-  Expanded manufacturing scale lifted gross profit margin substantially to 61.8%, a year-on-year rise of 7.6 percentage points.

-  Profit generated from commercial operations doubled year-on-year, and loss narrowed markedly to RMB30.2 million after excluding one-off income, demonstrating a clear path to full-scale profitability.

-  Selling expense-to-revenue ratio stabilized at 33.5%, reflecting tangible gains from increased marketing efforts and streamlined operations.

-  Dorzagliatin secured marketing approvals in both the Hong Kong and Macao Special Administrative Regions of China; demonstrating our innovative business model is showing early success and marking a key milestone for global expansion.

-  A five-year patent term extension was granted for dorzagliatin, extending core patent protection to April 2034. The National Reimbursement Drug List price of the product will remain unchanged for 2026 and 2027, reinforcing long-term commercial profitability certainty.

-  Topline results from real-world studies further validated the broad applicability, safety and tolerability of dorzagliatin across diverse real-world patient populations.

-  Multiple combination therapy studies revealed synergistic metabolic benefits when dorzagliatin is paired with oral small-molecule GLP-1 receptor agonists, THR-β agonists and pan-PPAR agonists, tapping into development therapeutic potential in new disease areas including obesity and MASLD.

-  Clinical development of the second-generation GKA in the United States proceeded smoothly. R&D initiatives for new indications including MODY-2, diabetes prevention, neurodegenerative diseases and frailty were accelerated across the board.

SHANGHAI, August 20, 2026 - (ACN Newswire) - Hua Medicine (the “Company”, HKEx: 2552) announced the unaudited consolidated results of the Company and its subsidiaries for the six months ended June 30, 2026 (the “Reporting Period”), as well as the Company's business progress during the first half of the year and future outlook. During the Reporting Period, HuaTangNing, dorzagliatin tablets), the Company’s core globally first-in-class oral anti-diabetic glucokinase activator (GKA), entered a rapid scale-up phase under proprietary commercialization. Revenue and gross profit both recorded substantial growth with sustained gross margin improvement. The Company achieved critical milestones in global expansion through the commercial launch of dorzagliatin in Hong Kong and Macao SARs. Multiple pivotal clinical datasets were presented at leading international academic conferences, delivering continuous breakthroughs across the full product pipeline. Core operating losses narrowed steadily, while robust cash reserves laid a solid foundation for the Group’s long-term sustainable growth.

Dr. Li Chen, Founder and CEO of Hua Medicine, stated: “The first half of 2026 represents a pivotal stage for Hua Medicine as we translate original innovation into marketing value realization. Sales volume and revenue of dorzagliatin grew more than 70% year-on-year, gross margin surpassed 60%, and profit from commercial operations doubled compared with the same period last year. It validates the Company’s successful transition from R&D-innovation-driven growth to rapid commercial development in the chronic disease space. It fully demonstrates that domestically developed first-in-class drugs from China possess strong and sustainable market momentum, backed by national policies that support innovative drugs across the full-value chain. Meanwhile, dorzagliatin was successfully launched in Hong Kong and Macao SARs, officially kicking off our internationalization strategy anchored in Greater China with outreach to Southeast Asian, Spanish-speaking and Portuguese-speaking markets. Chinese original innovative medicines are now deeply participating in the global metabolic disease treatment landscape. Moving forward, rooted in glycemic homeostasis regulation, the Company will advance a new paradigm for diabetes homeostasis-targeted therapy featuring next-generation long-acting GKAs, fixed-dose combinations and combination therapies. We will build a human energy-metabolism health pipeline matrix covering disease prevention, special types of diabetes, fatty liver diseases and steatohepatitis, cognitive impairment and frailty. Leveraging artificial intelligence technologies, the Company will continuously expand the clinical boundaries and application scenarios of its glycemic homeostasis technology platform, and strive to bring China-originated innovative therapies to patients with metabolic diseases at home and abroad.”

Business Highlights and Operational Progress

1. Accelerated Proprietary Commercialization with Major Operational Efficiency Improvements

- Rapid sales expansion. During the Reporting Period, we sold approximately 3,055,000 packs of HuaTangNing in the first half of 2026, up 73% from 1,764,000 packs sold during the same period in 2025. This rapid sales growth trajectory is further supported by the maintenance of China’s National Reimbursement Drug List (NRDL) price for the 2026 and 2027 calendar years. Regions that already led sales in 2025, coastal areas including Shanghai, Tianjin and Guangdong province and Beijing, continued to deliver strong growth during the reporting period, reflecting the substantial market potential for further market penetration and providing a solid basis for sustained strong growth in the future.

