it opens the possibility of commercializing Tinlarebant in China, a market with an estimated 1.5 million patients with Stargardt disease and a growing demand for retinal therapeutics. The NMPA’s acceptance also signals confidence in the drug’s safety and efficacy profile, potentially boosting investor confidence and positioning the company for a broader global launch. The company plans to submit the full NDA package to the NMPA in the coming weeks, with an anticipated review period of 12 to 18 months, after which it could seek approval and begin sales in the Chinese market.
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