Hua Medicine Announces 2025 Interim Results

SHANGHAI, Aug 28, 2025 - (ACN Newswire) - Hua Medicine (the &ldquo;Company&rdquo;, HKEx: 2552) announced the unaudited consolidated results of the Company and its subsidiaries for the six months ended June 30, 2025 (the &ldquo;Reporting Period&rdquo;), as well as the Company's business progress during the first half of the year and future outlook. During the Reporting Period, the commercialization of the Company's core product, HuaTangNing (dorzagliatin tablets), accelerated. The Company&rsquo;s independent operational capabilities improved significantly. R&D progress advanced smoothly and the Company&rsquo;s financial performance achieved breakthrough growth, laying a solid foundation for long-term sustainable development.Sales of HuaTangNing increased by 108% year-on-year, with net sales increasing by 112% year-on-year. Reimbursement coverage continued to expand, with a significant increase in prescription volumes across Tier 2 and Tier 3 hospitals, as our comprehensive commercialization strategy achieved significant results.Following the termination of the exclusive promotion service agreement with Bayer, the Company recognized a one-time release of previously deferred income of RMB 1,243.5 million, achieving a profit of RMB 1,183.9 million for the first half of the year. This is the Company's first profit during the performance period.A real-world study (BLOOM) involving 80 centers and 2,000 patients with Type 2 diabetes conducted in China further demonstrated the broad applicability and safety of dorzagliatin.A registration application has been submitted in Hong Kong for Dorzagliatin 75mg (brand name: MYHOMSIS&reg;), aiming to extend its presence across Greater China and Southeast Asia.Gross profit margin improved significantly, as production scale and operational efficiency continued to be optimized.&ldquo;The first half of 2025 was a critical stage in Hua Medicine&rsquo;s transformation and development. Following the full takeover of the commercialization of HuaTangNing, the Company achieved double-digit growth in sales and revenue through its independently established sales team, thereby validating the effectiveness of the new business model. We have also submitted a new drug application in Hong Kong, China, laying the foundation for dorzagliatin to expand from China to Southeast Asia and the global market,&rdquo; said Dr. Li Chen, founder and CEO of Hua Medicin&ldquo;Dorzagliatin has continued to demonstrate broad therapeutic potential in real-world studies, and new evidence has been found in basic research regarding diabetes remission, cognitive improvement, lipid improvement, and muscle gain, further consolidating Hua Medicine&rsquo;s global leadership in GKA research and development and treatment. In the future, Hua Medicine will continue to focus on diabetes and the entire field of metabolic diseases, driving innovation through research and development and market expansion to bring the benefits of China's original innovative drugs to more patients worldwide.&rdquo;Business Highlights and Operational ProgressCommercialization transformation achieved remarkable results, with doubling of sales and profits.Effective from January 1, 2025, the Company terminated its exclusive promotion service agreement with Bayer and fully took over the commercialization of HuaTangNing (&aring;''&aring; &sbquo;&aring;&reg;'&reg;) in China. During the Reporting Period, with unit prices remaining consistent with the same period in 2024, sales of HuaTangNing reached 1,764,000 packs, a year-on-year increase of 108%. Net sales reached RMB217.4 million, a year-on-year increase of 112%. Leveraging strong commercial execution and continuously improving operational efficiency, the Company is moving toward profitability. Hua Medicine has successfully transitioned to a fully independent commercialization phase, confirming growing market demand and the efficient execution capabilities of its independent sales team.Sales of HuaTangNing continued to benefit from its inclusion in China&rsquo;s National Reimbursement Drug List (NRDL), which took effect in January 2024. 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.Due to expanded production scale and improved cost efficiency, the Company's gross profit margin increased to 54.2%, higher than 46.5% in the same period last year.With sales revenue growing 112% year-on-year, the Company's sales expenses during the Reporting Period were RMB64.2 million for the six months ended June 30, 2025, growing only 5% compared to the same period last year. The composition of our selling expenses for the six months ended June 30, 2025 changed significantly from the same period in 2024 due to the Company incurring selling expenses directly as a result of assuming sole commercialization responsibilities for HuaTangNing in China, while no longer owing promotion expenses to the former commercialization partner. These figures also reflect a significant positive trend towards profitability and demonstrate our business strategy of optimizing profitability by controlling commercialization sales expenses of HuaTangNing and maximizing production efficiency, where our selling expenses in the first half of 2025 represent approximately 29.5% of total revenue whereas in the first half of 2024, our selling expenses represented approximately 59.5% of total revenue.After terminating the exclusive promotion service agreement with Bayer, the Company recognized a one-time release of previously deferred income of RMB1,243.5 million and transitioned to self-driven growth. Hua Medicine achieved a pre-tax profit of RMB 1,183.9 million for the first half of the year, marking a key milestone of Hua Medicine towards sustainable profitability.As of June 30, 2025, the cash balance was RMB1,022.8 million, laying a solid foundation for the Company's future R&D and commercialization initiatives.Clinical research continues to deepen, with new evidence supporting treatment potentialHua Medicine is conducting multiple post-marketing studies to evaluate the long-term safety and effectiveness of dorzagliatin across diverse patient populations, both in monotherapy as well as in combination with other popular approved