Hua Medicine Announces 2025 Annual Results

- Annual sales of HuaTangNing exceeded 4 million packs, a year-on-year increase of 91%, with revenues reaching RMB 492.9 million, a year-on-year increase of 93%, marking outstanding results from the Company’s fully independent commercialization operation.

- Delivered record financial performance, with profit before tax reaching RMB 1,106.4 million; maintained a robust bank balance and cash position of RMB 1,092.3 million at year-end, laying a solid foundation for sustainable operations and growth.

- Gross margins rose to 56.9%, and selling expenses as a percentage of revenue were optimized to 33.6% from 59.9%, significantly enhancing profitability.

- HuaTangNing  renewed its listing in the new National Reimbursement Drug List (NRDL) at the same price in 2025 for the calendar years 2026 and 2027, reaffirming its clinical and innovative value.

- With the approval of PTE, market exclusivity in China granted another 5 years to April 2034, further strengthening commercial certainty.

- Dorzagliatin was approved for commercialization in Hong Kong as HYHOMSIS®, accelerating its global expansion toward South-East Asia.

- Multiple real-world evidence published to demonstrate therapeutic advantage of dorzagliatin.

- Continuous expansion of therapeutic potential of glucose homeostasis and initiation of new first-in-disease indications study covering diabetes prevention, rare diseases, mild cognition impairment and frailty.

SHANGHAI, Mar 27, 2026 - (ACN Newswire) – Hua Medicine ("the Company", Hong Kong Stock Exchange Stock Code: 2552) announces the audited consolidated results of the Company and its subsidiaries for the year ended December 31, 2025 (the “Reporting Period”). During the Reporting Period, the commercialization of HuaTangNing (dorzagliatin tablets), the Company’s core product – the global first-in-class innovative anti-diabetes medicine, glucokinase activator (GKA) – advanced comprehensively across all fronts, the Company’s independent commercialization team was efficiently and seamlessly established in its first year of operations, the Company’s R&D pipeline continued to be enriched, and the Company’s financial performance achieved a historic breakthrough, successfully entering a new stage of profitability, injecting strong momentum into the innovative development of the global diabetes treatment field.

Dr. Li CHEN, Founder and CEO of Hua Medicine, stated: “2025 is a remarkable year in the commercialization operation of Hua Medicine. The Company has successfully advanced from R&D to commercialization driven organization and achieved the fully independent capacity in commercialization of global first in class novel glucose homeostasis regulator HuaTangNing. With strong market execution and product competitiveness, we have achieved nearly triple-digit growth in sales volume and revenue over 2024 when the commercialization was farmed out to sales and marketing partners. At the same time, the Company has made key progress in global market expansion through registration of drozagliatin in Hong Kong and position it toward 700 M population in south-east Asia. We continue to expand the clinical application of glucose homeostasis regulation technology and engage in new indications such as early-stage Alzheimer’s disease and Frailty. The first-in-disease efforts in GCK-MODY and Frailty set the new innovation course of Hua Medicine in the next 5 years.” 

Business Highlights and Operational Progress

- Fully Powered Commercialization, Historic Breakthrough in Profitability

On January 1, 2025, the Company assumed full responsibility for the commercialization of HuaTangNing, allowing the company to consolidate both operational and strategic control over market execution in China. The Company successfully built a professional sales team covering 10 sales regions around the country, focusing on marketing, medical affairs and commercial operation. Through an AI-empowered digital commercialization platform, operational efficiency and sales productivity were greatly enhanced, injecting new vitality into the Company’s commercial development.

Reimbursement coverage under the NRDL has significantly increased accessibility, especially in Tier 2 and Tier 3 hospitals, and played a critical role in accelerating patient adoption. Since its launch in October 2022, HuaTangNing has been prescribed to over 500,000 patients through 3,000+ hospitals, community centers, pharmacies and online channels.

Sales performance exceeded expectations, with 4.011 million packs of HuaTangNing sold during the reporting period, representing a 91% increase over the fiscal year 2024. This growth was achieved at the same price for both periods, underscoring strong demand and successful execution of Hua’s commercial strategy.

In terms of profitability, the Company’s gross profit reached approximately RMB280.4 million, a year-on-year increase of 125%. Thanks to expanded production scale and optimized manufacturing processes, the Company’s gross margin improved to 56.9%,  increasing by 8.2 percentage points as compared to 48.7% for the year of 2024. Selling expenses increased only by RMB12.3 million to RMB165.5 million, reflecting a significant positive trend towards profitability when our selling expenses in the 2025 fiscal year represents only 33.6% of revenue, whereas in the 2024 fiscal year, our selling expenses represented approximately 59.9% of revenue. In fiscal year 2025, our commercialization efforts achieved profits of approximately RMB114.9 million (as defined by gross profits less selling expenses). Although we expect to continue to increase personnel to our commercialization team, we expect this profitability trend in our commercial operations in mainland China to continue.

