Press Release: Hua Medicine Announces 2025 Interim Results

Dow Jones
Aug 28
   -- Sales of HuaTangNing ( (R)) 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$(R)$, TM), 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. 

SHANGHAI, Aug. 28, 2025 /PRNewswire/ -- Hua Medicine (the "Company", HKEx: 2552) announced the unaudited consolidated results of the Company and its subsidiaries for the six months ended June 30, 2025 (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, the commercialization of the Company's core product, HuaTangNing ( (R)) (dorzagliatin tablets), accelerated. The Company's independent operational capabilities improved significantly. R&D progress advanced smoothly and the Company's financial performance achieved breakthrough growth, laying a solid foundation for long-term sustainable development.

"The first half of 2025 was a critical stage in Hua Medicine's transformation and development. Following the full takeover of the commercialization of HuaTangNing ( (R)), 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," said Dr. Li Chen, founder and CEO of Hua Medicine, "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'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."

Business Highlights and Operational Progress

   -- Commercialization 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 ( (R)) in China. During 
             the Reporting Period, with unit prices remaining consistent with 
             the same period in 2024, sales of HuaTangNing ( (R)) 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 ( (R)) continued to benefit from its 
             inclusion in China'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 ( (R)) 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 ( (R)) 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 potential 
 
          -- Hua 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'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 Outlook

   -- The company filed its application for registration of dorzagliatin 75mg 
      in Hong Kong as MYHOMSIS(R) ( TM), 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 -- designed 
      to evaluate the efficacy and safety of dorzagliatin in patients with 
      cystic fibrosis-related diabetes (CFRD) -- 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 Summary

As 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 ( (R)) 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, 2025 

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. 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 (( (R)),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 information

Hua Medicine

Website: www.huamedicine.com

Press Disclaimer

For 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.

View original content:https://www.prnewswire.com/news-releases/hua-medicine-announces-2025-interim-results-302540936.html

SOURCE Hua Medicine

 

(END) Dow Jones Newswires

August 28, 2025 05:54 ET (09:54 GMT)

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