- Markedly enhanced profitability driven by scale effects. Relying on expanded production capacity and optimized manufacturing processes, gross margin rose significantly from 54.2% in the first half of 2025 to 61.8%, up 7.6 percentage points; gross profit reached RMB234.3 million, a 99% year-on-year surge. Selling expenses totalled RMB126.9 million, with the ratio of selling expense to revenue standing at 33.5%. Our commercialization efforts achieved profit of approximately RMB107.4 million (as defined by gross profits less selling expenses), doubled from RMB53.7 million in the same period of 2025. as profitability from proprietary commercialization continues to materialize.

- Normalized financial performance with healthy cash reserves. Loss before tax stood at approximately RMB30.2 million. Excluding the one-off release of contract liabilities in the corresponding period of 2025 following the termination of the Bayer contract, the loss for the current reporting period is expected to narrow by approximately RMB29.4 million as compared with the adjusted loss of approximately RMB59.6 million for the corresponding period in 2025. Fundamental business operations continued to improve. Cash balances were approximately RMB1,072.9 million as of June 30, 2026 a decrease of RMB19.4 million from bank balances and cash position as of December 31, 2025. Ample liquidity supports domestic market expansion, global clinical R&D, and overseas commercialization in Hong Kong, Macao and Southeast Asia.

- Our commercialization team continued to scale. The professional sales team expanded to 187 product representatives, and 75 staff actively engaged in marketing, medical affairs and commercial operation as of June 30, 2026, representing growth of 93% and 79% respectively compared with the same period of 2025.

2. Strengthened Core Intellectual Property Rights and Breakthroughs in Overseas Market Development

- Marketing approvals secured and commercialization rolled out in Hong Kong and Macao. Dorzagliatin (brand names: MYHOMSIS(R) was approved for marketing in Hong Kong on February 2026 and in Macao on June 2026. The product has been distributed to hospitals and pharmacies in Hong Kong, with the first prescription issued in August 2026, providing a new treatment option for patients with Type 2 diabetes outside mainland China. 

- Patent term extension secured to boost long-term commercial certainty. In February 2026, the China National Intellectual Property Administration granted a five year patent term extension for dorzagliatin, extending core patent protection to April 2034.

3. Real-World Clinical Evidence Reinforces the Product’s Differentiated Value

The Group continued advancing post-marketing real-world studies of dorzagliatin to further validate its efficacy and safety profiles in complex patient cohorts.

- Topline data released from large-scale multi-centre post-marketing real-world study HMM0601. At the 2026 ADA Scientific Sessions, the Company presented results from HMM0601, a large-scale post-marketing real-world study. Across 80 clinical centres in China, HMM0601 enrolled 2024 patients with Type 2 diabetes with mean disease duration of 7.9 years. Over the 52-week treatment period, no drug-related serious adverse events (SAEs) or episodes of severe hypoglycemia were observed; the incidence of clinically meaningful hypoglycemia was below 1%, and no new safety signals were identified compared with the Phase III clinical trials; HbA1c was significantly reduced from baseline, and the proportion of patients achieving HbA1c<7% increased markedly. This provides robust evidence of dorzagliatin’s strong safety and tolerability profile and consistent glycemic control efficacy.

- Interim findings disclosed from prospective real-world observational study HMM0701. This study enrolled 255 patients with Type 2 diabetes, the majority of whom had long disease duration and were already receiving multi-drug regimens including insulin. The 6-month interim results of subgroup analysis indicates that dorzagliatin provides meaningful efficacy in glycemic control. Even in patients with severely compromised baseline TIR, clinically meaningful reductions in HbA1c, improved TIR, enhanced β-cell function, and reduced insulin resistance were observed, collectively indicating the restoration of glucose homeostasis. This study provides a solid rationale for a novel glycemic management option in complex T2D cases.

- Preparations remain underway for post-marketing study HMM0602. The study is designed to generate further clinical evidence regarding the role of dorzagliatin in restoring glucose homeostasis and its potential contribution to diabetes remission.