Following the termination of the collaboration with Bayer at the end of 2024, dorzagliatin achieved a record-high sales volume. Profit before tax increased to RMB1,106.4 million for the fiscal year 2025. We ended fiscal year 2025 with a cash position of approximately RMB1,092.3 million.

- Accelerated Global Layout, Strengthened Core Rights and Interests

The Company took a key step in global expansion. On February 27, 2026, dorzagliatin (trade name: MYHOMSIS®, was successfully approved for marketing by the Hong Kong regulatory authority. The Company plans to officially launch the product in the Hong Kong market by the middle of 2026 and further expand to Asian regions. In addition, the Company submitted a new drug registration application in Macau in 2025.

The Company also made new progress in intellectual property protection. In February 2026, the patent term extension (PTE) application for dorzagliatin was formally approved by the China National Intellectual Property Administration, thereby the core patent protection period of dorzagliatin extended to April 2034 and an additional 5-year market exclusivity obtained, which provides a strong guarantee for the product’s long-term market competition.

In 2025, dorzagliatin was recognized as national innovation and an effective therapy for chronic diseases by the regulatory authorities in China. Accordingly, the same NRDL price was offered for the calendar years 2026 and 2027. Reimbursement coverage under the NRDL has significantly increased accessibility, especially in Tier 2 and Tier 3 hospitals, and played a critical role in accelerating patient adoption. The Company will continue to safeguard the product’s market competitiveness and patient accessibility and accelerate the popularization of the drug among patients.

- Advancement of Real-World Studies, Continuous Validation of Clinical Value

Real-world evidence (RWE) studies continue to corroborate the key role of dorzagliatin in improving glucose-dependent pancreatic islet secretion function, and demonstrate its efficacy in diabetes prevention, remission, and delaying or preventing diabetes complications.

The RWE study sponsored by Hua Medicine HMM0701 with 380 T2D patients was fully enrolled in 2025. The interim analysis, as reported at the 2025 American Diabetes Association (ADA), showed that 86% of such patients were taking two or more antidiabetic drugs and 41% of such patients were using insulin. After a 6-month treatment, a significant improvement of glycemic control was observed with HbA1c reduction from 8.1% to 7.3% with the mean time-in-range (TIR) levels increasing to over 70%. Thus far, the studies have demonstrated that when dorzagliatin is administered in combination with other antidiabetic drugs, such patients have experienced significantly improved post-meal glucose levels and improved β-cell function.

Separately, a mechanistic study with dorzagliatin (employing double-tracer measurement) was conducted in the United States to provide scientific evidence of hepatic glycogen formation in T2D patients with an average of 17 years of diagnosed diabetes. In this study, patients were treated with dorzagliatin twice daily for 6 weeks. The results showed that dorzagliatin increased direct glucose flux to hepatic glycogen implying the improvement of restoration of hepatic Glucokinase (GK) function. Together with the clinical research data that dorzagliatin improves early phase insulin release and GLP-1 secretion, recovery of hepatic glycogen synthesis in T2D patients offers an important path in controlling post-meal glucose excursion and provides a unique opportunity in controlling diabetes complications, such as diabetes kidney diseases and mild cognition impairment.

The RWE sponsored by Hua Medicine (HMM0601) has completed clinical trials with over 2,000 subjects, with average diabetes duration of 7.9 years and above 30% having disease duration more than 10 years. The initial results suggest that dorzagliatin is safe and well tolerated in Chinese T2DM patients. There were no new adverse effects observed in the study and the incident rate remains as low as what was observed in Phase III clinical trials. Patient adherence was generally high, with a mean adherence rate of approximately 95%. In this study, 80% of the participants have used one or more oral anti-diabetes medicine, and 20% used insulin. Dorzagliatin demonstrated good efficacy and safety not only in the overall population but also in elderly, obese, and hyperglycemic patient populations, whether used as monotherapy or in combination with metformin, SGLT2 inhibitors, insulin, and other medications. The topline results will be reported at the 2026 American Diabetes Association.

- Deepened Clinical R&D, Continuous Expansion of New Indications

New Indication for Dorzagliatin – MODY-2 Patients.

