By Fineline Cube 
Hua Medicine (HKG: 2552) announced that the Pharmaceutical Administration Bureau of the Macau Special Administrative Region has granted marketing approval for dorzagliatin (Macau trade name: MYHOMSIS), an oral therapy for adults with type 2 diabetes. This marks the final regulatory milestone in the company’s Greater China commercial strategy, following earlier approvals in mainland China (September 2022) and Hong Kong (February 2026).
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | Pharmaceutical Administration Bureau, Macau SAR |
| Approval Type | Full marketing authorization |
| Product | Dorzagliatin (MYHOMSIS in Macau) |
| Indication | Treatment of type 2 diabetes in adults |
| Approval Date | 30 Jun 2026 |
| Greater China Status | Approved in all three territories (Mainland China, Hong Kong, Macau) |
Drug Profile & Mechanism of Action
- Molecule: Global first-in-class allosteric glucokinase full activator
- Target: Glucokinase (GK), the body’s primary glucose sensor
- Innovation: Repairs impaired GK function and expression in type 2 diabetes patients, addressing the disease at its metabolic source rather than merely managing symptoms
- Intellectual Property: Independently developed by Hua Medicine with global patent protection
Dorzagliatin acts through a unique multi-organ mechanism:
- Pancreas: Promotes glucose-stimulated insulin secretion from beta cells
- Intestines: Enhances glucagon-like peptide-1 (GLP-1) secretion from L cells
- Liver: Regulates hepatic glucose output by modulating glycogen metabolism
This synergistic approach simultaneously improves beta-cell function, reduces insulin resistance, and restores glucose homeostasis regulation.
Commercial Positioning
| Milestone | Date | Strategic Impact |
|---|---|---|
| NMPA Approval (Mainland China) | Sep 2022 | Initial market access in world’s largest diabetes market |
| NRDL Inclusion | 2024 | Enhanced reimbursement and patient affordability |
| Hong Kong Approval | Feb 2026 | Expanded Greater China footprint |
| Macau Approval | Jun 2026 | Complete Greater China commercial coverage |
China represents approximately 25% of the global type 2 diabetes population, with an estimated 140 million adults affected. The inclusion of dorzagliatin in China’s National Reimbursement Drug List (NRDL) in 2024 significantly improved market access and positioned the drug favorably against competing therapies.
Market Impact & Outlook
- Diabetes Landscape: With rising prevalence and significant unmet needs in glucose control, first-in-class mechanisms like dorzagliatin offer differentiated therapeutic value
- Commercial Strategy: Hua Medicine now controls a unified Greater China commercial platform for its flagship product, enabling coordinated marketing and distribution
- Competitive Edge: Unlike conventional diabetes medications that target single pathways, dorzagliatin’s multi-organ glucose-sensing restoration represents a paradigm shift in treatment approach
- Global Potential: While currently focused on Greater China, the novel mechanism may support future international expansion pending additional clinical data
Forward-Looking Statements
This brief contains forward-looking statements regarding commercial expectations for dorzagliatin. Actual results may differ due to risks including market adoption rates, competitive dynamics, and healthcare policy changes.-Fineline Info & Tech