Research and Development Pipeline and Future Outlook

1. Multiple R&D Innovation Breakthroughs Usher in New Chapters for First-in-Disease Indications

- Dorzagliatin for Patients with GCK-MODY

Medical experts in mainland China and Hong Kong have conducted independent clinical and preclinical studies of dorzagliatin for MODY-2 treatment. MODY-2, also called GCK-MODY, is a monogenic disease in which patients have a genetic defect of glucokinase gene (GCK) which results in elevated blood glucose and significant reduction of the second phase release of insulin. The population of GCK-MODY patients is approximately 1.7 million in China. These patients are diagnosed with diabetes at a young age and represent an unmet medical need given currently available medications are not effective. In clinical studies with MODY-2 patients, a single dose of dorzagliatin improved overall glucose sensitivity and second phase insulin secretion significantly in GCK-MODY patients, suggesting a unique mechanism of action of dorzagliatin to regulate glucagon like peptide 1 (GLP-1) secretion. During the Reporting Period, we continued to advance the regulatory development of dorzagliatin for GCK-MODY in China. Following prior communications with the Center for Drug Evaluation of the National Medical Products Administration, we completed the proposed clinical protocol. We plan to submit an IND application for dorzagliatin in GCK-MODY by December 2026.

- Dorzagliatin for Diabetes Prevention

Prevention of diabetes is an important focus at Hua Medicine. There are approximately 1.12 billion people living with prediabetes worldwide. We have initiated the SENSITIZE 3 clinical study in Hong Kong in pre-diabetic (IGT) subjects and in early diabetes patients under the leadership of Dr Juliana Chan and Dr Elaine Chow of the Chinese University of Hong Kong. These studies represent first-in-disease studies. In this double-blinded placebo-controlled study, we will evaluate the blood glucose management and pancreatic function under intravenous glucose tolerance test and oral glucose tolerance test conditions to better define the clinical treatment baseline and endpoints. We expect to complete this study in 2026 and file IND applications of dorzagliatin for diabetes prevention in China and Asia-Pacific regions thereafter.

- Dorzagliatin for Neurodegenerative Diseases

MCI shows approximately 15.5% prevalence among elderly people in China and approximately 22% in the United States, and is common in T2D patients with a 45% incidence rate. Development of dorzagliatin for neurodegenerative disease is a new focus in our drug discovery efforts. Through the Genome-Wide Association Study (GWAS) and Mendelian Randomization (MR) study, we have realized the important role of GCK gene activation in prevention of memory loss and cognitive impairment in humans. It has also come to our attention that post-meal glucose excursion is closely related to Alzheimer disease and dementia. Impaired glucose homeostasis and diabetes conditions result in a reduction of glucose transporter expression and insulin receptor expression in the brain, which can be prevented by low dose dorzagliatin. We have realized the potential of dorzagliatin in the treatment of MCI and are initiating these first-in-disease clinical studies. Preparation of the clinical study protocol and clinical development plan has been initiated. We expect to launch pre-IND communications with the relevant regulatory authority in the fourth quarter of 2026.

- Dorzagliatin for Frailty

Frailty is an age-related geriatric syndrome characterized by reduced tolerance to internal and external stressors. Approximately 17% of American older adults and 11% of Asian older adults suffer from frailty, while pre-frailty affects roughly 50% and 47% of these populations, respectively. It is not a single-organ disease, but the consequence of dysregulated multisystem homeostasis. Genetic evidence has suggested a potential relationship between glucokinase activation and a reduced risk of frailty, supporting further investigation of dorzagliatin in this area. We intend to progress the regulatory preparations for an IND submission in 2026.

2. Robust Pipeline Gains Momentum, AI Powers Collaborative Innovation

- Fixed Dose Combination of Dorzagliatin and Metformin

We are fast forwarding the development of the FDC of dorzagliatin with metformin. An IND with the NMPA has been filed for our FDC with metformin in China in 2025, with an NDA submission planned for 2027.

- The 2nd Generation of GKA under Development in the United States

HM1005 is our second-generation GKA program based on a sustained-release formulation of dorzagliatin and is being developed as a once-daily oral therapy. In 2025, we successfully initiated MAD clinical study in T2D patients in the United States. As of the date of this report, five cohorts have been completed as planned in the Phase Ib multiple ascending dose study. HM1005 was generally well tolerated across the completed cohorts. We are conducting a subsequent cohort evaluating two 246 mg tablets in the United States. Topline data are expected to be published in the second half of 2026, and we will pursue partnerships to develop the 2nd generation GKA for global markets.