anti-diabetic drugs, such as GLP-1 receptor agonists, insulin, DPP-IV inhibitors and SGLT-2 inhibitors. These studies are generating new clinical insights into glucose control, cognitive outcomes, and potential for diabetes remission.A real-world study (BLOOM) is being conducted in 2,000 patients with Type 2 diabetes across 80 centers in China. BLOOM has already completed one-year follow-up in over 1,000 participants. In the real-world setting, BLOOM further demonstrates the broad applicability and safety of dorzagliatin. Patients receiving dorzagliatin in routine clinical practice present with a heterogeneous mix of comorbidities, including various cardiovascular and renal disorders and are managed with multiple concomitant medications. In addition to metformin, more than 60% of patients concurrently used SGLT-2 inhibitors, insulin, GLP-1 receptor agonists, or DPP-IV inhibitors and other anti-diabetic drugs with dorzagliatin. In monotherapy or in combination with the popular above-mentioned anti-diabetic drugs, dorzagliatin was generally well tolerated, and its safety profile remained consistent with previously established data.Hua Medicine presented new data at the 2025 American Diabetes Association (ADA) conference, reinforcing dorzagliatin&rsquo;s potential as a disease-modifying therapy. Insights into the novel mechanism of action (MOA) of dorzagliatin as a therapeutic GKA were published in Diabetes.Research and Development Pipeline and Future OutlookThe company filed its application for registration of dorzagliatin 75mg in Hong Kong as MYHOMSIS&reg;, aiming to extend its presence across Greater China and southeast Asia.We are continuing expansion on our product pipeline through development of fixed dose combination of metformin and dorzagliatin for patients who have failed to control blood glucose levels while using high dose metformin (daily dose>1500 mg). In the loose dose combination study-DAWN Trial, dorzagliatin add-on to metformin provided HbA1c reduction of greater than 1% and post meal glucose reduction of greater than 5 mmol/L. These desirable glycemic control levels coupled with a very safe 0.8% hypoglycemic rate would suggest strong potential demand for a branded oral anti-diabetic medication using a convenient fixed dose combination of dorzagliatin and metformin. The Pre-IND submission has been achieved in August 2025, and we are expected to initiate the bioequivalence study in early 2026.We are also advancing the combination of dorzagliatin with GLP-1RA, SGLT-2 inhibitors, insulin and DPP-IV inhibitors through combined effects in collecting real world evidence and proof of concept studies in animal models. The synergy between dorzagliatin with these agents has the potential to expand our indications into other diseases in metabolic disorders, such as obesity and MASH.We continue to enhance our collaborations with leading international research institutions. A Phase I investigator-initiated trial supported by the Group and conducted at the University of Pennsylvania &ndash; designed to evaluate the efficacy and safety of dorzagliatin in patients with cystic fibrosis-related diabetes (CFRD) &ndash; has received clearance from the U.S. FDA.We will continue our engagement in diabetes prevention, opportunities in metabolic disorder related neurodegeneration disease and eventually find a new way to increase healthy life span and longevity in humans.We continue to invest in digital technology platforms to create synergies across functions and enhance branding opportunities using AI technology.As illustrated in our product pipeline chart, we will continue to advance our R&D efforts for both dorzagliatin and our 2nd generation GKA on our own as well as in collaboration with academic and strategic partners. We are working on the registration of dorzagliatin in Hong Kong and continue to seek partnerships in Southeast Asia and Belt and Road nations. In addition, we will continue our business development efforts on our 2nd generation GKA for the global markets based on the initial success of the Phase 1 single-ascending dose study in the United States and the initiation of our Phase 1 multiple ascending dose study planned for late 2025 or early 2026.Financial SummaryAs of June 30, 2025- Bank balances and cash amounted to approximately RMB 1,022.8 million.- Total revenue was approximately RMB217.4 million, representing a year-on-year increase of 112%. Sales of HuaTangNing (&aring;''&aring;&sbquo;&aring;&reg;'&reg;) reached 1,764,000 packs, representing a year-on-year increase of 108%.- Total gross profit was approximately RMB117.8 million, representing a year-on-year increase of 147%. Gross margin was approximately 54.2%, increased by approximately 7.7 percentage points, as compared with the six months ended June 30, 2024.- Total other income amounted to approximately RMB1,254.6 million , of which Bayer's one-time release of previously deferred income was RMB1,243,5 million.- Total expenditures were approximately RMB187.1 million, of which research and development expenditure was approximately RMB65.8 million.- Profit before tax was approximately RMB1,183.9 million, representing approximately 932% for the six months ended June 30, 2025Forward-Looking StatementsThis document contains statements regarding Hua Medicine&rsquo;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 MedicineHua Medicine (The &ldquo;Company&rdquo;) 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.For more informationHua MedicineWebsite:www.huamedicine.comInvestorsE-mail:ir@huamedicine.comMediaE-mail:pr@huamedicine.comPress DisclaimerFor accuracy and completeness in context, information related to products marketed in China in this material, especially those identified or required, should comply with documents approved by Chinese regulatory authorities.Additionally, such information should not be interpreted as a recommendation or promotion of any drug or treatment, nor should it replace medical advice from healthcare professionals. For medical-related matters, please consult a healthcare professional. Copyright 2025 JCN Newswire. All rights reserved. www.jcnnewswire.com

Hua Medicine Announces 2025 Interim Results

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