The Hong Kong Department of Health has accepted a New Drug Application (NDA) for dorzagliatin, marking a significant regulatory milestone for Hua Medicine's groundbreaking Type 2 diabetes treatment. The drug represents the world's first approved glucokinase activator (GKA), offering a novel mechanism of action that targets the underlying pathophysiology of diabetes rather than merely managing symptoms.
The NDA acceptance positions Hong Kong as a strategic gateway for Hua Medicine's international expansion, with the potential to serve more than half a million diabetes patients in Hong Kong and nearly 240 million across Asia. This regulatory step builds on dorzagliatin's established success in China, where it received approval from the National Medical Products Administration (NMPA) in September 2022.
Novel Mechanism Addresses Root Cause of Diabetes
Unlike conventional antidiabetic medications that primarily manage symptoms, dorzagliatin works by repairing the function of glucokinase (GK), the body's glucose sensor. This innovative approach restores glucose sensitivity and helps maintain long-term blood sugar balance through a multi-organ mechanism of action.
The drug stimulates insulin secretion in the pancreas, boosts GLP-1 secretion in the gut, and regulates glycogen in the liver. This comprehensive approach addresses the fundamental glucose sensing defects that characterize Type 2 diabetes, offering patients a disease-modifying treatment option.
Dorzagliatin is approved for two key indications: as monotherapy for drug-naïve T2D patients as first-line treatment, and in combination with metformin when metformin alone provides inadequate blood glucose control. Notably, no dose adjustment is required for patients with kidney impairment, distinguishing it from many other oral antidiabetic drugs.
Strong Clinical Evidence Supports Efficacy
The Hong Kong NDA is supported by results from two Phase III registration trials conducted in China, which demonstrated dorzagliatin's ability to significantly and sustainably lower HbA1c levels while improving pancreatic β-cell function and reducing insulin resistance. The studies showed strong safety and tolerability profiles across patient populations.
Clinical data revealed that dorzagliatin effectively reduced postprandial two-hour blood glucose levels (2h-PPG) and achieved high glycemic control rates without hypoglycemia in both newly diagnosed patients and those who had failed to respond adequately to metformin therapy. The drug's efficacy is being further validated through ongoing real-world studies, with interim analyses presented at the 2025 American Diabetes Association (ADA) Scientific Sessions.
Strategic Regulatory Pathway
Hua Medicine leveraged Hong Kong's newly established "1+" mechanism for drug approval, which allows applicants to submit approval from one reference regulatory authority instead of the previously required two. This streamlined pathway, initially designed for serious or rare diseases and extended to all new drugs in 2024, enabled faster regulatory processing.
Under the leadership of Ms. Beili Cao, Vice President of Department of Corporate Operation and Great Bay Development, Hua Medicine conducted extensive communications with local clinical experts and regulatory authorities. The company filed its registration application at the end of July 2025, with official acceptance by the end of September.
Market Access and Commercial Success
Dorzagliatin has already demonstrated commercial viability in China, where it was included in the National Reimbursement Drug List (NRDL) effective January 1, 2024. This inclusion significantly expanded patient access to the innovative therapy and validated its clinical and economic value within China's healthcare system.
Dr. Li Chen, Founder and Chief Executive Officer of Hua Medicine, emphasized the strategic importance of the Hong Kong approval: "Acceptance of dorzagliatin's NDA in Hong Kong is not only recognition of its clinical value but also a pivotal step in Hua Medicine's international journey. Hong Kong's unique position as a regional healthcare leader and financial hub makes it the ideal gateway for expanding dorzagliatin's reach into Southeast Asia and beyond."
Addressing Regional Healthcare Needs
Hong Kong's comprehensive, community-based diabetes management system positions it as an ideal testing ground for dorzagliatin's broader clinical applications. Research from the Hong Kong Diabetes and Obesity Research Institute at The Chinese University of Hong Kong has demonstrated that community-based public-private collaboration models for diabetes management provide significant benefits to patients and healthcare systems.
The company plans to work with local doctors and partners in Hong Kong to explore dorzagliatin's potential in both treatment and prevention of prediabetes and early-stage diabetes, potentially expanding its therapeutic applications beyond current indications.
This regulatory acceptance represents a crucial step in bringing innovative diabetes care to a region facing significant disease burden, with the potential to improve outcomes for millions of patients across Asia while establishing a foundation for global market expansion.
