• 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

SHANGHAI and HONG KONG, March 3, 2026 /PRNewswire/ -- Hua Medicine ("the Company", Hong Kong Stock Exchange Stock Code: 2552.HK) announced today that its global first-in-class glucokinase activator (GKA) dorzagliatin (Trade name: MYHOMSIS®, 華領片®) has been approved for marketing by the Pharmaceutical Service of the Department of Health of the Hong Kong Special Administrative Region of China for the treatment of Type 2 diabetes in adults.

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 dаta: 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.

This coordinated, multi-organ profile differentiates dorzagliatin from existing oral antidiabetic therapies and reflects Hua Medicine's focus on addressing glucose homeostasis dysregulation and controlling the progression of Type 2 diabetes and the occurrence of its complications from the source.

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-therapy treatment for drug-naive T2D patients, as first-line treatment,

2) 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 Global Diabetes Map released by the International Diabetes Federation (IDF), the number of adults aged 20-79 with diabetes worldwide reached 589 million in 2024, and this figure is projected to rise to 853 million by 2050.  In Hong Kong, China, diabetes is also a prominent public health issue. According to the Population Health Survey 2020-2022 conducted by the Department of Health of Hong Kong, 6.9% of people aged 15 or above reported having been diagnosed with diabetes by a doctor, and an additional 1.8% had hyperglycemia without being diagnosed with diabetes. In 2022, more than 600 death registrations in Hong Kong were attributed to diabetes, ranking 11th among the leading causes of death.^[1]

Hong Kong has accumulated rich experience in diabetes management, forming a comprehensive system covering disease surveillance, prevention, screening, treatment and community management, and its community-based public-private partnership model for diabetes management has achieved remarkable results. Following its launch in Hong Kong, dorzagliatin is expected to be deeply integrated with the local mature diabetes management system, and help improve patients' quality of life, control disease progression and reduce medical burdens through personalized treatment plans.

At present, Hua Medicine is collaborating with the research team led by Professor Juliana Chan, a world-renowned endocrinologist from the Chinese University of Hong Kong, to conduct the SENSITIZE series of studies to further explore the mechanism by which dorzagliatin improves pancreatic β-cell glucose sensitivity. The published results of the SENSITIZE 1/2 studies have shown that dorzagliatin can significantly improve the second-phase insulin secretion and β-cell glucose sensitivity in patients with glucokinase monogenic diabetes (GCK-MODY or MODY-2), and enhance basal insulin secretion in patients with newly diagnosed type 2 diabetes. In addition, dorzagliatin can also significantly improve the second-phase insulin secretion and β-cell glucose sensitivity in populations with impaired glucose tolerance (IGT).

Hua Medicine will continue to deepen cooperation with top local research institutions and clinicians to further explore the potential of dorzagliatin in pre-diabetes intervention, early treatment and complication prevention, accumulate additional international clinical data, lay a solid foundation for the expansion of its indications and global market promotion, and establish personalized intervention and treatment management plans for patients with pre-diabetes and Type 2 diabetes.

As a core hub of the Asian pharmaceutical market, Hong Kong, with its unique geographical location, advanced medical infrastructure, international business environment and close linkage with the Southeast Asian market, is expected to become the strategic starting point for Hua Medicine to expand into Southeast Asia and the global market. Relying on Hong Kong's advantage of pharmaceutical regulatory standards aligned with international norms and leveraging its financial and capital market strengths, Hua Medicine will further advance the registration and application of dorzagliatin in the Southeast Asian market to quickly cover the large population of diabetes patients in the region. Meanwhile, the Company will deepen cooperation with partners in the global pharmaceutical industry chain to accelerate the international commercialization of dorzagliatin.

Forward-Looking Statements

This document contains statements regarding Hua Medicine's and its products' future expectations, plans and prospects. Such forward-looking statements relate only to events or information as of the date on which the statements are made in this document and are subject to change in light of future developments. Except as required by law, the Company shall not be obligated to update or publicly revise any forward-looking statements or unforeseen events after the date of such statements, whether as a result of new information, future events or other circumstances. Please read this document carefully and understand that actual future performance or results of the Company may differ materially from expectations due to various risks, uncertainties or other statutory 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. In February 2026, dorzagliatin (Trade name: MYHOMSIS®, 華領片®) was approved for marketing by the Pharmaceutical Services of the Department of Health of the Government of the Hong Kong Special Administrative Region of China.

For more information

Hua Medicine

Website: www.huamedicine.com 

[1] https://www.chp.gov.hk/sc/features/37474.html

 

Source: Hua Medicine Related Stocks: HongKong:2552