Belite Bio files Japan NDA for drug

• Belite Bio submitted a New Drug Application in Japan for tinlarebant, an investigational treatment for Stargardt disease type 1.
• The filing follows the U.S. FDA’s acceptance of a tinlarebant NDA with Priority Review and a February 12, 2027 target action date.
• Belite Bio said tinlarebant could become a potential treatment option for STGD1, a rare inherited retinal disease with no approved therapies in Japan.

Belite Bio (NASDAQ:BLTE) submitted a New Drug Application in Japan for tinlarebant, an investigational once-daily oral therapy for Stargardt disease type 1, under Japan’s Sakigake Designation System.

The filing with Japan’s Ministry of Health, Labour, and Welfare follows a U.S. New Drug Application that the FDA accepted with Priority Review and a Prescription Drug User Fee Act target action date of February 12, 2027.

The company said STGD1 affects an estimated 9,500 people in Japan and currently has no approved treatments, while the Japan application is being reviewed alongside the ongoing U.S. regulatory process.

Belite Bio is developing tinlarebant for inherited retinal diseases and said the therapy is being evaluated as a potential treatment for patients with Stargardt disease type 1.

If approved, Belite Bio said tinlarebant could become the first approved treatment for STGD1 and the first ophthalmology product to receive Sakigake designation in Japan.