By Fineline Cube 
China‑based Hua Medicine (HKG: 2552) announced that the Hong Kong Department of Health has accepted its New Drug Application (NDA) for dorzagliatin, the world’s first approved glucokinase activator (GKA) for type 2 diabetes (T2D).
What Sets Dorzagliatin Apart
- First‑of‑Its‑Kind GKA – Dorzagliatin repairs the body’s glucose‑sensor, glucokinase (GK), tackling the root cause of hyperglycaemia rather than merely masking symptoms.
- Dual‑Indication Profile – Approved by China’s NMPA in 2022 for:
- Monotherapy in drug‑naïve T2D patients (first‑line therapy).
- Combination therapy with metformin when metformin alone is insufficient.
- Long‑Term Glycaemic Control – By restoring GK function, the drug sustains glucose sensitivity, supporting durable disease management and potentially reducing complications.
Strategic Significance for Hua Medicine
- Regional Expansion – The Hong Kong NDA acceptance marks a pivotal milestone in Hua Medicine’s strategy to extend beyond the mainland Chinese market, potentially delivering its innovative therapy to a wider Asian patient base.
- Regulatory Momentum – With approvals in China (2022) and now Hong Kong (2025), the company is building a solid regulatory foundation that could accelerate future approvals in other jurisdictions.
- Commercial Opportunity – T2D remains the fastest‑growing chronic disease worldwide; dorzagliatin’s first‑line and combination indications broaden its commercial footprint, positioning Hua Medicine for significant revenue growth.
Investor Outlook
- Pipeline Credibility – The first‑in‑class GKA platform and successful regulatory milestones enhance investor confidence in Hua Medicine’s innovation pipeline.
- Market Potential – The drug’s unique mechanism and broad indication set it apart from traditional anti‑diabetic therapies, potentially capturing a sizeable share of the high‑growth diabetes therapeutics market.-Fineline Info & Tech