March 29, 2025
- HuaTangNing completed its first full year for reimbursement under the National Reimbursement Drug List (NRDL), with continued expansion in hospital coverage. Compared with the 2023 year, sales volume increased by approximately 740%.- Sales revenue increased by 234% compared with the 2023 year, with cash reserves exceeding RMB 1 billion to fully support future R&D and commercialization activities.- A Phase I clinical study of our second-generation GKA, a once daily oral therapy, successfully completed in the United States. Our dorzagliatin-metformin fixed-dose combination formulation progressed smoothly and our product pipeline continued to advance and expand.- The Mendelian Randomization studies of human genetic data provided scientific evidence to support the exploration of glucokinase activation in diabetic complications and new clinical indications.- Manufacturing capacity of dorzagliatin continued to expand to meet growing market demand.- The establishment of Hua Medicine’s pharmaceutical sales and marketing team resulted in significant sales growth in the first two months of 2025, opening a new model of innovative drug commercialization.SHANGHAI, Mar 28, 2025 - (ACN Newswire via SeaPRwire.com) - Hua Medicine (“the Company”, Hong Kong Stock Exchange Stock Code: 2552) announced the audited full-year results of the Company and its subsidiaries for the year ended December 31, 2024 (the “Reporting Period”), along with the Company’s business progress in 2024 and future business outlook. Hua Medicine has made significant strides in the commercialization of its core product, the glucokinase activator (GKA) dorzagliatin (trade name: HuaTangNing, as well as in R&D innovation and manufacturing capacity optimization, laying a solid foundation for the Company’s long-term sustainable development.Dr. Li Chen, Founder and the Chief Executive Officer of Hua Medicine, stated: “In 2024, HuaTangNing’s market performance was very encouraging. Its inclusion in the NRDL greatly enhanced the accessibility and affordability of this innovative drug, enabling more diabetes patients to benefit. In 2025, Hua Medicine established a pharmaceutical sales and marketing team, and HuaTangNing demonstrated strong growth momentum at the start of the year. With further market expansion and increasing patient awareness, we are confident in HuaTangNing’s market growth.”“Looking ahead, the Company will continue to explore HuaTangNing’s potential in personalized diabetes treatment and diabetes complications globally. By integrating big data and artificial intelligence technologies, we aim to expand our disease areas into immune homeostasis and neural homeostasis. We are confident with the close collaboration of Hua Medicine and its partners across the pharmaceutical R&D, production, and distribution chain, we can enable more patients to access and benefit from Chinese medicines, accelerating progress in realizing our vision ‘China leading pharmaceutical innovation to advance human health.’”Summary of Clinical Research and Operational Progress- Significant Revenue Growth, Strong Market Performance of HuaTangNing, and Positive Patient Feedback- 2024 marked the first full year for which our HuaTangNing was reimbursed under the National Reimbursement Drug List (“NRDL”) in China. Sales revenue increased by 234% to RMB255.9 million for the fiscal year 2024 compared with the same period in 2023. During the fiscal year 2024, HuaTangNing was sold in approximately 2,700 hospitals across China. As of December 31, 2024, Hua Medicine maintained a strong balance sheet with a cash balance of RMB1,139.8 million to support its full-scale commercialization, business development and R&D functions.- Since the launch of HuaTangNing in the fourth quarter of 2022, our pharmacovigilance team has been diligently monitoring the safety of dorzagliatin in the China market, and was recently recognized by the National Adverse Drug Reaction Monitoring Center as a national example for the pharmaceutical industry. As of December 31, 2024, Hua Medicine had monitored approximately 150,000 patients who have been prescribed HuaTangNing, and dorzagliatin has been observed to be safe and well tolerated by patients.- Effective January 1, 2025, Hua Medicine assumed full responsibility for the commercialization of HuaTangNing in China from its former sales and marketing partner, Bayer Healthcare Company Limited (“Bayer”). We recruited Mr. Lu Yu, a seasoned pharmaceutical sales executive with over 20 years of diabetes commercialization experience in China, to lead our sales and marketing efforts.- For the two months ended February 28, 2025, Hua Medicine sold approximately 592,000 packs of HuaTangNing, representing approximately RMB73.2 million in net sales. During the same period in 2024, approximately 202,000 packs of HuaTangNing were sold, representing approximately RMB24.5 million in net sales, The difference represents a significant increase in sales over a period during which the price per pack remained the same. This demonstrates a smooth transition of HuaTangNing’s commercialization in China from Bayer to Hua Medicine, with reinvigorated growth momentum.- Upon the termination of the Exclusive Promotion Service Agreement, the unamortized contact liabilities amounting to RMB1,243,499,000 were released to profit or loss, and will be recognized as a gain in 2025 by the Group. Both parties have confirmed in a signed letter that there are no outstanding matters arising from such termination, nor does either party owe the other party any obligation or liabilities from such separation.