- Development of Combination Therapies for Diabetes and Metabolic Diseases

We presented three combination therapy studies in animal models of metabolic disorder at 2026 ADA. The combination of dorzagliatin and orforglipron, an oral small-molecule GLP-1 receptor agonist, demonstrated synergistic glycemic control, significantly enhanced β-cell function, and maintained weight loss and lipid-lowering benefits in diet-induced obese (DIO) mice. Notably, the data revealed a compelling dose-sparing effect which directly reduces the overall side-effect burden – particularly common GLP-1-related gastrointestinal adverse events – thereby meaningfully improving long-term patient adherence. These complementary mechanisms across glycemic control, weight loss, and lipid improvement, position the potential combination as a highly effective, well-tolerated, and differentiated oral option for T2D patients with obesity. In the study combining dorzagliatin with the THR-β agonist resmetirom, the combination synergistically improved systemic metabolism and exerted hepatoprotective effects, optimizing glycemic control, regulating lipids, reducing uric acid, and alleviating hepatic fibrosis. This supports the clinical potential of dorzagliatin for T2D patients with MASLD. Additionally, the combination of dorzagliatin with chiglitazar, a pan-PPAR agonist, improves glucose tolerance, reduces insulin resistance, enhances insulin sensitivity and β-cell function, and elevates high-density lipoprotein cholesterol levels in DIO mice model of MASLD.

- Integration of AI, LLMs and Clinical Big Data

Alongside the continued development of dorzagliatin in research and clinical practice, the Company has continued to invest in the integration of AI, large language models (LLMs) and clinical big data, and has achieved concrete outcomes. We launched our proprietary GK education platform (GK Charger) in 2025. The platform uses natural language interaction to present complex glucokinase relevant knowledge in evidence-based, clinically relevant format that is easy for both physicians and patients to understand. It enables doctors to obtain up to date diagnostic and treatment information, make accurate clinical decisions, and develop individualized treatment plans for patients. Since the launch of GK Charger, the platform has cumulatively responded to more than 3,700 queries.

Financial Summary

As of June 30, 2026

- Sales volume of HuaTangNing reached approximately 3.055 million packs, up 73% year-on-year, generating revenue of approximately RMB378.9 million, representing a 74% year-on-year increase.

- Gross profit totalled approximately RMB234.3 million, up 99% year-on-year, with gross margin rising to 61.8%.

- Loss before tax stood at approximately RMB30.2 million, representing a substantial narrowing compared with adjusted loss recorded in the same period of 2025.

- Bank balances and cash position were approximately RMB1,072.9 million, maintaining a healthy liquidity profile.

- Total expenditures amounted to approximately RMB265.4 million, including selling expenses of approximately RMB126.9 million and research and development expenses of approximately RMB66.8 million.

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. Drawing on global resources, Hua Medicine partners with high-calibre talent worldwide to develop breakthrough technologies and products that advance innovation in diabetes care. Hua Medicine's cornerstone product HuaTangNing (dorzagliatin tablets) targets the glucose sensor glucokinase, restores glucose sensitivity in patients with type 2 diabetes (T2D), 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 patients with T2D. For patients with chronic kidney disease (CKD), no dose adjustment is required. It is an oral glucose-lowering drug that can be used in patients with T2D with renal function impairment.

In February 2026, dorzagliatin (brand name: MYHOMSIS(R), was approved for marketing by the Pharmaceutical Service of the Department of Health of the Government of the Hong Kong Special Administrative Region of the People's Republic of China.

In June 2026, dorzagliatin (brand name: MYHOMSIS(R), was approved for marketing by the Pharmaceutical Administration Bureau of the Macao Special Administrative Region of the People's Republic of China.

Based on the International Diabetes Federation’s 2025 Diabetes Atlas – 11th Edition, there are approximately 148 million diabetic patients in mainland China, 706,000 diabetic patients in Hong Kong SAR, and 52,000 diabetic patients in Macao SAR as of 2024.

For more information

Website: www.huamedicine.com

Investors Email: ir@huamedicine.com

Media Email: pr@huamedicine.com

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