Hua Medicine Announces Approval of Dorzagliatin for Marketing in Hong Kong SAR
First glucokinase-activator (GKA) approval outside mainland China
Approval supports a differentiated approach to Type 2 diabetes (T2D) management
Hong Kong will serve as Hua Medicine’s launchpad for international market expansion
Under Hong Kong’s “1+” pharmaceutical regulatory innovation mechanism, the approval follows the acceptance of dorzagliatin’s New Drug Application (NDA) by the Hong Kong Department of Health in September 2025. As the first innovative drug for chronic metabolic diseases approved for marketing since the launch of “1+” mechanism, the successful rollout of dorzagliatin not only brings an entirely new treatment option for patients with Type 2 diabetes in Hong Kong, but also marks a crucial step in Hua Medicine’s strategic layout to expand from China to the Southeast Asian and global markets with Hong Kong as its hub.
Cao Beili, Vice President of Department of Corporate Operation and Great Bay Development of Hua Medicine, stated: “Among the three new drugs approved under the ‘1+’ mechanism, MYHOMSIS® is an innovative medicine developed in China that has obtained approval from the National Medical Products Administration (NMPA). It is also the first primary care drug product approved under the ‘1+’ mechanism.”
Dr. Chen Li, Founder, Executive Director and CEO of Hua Medicine, 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 launch in Hong Kong is a key step for Hua Medicine to enter the Southeast Asian and international markets. We will take Hong Kong as the hub to build a marketing network and R&D cooperation system radiating Southeast Asia and connecting the world, bringing China’s independently developed innovative drugs to more diabetes patients in countries and regions around the globe. Meanwhile, we will continue to advance the marketing approval process of dorzagliatin in the Macao Special Administrative Region of China to achieve its full rollout in the Guangdong-Hong Kong-Macao Greater Bay Area, and relying on the regional advantages in mechanisms, talent and medical resources, we will advance the clinical expansion of new indications and the international promotion of MYHOMSIS®.”
Global First-in-Class & Local Clinical Data: Establishing a New Model for Restoring Glycemic Homeostasis in Diabetes Treatment
Type 2 diabetes remains a progressive disease characterized by impaired glucose regulation and declining pancreatic β-cell function over time. While many therapies address downstream consequences of dysregulated blood glucose, dorzagliatin is a global first-in-class GKA innovative drug independently developed by Hua Medicine. Its core innovation lies in repairing the impaired function and expression of glucokinase (GK) in patients with Type 2 diabetes, thereby improving patients’ glucose sensitivity from the source and ameliorating the imbalance of glycemic homeostasis. The drug acts on multiple key organs of glucose metabolism including the islets, intestines and liver, exerting a synergistic effect through multiple targets:
enhancing glucose-stimulated insulin secretion from pancreatic β-cells,
promoting GLP-1 release from intestinal L-cells, and
modulating hepatic glucose output through glycogen regulation.
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：
It can be used as mono-therapy treatment for drug-naïve T2D patients, as first-line treatment,
When metformin hydrochloride alone exhibits poor blood glucose control in T2D patients, it can be used in combination with metformin hydrochloride.
Since January 1, 2024, dorzagliatin is included in China’s National Reimbursement Drug List and has been prescribed to over 200,000+ patients in mainland China already. In June last year, the interim analysis of real-world research presented at the Scientific Sessions of the American Diabetes Association (ADA) further verified its efficacy and safety in a broad population.
Leveraging Hong Kong’s “1+” Mechanism to Accelerate Access to Innovative Drugs for Hong Kong Residents
The formulation and implementation of Hong Kong’s “1+” pharmaceutical regulatory innovation mechanism is an important measure taken by the Hong Kong SAR Government to enhance the accessibility of medical innovation and attract high-quality global innovative drugs to launch in Hong Kong. This mechanism allows innovative drugs already approved in designated major markets (such as China, the United States, Europe, etc.) to secure marketing approval in Hong Kong through a simplified application pathway and data mutual recognition mechanism, which greatly shortens the time cycle from R&D to clinical access of innovative drugs for Hong Kong patients, while ensuring the safety and efficacy of the drugs.
With its local clinical data, clear therapeutic value and good safety record in China, dorzagliatin has become one of the first original Chinese innovative drugs to be rapidly approved through Hong Kong’s “1+” mechanism. This approval is an important practical achievement of the mechanism in enabling the launch of global innovative drugs in Hong Kong, which not only reflects the high recognition of the clinical value of dorzagliatin by the Department of Health of Hong Kong, but also highlights the core role of the “1+” mechanism in connecting the Chinese market and international pharmaceutical markets and accelerating the flow of innovative medical resources.
Building on Hong Kong’s Experience to Empower Global Diabetes Management
Diabetes is a major challenge for global public health. According to the 2025 G