- Steady Progress in R&D Innovation, Continuously Enriching Product Pipeline- Hua Medicine made significant headway in preparing the future expansion of our glucokinase-targeted, glucose homeostasis-centered therapy into the international markets, specifically the United States. We successfully completed and announced the results of its single-ascending dose (“SAD”) study in the United States of our second generation GKA (HM-002-1005), in which we validated the feasibility of dorzagliatin as a once daily oral therapy for Type 2 diabetes (“T2D”) patients. We are currently developing the clinical dosage form for advancement of HM-002-1005 in a clinical proof-of-mechanism study.- Hua Medicine also made significant progress in developing fixed-dose combination formulations. The Company has been advancing its dorzagliatin-metformin fixed-dose combination product candidate into commercial dosage development, with process validation expected to be completed in 2025.- Based on human genetic data collected from studies of patients administered with dorzagliatin, the Mendelian Randomization methodology has been applied to predict the beneficial effects of dorzagliatin on related and significant diabetes complications, such as reduction in heart failure, coronary artery disease, memory loss and dyslipidemia. In addition, a separate Mendelian Randomization study provided genetic evidence supporting the causal effects of glucokinase activation on lowering the risk of frailty. These findings suggest that glucokinase activators may aid in the management of frailty and sarcopaenia in people with diabetes. We will continue our research and development efforts to explore new indications.- Through our SENSITIZE 3 clinical study in Hong Kong, Hua Medicine is advancing the potential of dorzagliatin in prediabetes, early treatment and prevention of Type 2 diabetes. In contrast with the approved 75mg dosage form of HuaTangNing, the Company is testing new 25mg and 50mg dosage formulations to explore these potential new indications. The Company is also supporting an investigator-sponsored trial in testing dorzagliatin’s efficacy in treating MODY-2 patients who suffered from genetic mutations that de-activated glucokinase. Early studies in humans by renowned diabetes experts Dr. Juliana Chan and Dr. Linong Ji have indicated the benefit of dorzagliatin in MODY-2 patients by improving their β-cell functions and glycemic control.- Hua Medicine is also advancing the combination of dorzagliatin with GLP-1RA, DPP-IV inhibitors and SGLT-2 inhibitor 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 indication into other diseases in metabolic disorders, such as obesity and MASH. - Hua Medicine will continue our engagement in diabetes prevention, opportunities in longevity and prevention of memory loss and eventually find a new way to increase healthy life span and longevity in humans.- Continued Expansion of Manufacturing Capacity, Plans to Launch Dorzagliatin in New Markets- Hua Medicine continues to invest in expanding its manufacturing capacity to meet anticipated market needs in 2026 and 2027.- Hua Medicine is also finalizing and preparing to submit registration applications for dorzagliatin to launch commercialization in the Macau and Hong Kong markets. We plan to submit both applications in 2025.- Hua Medicine continues to strengthen its intellectual property protection globally. As of December 31, 2024, the Company owned more than 200 granted patents covering its proprietary technology worldwide.Business outlook- There is a great opportunity for dorzagliatin and our 2nd generation GKA in China and the global oral anti-diabetes market. - We will strengthen our own commercialization efforts through hub and spoke development with focus on building up a strong internal sales and medical marketing organization to drive business growth in 2025. This will allow us to rebuild our strong connections directly to the medical community and better promote HuaTangNing in China and surrounding areas.- We continue to invest into digital technology platforms to create synergies across functions and enhance branding opportunities using AI technology.- We are working on the registration of dorzagliatin in HK and Macau region and engage partnerships in Southeastern Asia and Belt and Road nations. In addition, business development work on our 2nd generation GKA in regions with high incidences of obesity will be continued based on the initial success of the SAD study in the United States.Financial SummaryFor the year ended December 31, 2024:- Bank balances and cash position was approximately RMB1,139.8 million.- Total revenue was approximately RMB255.9 million, an increase of approximately 234% compared to the full year of 2023; approximately 2,105,000 packs of HuaTangNing were sold, an increase of approximately 740% compared to the full year of 2023.- Total other income was approximately RMB116.8 million, including approximately RMB95.7 million from the amortization of Bayer milestone income.- Total expenditures for the year was approximately RMB493.6 million, of which R&D expenses accounted for approximately RMB215.1 million.- Loss before tax was approximately RMB250.1 million, which was mainly attributable to the increase of selling expense and research and development expense.Forward-Looking StatementsThis 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 MedicineHua 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.For more information Hua MedicineWebsite:www.huamedicine.comInvestorsEmail:ir@huamedicine.comMediaEmail: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 ACN Newswire via SeaPRwire.com.
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