Jennifer Kim

Michael Okunewitch

Yi Chen

Basma Radwan Ibrahim

Bruce Jackson

Boris Peaker

Marc Goodman

- China's National Medical Products Administration (NMPA) has agreed to accept Belite Bio's New Drug Application (NDA) for **Tinlarebant** for **Stargardt disease** with **priority review**.  **[1889109_a5f634e5d9784d0f959cc7ff417c940b_1]** 
- This decision is based on **statistically significant interim analysis results** from the **Phase 3 DRAGON trial**.  **[1889109_a5f634e5d9784d0f959cc7ff417c940b_0]** **[1889109_a5f634e5d9784d0f959cc7ff417c940b_1]** 
- Belite Bio expects to report **topline final data** from the Phase 3 DRAGON trial in **Q4 2025**.  **[1889109_a5f634e5d9784d0f959cc7ff417c940b_0]** **[1889109_a5f634e5d9784d0f959cc7ff417c940b_1]** 
- **Tinlarebant** is a novel oral therapy for Stargardt disease, a condition for which **no approved treatment options currently exist**.  **[1889109_a5f634e5d9784d0f959cc7ff417c940b_1]** **[1889109_a5f634e5d9784d0f959cc7ff417c940b_2]**

Belite Bio Receives Priority Review for Tinlarebant NDA in China

- **Belite Bio Inc. (BLTE)** announced the **completion of the last subject visit** in its **pivotal Phase 3 DRAGON clinical trial** for **Tinlarebant**, a treatment for Stargardt disease type 1 (STGD1).  **[1889109_5353fd13bb1c4af0abd022e2339dcc82_1]** 
- The trial enrolled **104 adolescent subjects**, with **94 subjects completing the study**.  **[1889109_5353fd13bb1c4af0abd022e2339dcc82_1]** 
- The company expects to report **top-line results in Q4 2025** and plans to file **New Drug Applications in 1H 2026**.  **[1889109_5353fd13bb1c4af0abd022e2339dcc82_1]** 
- **Tinlarebant** has received **Breakthrough Therapy, Fast Track, and Rare Pediatric Disease Designations** in the U.S., and **Orphan Drug Designation** in the U.S., Europe, and Japan for STGD1.  **[1889109_5353fd13bb1c4af0abd022e2339dcc82_0]** **[1889109_5353fd13bb1c4af0abd022e2339dcc82_1]**

BELITE BIO (BLTE)