Belite Bio, Inc.

Belite Bio, Inc. is a clinical-stage biopharmaceutical company dedicated to developing novel therapeutics for retinal degenerative eye diseases with significant unmet medical needs, as well as certain metabolic diseases. The company's headquarters are located in San Diego, California, USA, though it is incorporated in the Cayman Islands.

Belite Bio's primary product candidate is Tinlarebant (LBS-008), an orally administered therapy currently in Phase 3 clinical trials. Tinlarebant is designed to treat Stargardt disease type 1 (STGD1) and geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD), by reducing the accumulation of toxic vitamin A by-products in ocular tissue through the modulation of Retinol Binding Protein 4 (RBP4). The company's pipeline also includes LBS-009, an anti-RBP4 oral therapy in preclinical development for liver diseases such as non-alcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), type 2 diabetes, and gout.

In recent developments, Belite Bio initiated a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for Tinlarebant in STGD1, with completion anticipated by the second quarter of 2026. Tinlarebant has received several designations, including Orphan Drug Designation in the U.S., Europe, and Japan, Rare Pediatric Disease designation and Fast Track Designation in the U.S., and Sakigake Designation in Japan. The pivotal Phase 3 DRAGON trial for STGD1 demonstrated positive topline results, showing a 35.7% reduction in macular lesion growth. The Phase 3 PHOENIX study for Geographic Atrophy has completed enrollment. The company is led by Dr. Yu-Hsin Lin, Chairman and CEO.