- Hong Kong Department of Health accepts NDA for dorzagliatin, the world’s first approved glucokinase activator (GKA).
- Builds on China approval and strong Phase III and real-world clinical results showing durable glucose control and safety.
- Positions Hong Kong as a strategic gateway for Hua Medicine’s global expansion into Southeast Asia and beyond.
SHANGHAI, Sept 29, 2025 – (ACN Newswire via SeaPRwire.com) – Hua Medicine (“the Company”, HKEX: 2552) announced that the Department of Health of the Hong Kong Special Administrative Region of China accepted a New Drug Application (NDA) for dorzagliatin, the world’s first glucokinase activator (GKA) approved for the treatment of Type 2 diabetes (T2D).
The acceptance of the NDA marks an important milestone in Hua Medicine’s strategy to expand beyond China, bringing its innovative, disease-modifying treatment to more patients across Asia and ultimately to global markets.
With more than half a million people living with diabetes in Hong Kong and nearly 240 million across Asia, the NDA represents a significant step toward addressing one of the region’s most urgent health challenges.
A first-in-class therapy with global potential
Dorzagliatin was approved for marketing by the China National Medical Products Administration (NMPA) in September 2022 for two indications, both to improve blood glucose control for T2D patients, 1) It can be used as mono-treatment for drug-naïve T2D patients, as first-line treatment, 2) When metformin hydrochloride alone has poor blood glucose control, it can be used in combination with metformin hydrochloride. Unlike conventional drugs that manage symptoms, dorzagliatin targets the root cause of blood sugar dysregulation by repairing the function of glucokinase (GK), the body’s glucose sensor. By restoring glucose sensitivity, dorzagliatin helps maintain blood sugar balance and supports long-term disease management.
Results from two Phase III registration trials in China demonstrated that dorzagliatin significantly and sustainably lowered HbA1c levels, improved pancreatic β-cell function, and reduced insulin resistance, all while showing strong safety and tolerability. Findings are being further validated in ongoing real-world studies, of which some interim analysis and data were presented at the 2025 American Diabetes Association (ADA) Scientific Sessions.
Strategic gateway to new markets
Hong Kong has established a comprehensive, community-based system for diabetes management and serves as a medical and financial hub for the region. Research findings from the Hong Kong Diabetes and Obesity Research Institute at The Chinese University of Hong Kong indicate that the implementation of a community-based public-private collaboration model for diabetes management provided significant benefits to the community. The advanced experience in Hong Kong is of great significance for improving the quality of life of diabetes patients, controlling the progression of the disease, and reducing the burden on the healthcare system. Once approved in Hong Kong, it will also provide clinical application of dorzagliation for the personalized management of diabetes.
According to Hong Kong’s former new drug approval mechanism, applicants were required to submit to the authority new drug registration certificates issued by the drug regulatory agencies of two or more recognized countries, as well as other specified relevant documents, in order to support the approval and marketing of the product. Under the newly established “1+” mechanism, after meeting requirements such as local clinical data support and having the applicable scope of the new drug endorsed by local experts, an applicant only needs to submit the approval from one (instead of the original two) reference drug regulatory authority to apply for registration of the new drug in Hong Kong. This mechanism initially applied to new drugs for the treatment of serious or rare diseases, and has been extended to all new drugs since 2024.Under the leadership of Ms. Beili Cao, Vice President of Department of Corporate Operation and Great Bay Development, Hua Medicine has conducted sufficient and in-depth communications with local clinical experts and regulatory authorities in Hong Kong, and became an early pioneer of this mechanism. The Company filed its application for registration of dorzagliatin in Hong Kong at the end of July, and the application was officially accepted by the end of September.
Dr. Li Chen, Founder and Chief Executive Officer of Hua Medicine, said: “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. We are committed to working with local doctors and partners in Hong Kong to explore dorzagliatin’s potential in both treatment and prevention of prediabetes and early-stage diabetes, ensuring more patients worldwide can benefit from this breakthrough therapy.”
Dorzagliatin: A transformative T2D treatment
Dorzagliatin was approved in September 2022 in China, and it was included in the country’s National Reimbursement Drug List (NRDL) as of January 1, 2024.
Dorzagliatin can be used alone as a first-line therapy for newly diagnosed patients, or together with metformin when blood sugar control is inadequate. Unlike many other approved oral antidiabetes drugs, no dose adjustment is required for patients with kidney impairment. It works by repairing the body’s glucose sensor, glucokinase (GK), restoring glucose sensitivity and long-term blood sugar balance. It acts across key organs—stimulating insulin secretion in the pancreas, boosting GLP-1 secretion in the gut, and regulating glycogen in the liver. This multi-target approach addresses the root cause of Type 2 diabetes, not just its symptoms.
The NDA application in Hong Kong is based on the results of two Phase III registration clinical studies conducted in China evaluating the use of dorzagliatin monotherapy and in combination with metformin for the treatment of patients with Type 2 diabetes. Two studies have shown that for two categories of T2D patients—those newly diagnosed and not yet on medication, and those who have failed to respond adequately to metformin therapy— dorzagliatin can sustainably and effectively lower patients’ HbA1c levels by repairing defects in the glucose sensor function of GK, significantly reduce postprandial two-hour blood glucose levels (2h-PPG), achieve high glycemic control rates without hypoglycemia, demonstrate good safety and tolerability, and continuously improve β-cell function and reduce insulin resistance.
Forward-Looking Statements
This document contains statements regarding Hua Medicine’s future expectations, plans, and prospects for the Company and its products. These forward-looking statements pertain only to events or information as of the date they are made and may change due to future developments. Unless required by law, we are not obligated to update or publicly revise any forward-looking statements or unexpected events after the date of such statements, regardless of new information, future events, or other circumstances. Please read this document carefully and understand that our actual future performance or results may differ materially from expectations due to various risks, uncertainties, or other legal requirements.
About Hua Medicine
Hua Medicine (The “Company”) is an innovative drug development and commercialization company based in Shanghai, China, with companies in the United States and Hong Kong. Hua Medicine focuses on developing novel therapies for patients with unmet medical needs worldwide. Based on global resources, Hua Medicine teams up with global high-calibre people to develop breakthrough technologies and products, which contribute to innovation in diabetes care. Hua Medicine’s cornerstone product HuaTangNing (dorzagliatin tablets), targets the glucose sensor glucokinase, restores glucose sensitivity in T2D patients, and stabilizes imbalances in blood glucose levels in patients. HuaTangNing was approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin for adult T2D patients. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral hypoglycemic drug that can be used for patients with Type 2 diabetes with renal function impairment.
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