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 insulin secretion. 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 that currently available medications are not effective. In clinical studies with MODY-2 patients, China investigators have reported that dorzagliatin is effective in reducing blood glucose levels to normal levels in MODY-2 patients who previously failed to manage their elevated blood glucose levels when treated with metformin, TZD, DPP-IV inhibitors, and SGLT-2 inhibitors. Additional results demonstrated that 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 GLP-1 secretion. Based on such results, Hua Medicine has communicated and reached a consensus with the CDE at NMPA to file the IND submission of dorzagliatin for MODY-2 patients in 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 SENSITIZE 3 clinical study in Hong Kong in pre-diabetic (IGT) subjects and in early diabetes patients. 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 IVGTT and OGTT conditions to better define the clinical treatment baseline and endpoints. We expect to complete this study in 2026 and explore the opportunity to file IND applications of dorzagliatin for diabetes prevention in China and Asian Pacific regions thereafter. 

Dorzagliatin for Neurodegenerative Diseases.

MCI shows approximately 15.5% prevalence among elderly people in China and approximately 22% in the US, and is common in T2D patients with a 45% incidence rate. The 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 the 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. The bio-energy balance in the brain is largely dependent on the glucose homeostasis control in the peripheral organ and the neural network communication in the central and peripheral system via spatial temporal management. 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 mild cognitive impairment (MCI) and will initiate these first-in-disease clinical studies in the future.

Dorzagliatin for Frailty.

Frailty is an age-related geriatric syndrome characterized by reduced tolerance to internal and external stressors. Approximately 17% of Americans and 11% of Asians over the age of 50 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 supports the causal effects of glucokinase (GK) activation on lowering frailty risk. We plan to initiate clinical studies in the future to advance dorzagliatin’s application in frailty.

Development of combination therapy for diabetes and complications.

Dorzagliatin rescues pancreatic function in glucose insulin secretion and GLP-1 secretion, as evidenced by clinical and basic research results. It also improves hepatic insulin sensitivity and reduces hepatic insulin resistance through recovery of hepatic glycogen synthesis in T2D patients. The combination of dorzagliatin with DPP-IV inhibitors, SGLT-2 inhibitors, and GLP-1 agonists have demonstrated effective regulation of lipid metabolism. Studies in combination with anticancer PI3K inhibitors have also offered unique benefits for glucose homeostasis management.

- Diversified Product Pipeline, Innovative Layout for Future Growth

Hua Medicine continues to enrich its pipeline layout based on core products. The Company has accelerated the R&D of a fixed-dose combination (FDC) of dorzagliatin and metformin as a twice-daily therapy for Type 2 diabetes patients with inadequate glycemic control on metformin alone, to further improve patient medication compliance. The product is supported by the strong results of the loose-dose combination in both Phase III clinical trials and real-world use. The Company has submitted an IND application to NMPA, and the GMP commercial manufacturing process has been successfully carried out, preparing for the pivotal bioequivalence study for NDA filing in 2027. Clinical studies have shown that the combination of dorzagliatin and metformin can better control blood glucose, reduce postprandial blood glucose and improve fasting blood glucose, providing new clinical value for optimizing blood glucose homeostasis endpoints.

We have advanced our 2nd generation GKA as a once daily therapy for patients with obesity, leveraging dorzagliatin effects in improved glucose-stimulated GLP-1 secretion in the pancreas and in the intestine. The MAD study of the 2nd generation GKA was initiated in the United States with first-patient-in in December 2025, and we expect to report topline data by the middle of 2026.

Meanwhile, the Company is also exploring combination therapy regimens of dorzagliatin with GLP-1 receptor agonists, SGLT-2 inhibitors and other drugs. In a recently published clinical trial in China, researchers reported the superior benefits of our dorzagliatin in combination with semaglutide as compared to semaglutide alone in a 12-week study. The combination group showed superior results across several key measures, including glycemic control, bodyweight related indicators and β-cell function.

Financial Summary

- Revenue generated by the Company was approximately RMB 492.9 million from the sale of approximately 4.011 million packs of HuaTangNing, increases of approximately 93% and 91% respectively, as compared with the year ended December 31, 2024.

- Gross profit generated by the Company for the year ended December 31, 2025, was approximately RMB280.4 million, representing an increase of approximately 125%, as compared with the year ended December 31, 2024, and gross margins rose to 56.9%.

- Profit before tax increased by approximately 542% to approximately RMB1,106.4 million for the year ended December 31, 2025, as compared with the year ended December 31, 2024.

- Bank balances and cash position was approximately RMB1,092.3 million as of December 31, 2025.

- Expenditures incurred by the Company for the year ended December 31, 2025, were approximately RMB433.4 million.

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®,) 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.

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