Hua Medicine Advances Dorzagliatin Expansion Beyond China with Hong Kong NDA Acceptance

Hua Medicine's NDA for dorzagliatin, the world's first approved glucokinase activator (GKA) for Type 2 diabetes, was accepted by Hong Kong's Department of Health on September 29, 2025, positioning Hong Kong as a gateway for expansion into Southeast Asia and global markets.1 6

Dorzagliatin, marketed as HuaTangNing, was approved in China by NMPA in September 2022 for monotherapy in drug-naïve T2D patients and combination with metformin.1 2

In 2025 interim results, Hua Medicine reported doubled sales and profits, ongoing real-world BLOOM study with 2,000 patients in China confirming safety and efficacy, and plans for fixed-dose combination with metformin, with bioequivalence study expected in early 2026.2 5

Company strategy includes strengthening commercialization in China, registration in HK and Macau, partnerships in Southeast Asia, and development of 2nd generation GKA for obesity-related markets.3 2

CEO Dr. Li Chen emphasized Hong Kong's role in international expansion and dorzagliatin's potential in treatment and prevention of prediabetes.1