[NEWS] Hua Medicine's Dorzagliatin Approved for Type 2 Diabetes Treatment in Macao SAR, China

June 30, 2026 – Shanghai, China and Macao SAR

Hua Medicine ("the Company", Hong Kong Stock Exchange Stock Code: 2552) announced today that its global first-in-class glucokinase activator (GKA) dorzagliatin (trade name in Macao: MYHOMSIS®, 華領片®) has been approved for marketing by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region for the treatment of Type 2 diabetes in adults.

Dorzagliatin is the first GKA approved for marketing in Macao. To date, it has been approved in China, Hong Kong and Macao. The successful approval in Macao not only expands the treatment options available to T2D patients but also marks a key step for Hua Medicine to leverage Macao’s unique advantages as a hub for China and Portuguese-speaking countries and expand to the global market.

Beili Cao, Vice President of Corporate Operations and Great Bay Development at Hua Medicine, said: "The approval of dorzagliatin in Macao as the first T2D first-in-class drug approved in all three regions of China, Hong Kong and Macao fully demonstrates the efficient and supportive review and approval process for innovative drugs in Macao. This is an important step forward for the Company in promoting collaborative pharmaceutical innovation development in the Guangdong-Hong Kong-Macao Greater Bay Area and enhancing the regional accessibility of innovative medicine developed in China."

Dr. Li Chen, Founder and CEO of Hua Medicine, said: "Benefiting from Macao’s continuously improving approval mechanism for innovative drugs and the strong support of the Macao SAR Government for pharmaceutical innovation, dorzagliatin has been successfully approved in Macao. This is not only a critical step for the Company to enter Portuguese‑speaking countries and the global market, but also validation of the strong competitiveness of China's self-developed innovative drugs."

Looking ahead, we will take Macao as an important launchpad, fully utilize its unique position as a commercial and trade cooperation service platform between China and Portuguese‑speaking countries, and build a marketing network and R&D collaboration system that expands to Portuguese‑speaking countries and connects the global market, bringing China‑originated innovative drugs to diabetic patients in more countries and regions," Dr. Chen said.

Innovative Global First-in-Class GKA, Pioneering a New Approach to Glycemic Homeostasis Management

Dorzagliatin is a global first-in-class allosteric glucokinase activator independently developed by Hua Medicine. Its core mechanism 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, enhancing β-cell function, reducing insulin resistance, and restoring glycemic homeostasis regulation. The drug acts on multiple key organs of glucose metabolism including the islets, intestines and liver, exerting a synergistic effect through multiple targets to enhance glucose-stimulated insulin secretion from pancreatic β-cells, promote GLP-1 release from intestinal L-cells, and modulate hepatic glucose output through glycogen regulation.

Dorzagliatin was approved for marketing by the China National Medical Products Administration (NMPA) in September 2022 for the treatment of Type 2 diabetes in adults, and was included in China’s National Reimbursement Drug List in 2024. In February 2026, dorzagliatin was approved for marketing by the Pharmaceutical Service of the Department of Health of the Hong Kong Special Administrative Region of China, becoming the first primary care drug product approved under the new "1+" pharmaceutical regulatory innovation mechanism of Hong Kong. Since its launch in China, dorzagliatin has benefited over 500,000 patients through over 3,000 hospitals, community health centers, pharmacies and online channels.

Leveraging Macao's Momentum to Build a New Paradigm for Global Diabetes Management

Diabetes has become a major health challenge for Macao residents. There were approximately 44,000 registered diabetes patients in Macao in 2024, according to statistics from the Macao Health Bureau. That number represented an increase of 13,000 or 45% compared with 2018. Nearly 90% of these patients require follow-up diagnosis and treatment by public healthcare institutions, placing considerable pressure on the healthcare system and turning diabetes into an increasingly serious public health issue.

The "Healthy Macao Blueprint” issued in 2024 aims to comprehensively improve the awareness, treatment and control of chronic diseases among residents by 2030, and effectively reduce the risk of death from chronic diseases. Following its launch, dorzagliatin is expected to be deeply integrated into Macao’s local diabetes health management system, thereby enhancing the treatment and control rates of diabetes through customized treatment plans and contributing to the establishment of a high‑quality diabetes management system for the Macao population.

Hua Medicine will continue to deepen its strategic cooperation with top-tier global research institutions and clinicians to further explore the clinical potential of dorzagliatin in pre-diabetes intervention, early treatment, combination therapies and complication prevention, and actively explore new indications in diabetes prevention, MODY2, mild cognitive impairment and frailty. By accumulating rich and high-quality international clinical data, the Company will provide strong evidence-based support for the expansion of indications and commercialization of dorzagliatin worldwide.

Looking ahead, capitalizing on the strategic positioning of Macao as a commercial and trade cooperation service platform between China and Portuguese-speaking countries, Hua Medicine will continue to explore regulatory filing and commercialization pathways in Portuguese-speaking countries, covering the large diabetic populations in regions such as Brazil. The Company aims to build a three-dimensional market coverage network that is rooted in China and faces Southeast Asia and Portuguese-speaking countries, bringing China-originated innovative diabetes treatment solutions to patients worldwide.

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 30, 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 Service of the Department of Health of the Government of the Hong Kong Special Administrative Region of China. In June, dorzagliatin (trade name: MYHOMSIS®, 華領片®) was approved for marketing by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region of China.

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Nothing in this content constitutes a recommendation, promotion, or medical advice regarding any pharmaceutical product. References to efficacy, safety, or therapeutic potential relate strictly to data presented at the meeting and do not imply regulatory approval for any unapproved indications.