Hua Medicine's First-in-Class Diabetes Drug Dorzagliatin Gains Hong Kong Approval, Marking International Expansion Milestone
核心洞察
Hua Medicine (搜索)'s dorzagliatin (MYHOMSIS (搜索)®) becomes the first glucokinase (搜索) activator approved outside mainland China, securing marketing authorization in Hong Kong for Type 2 diabetes (搜索) treatment.
The global first-in-class drug targets glucokinase (搜索) to restore glucose homeostasis through multi-organ action on pancreatic β-cells, intestinal L-cells, and liver metabolism.
Hong Kong approval leverages the "1+" regulatory mechanism and positions the company for Southeast Asian market expansion, with over 200,000 patients already treated in mainland China.
Hua Medicine (搜索) announced that its global first-in-class glucokinase (搜索) activator dorzagliatin (MYHOMSIS (搜索)®) has received marketing approval from Hong Kong's Department of Health for treating Type 2 diabetes (搜索) in adults. This marks the first glucokinase activator approval outside mainland China and represents a significant milestone in the company's international expansion strategy.
The approval follows acceptance of dorzagliatin's New Drug Application by Hong Kong's Department of Health in September 2025, making it the first innovative drug for chronic metabolic diseases approved under Hong Kong's "1+" pharmaceutical regulatory mechanism.
Novel Mechanism Addresses Glucose Homeostasis at Source
Dorzagliatin represents a paradigm shift in diabetes treatment by targeting the underlying glucose sensing mechanism rather than downstream consequences. The drug repairs impaired glucokinase (搜索) function and expression in Type 2 diabetes (搜索) patients, improving glucose sensitivity and restoring glycemic homeostasis balance.
The therapy acts on multiple key organs of glucose metabolism through coordinated mechanisms:
- Enhancing glucose-stimulated insulin secretion from pancreatic β-cells
- Promoting GLP-1 release from intestinal L-cells
- Modulating hepatic glucose output through glycogen regulation
This multi-organ profile differentiates dorzagliatin from existing oral antidiabetic therapies and reflects Hua Medicine (搜索)'s focus on controlling Type 2 diabetes (搜索) progression and complications from the source.
Established Clinical Track Record in China
Dorzagliatin received approval from China's National Medical Products Administration in September 2022 for two indications to improve blood glucose control in Type 2 diabetes (搜索) patients. The drug can be used as monotherapy for drug-naïve patients as first-line treatment, or in combination with metformin when metformin alone provides inadequate glucose control.
Since inclusion in China's National Reimbursement Drug List on January 1, 2024, dorzagliatin has been prescribed to over 200,000 patients in mainland China. Interim analysis of real-world research presented at the American Diabetes Association Scientific Sessions further verified its efficacy and safety in a broad population.
Hong Kong as Strategic Launch Platform
Dr. Chen Li, Founder, Executive Director and CEO of Hua Medicine (搜索), stated: "The approval of dorzagliatin for marketing in Hong Kong is a significant milestone in the Company's development. As one of the first original innovative drugs to benefit from Hong Kong's '1+' mechanism, this achievement not only reflects Hong Kong's support for innovative drugs, but also validates the global competitiveness of China's independently developed innovative drugs."
The company plans to use Hong Kong as a hub to build marketing networks and R&D cooperation systems radiating to Southeast Asia and connecting globally. Hua Medicine (搜索) will advance marketing approval processes in Macao to achieve full rollout in the Guangdong-Hong Kong-Macao Greater Bay Area.
Addressing Global Diabetes Burden
According to the 2025 Global Diabetes Map from the International Diabetes Federation (搜索), the number of adults aged 20-79 with diabetes worldwide reached 589 million in 2024, projected to rise to 853 million by 2050. In Hong Kong, the Population Health Survey 2020-2022 found 6.9% of people aged 15 or above reported diabetes diagnosis, with an additional 1.8% having hyperglycemia without diabetes diagnosis.
Ongoing Research Collaboration
Hua Medicine (搜索) collaborates with Professor Juliana Chan's research team at the Chinese University of Hong Kong on the SENSITIZE series of studies exploring dorzagliatin's mechanism for improving pancreatic β-cell glucose sensitivity. Published SENSITIZE 1/2 study results showed dorzagliatin significantly improved second-phase insulin secretion and β-cell glucose sensitivity in patients with glucokinase monogenic diabetes (搜索) and enhanced basal insulin secretion in newly diagnosed Type 2 diabetes (搜索) patients.
The drug also significantly improved second-phase insulin secretion and β-cell glucose sensitivity in populations with impaired glucose tolerance (搜索), supporting potential applications in pre-diabetes intervention and early treatment.
Cao Beili, Vice President of Department of Corporate Operation and Great Bay Development, noted: "Among the three new drugs approved under the '1+' mechanism, MYHOMSIS (搜索)® is an innovative medicine developed in China that has obtained approval from the National Medical Products Administration. It is also the first primary care drug product approved under the '1+' mechanism."