Tag: Hua Medicine

– 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.

Hua Medicine (the Company, HKG: 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 Summary

For 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 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(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
Investors
Email:ir@huamedicine.com
Media
Email:pr@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.

On February 27th, the awarding ceremony of the second batch of Shanghai Innovative Enterprise Headquarters was held in Shanghai. Gong Zheng, Deputy Secretary of Shanghai Municipal Party Committee and Mayor of Shanghai, awarded the certificates to 49 innovative enterprise headquarters, and Hua Medicine was among them. Dr. Li Chen, the founder and CEO of the Company, went on stage to receive the award and delivered a speech as a representative of the enterprises.

Innovative enterprises are an important part of Shanghai’s modern industrial system and the source of vitality for Shanghai’s high-quality development. In recent years, innovative enterprises in Shanghai have been growing and developing rapidly, having an obvious driving effect on the industry. The enterprises awarded this time are from key industrial fields such as integrated circuits, biomedicine, artificial intelligence, digital economy, and emerging strategic comprehensive industries. All the selected enterprises exhibit the characteristics of strong innovation leadership, vigorous development vitality, and obvious agglomeration development.

Hua Medicine, headquartered in Shanghai but with a global outlook, is leveraging China’s evolving pharmaceutical regulatory landscape and the innovative drug full-chain industrial environment such as the pharmaceutical research and development, production, and business environment created by Shanghai to continuously accelerate the transformation and implementation of innovative achievements. Hua Medicine took ten years to develop a globally first-in-class and national Class I new drug, glucokinase activator (GKA) dorzagliatin (Trade name:) independently, which was first launched in China, with a globally new target and a new mechanism.

In September 2022, dorzagliatin was approved for marketing by the National Medical Products Administration of China for the treatment of type 2 diabetes. It is the first GKA approved for marketing worldwide and has also become the tenth class of diabetes treatment drugs recognized by the World Health Organization (WHO). By the end of 2023, dorzagliatin was successfully included in China’s National Reimbursement Drug List (NRDL), greatly improving the accessibility and affordability of this innovative drug for patients.

As a global innovation leader in the GKA field, Hua Medicine has received national-level awards on multiple occasions during the research and development period and after the product launch, and has undertaken major national projects. These include being consecutively selected as a major new drug development special project under the “12th Five-Year Plan” and the “13th Five-Year Plan” by the Ministry of Science and Technology, and winning the First Prize of the Science and Technology Award of the Chinese Pharmaceutical Association, among others.

Currently, Hua Medicine is actively carrying out the development of the second-generation GKA and fixed combination preparations, aiming to bring more innovative and good drugs to patients in China and even globally in the fields of diabetes and its complications, such as obesity and diabetic nephropathy.

As a representative of the enterprises, Dr. Li Chen said in his speech at the awarding ceremony: “Coinciding with the new era and new journey of Shanghai accelerating the construction of a scientific and technological innovation center and fully promoting the upgrading and development of strategic emerging industries, Hua Medicine being recognized as the Shanghai Innovative Enterprise Headquarters is an affirmation of the enterprise’s past and also an encouragement and inspiration for the enterprise’s future development. Hua Medicine will continue to leverage its advantages of conceptual innovation, technological innovation, and model innovation, keep making progress, and contribute to the construction of Shanghai’s scientific and technological innovation center and the innovative development of the biomedicine industry.”

Receiving the title of “Shanghai Innovative Enterprise Headquarters” this time is not only an honor for Hua Medicine but also a responsibility and mission. In the future, taking this as an opportunity, Hua Medicine will continuously increase its innovation investment and the ability of achievement transformation, continuously enhance its international competitiveness, provide more high-quality innovative drugs and treatment solutions for patients, help Shanghai’s biomedicine industry reach new heights, and promote the construction of the “Healthy China” strategy.

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.

For more information
Hua Medicine
Website: www.huamedicine.com
Investors
E-mail: ir@huamedicine.com
Media
Email: pr@huamedicine.com

Hua Medicine (the Company, HKG: 2552) announced today that the Company has successfully completed a Phase I clinical trial on its 2nd generation GKA candidate in U.S. at the 9th China BioMed Innovation and Investment Conference (CBIIC).

The Phase Ia clinical trial of the second-generation GKA (HM-002-1005) was conducted in the United States in 40 subjects with Type 2 diabetes (T2D). This trial was randomized, double-blind, placebo-controlled, single-dose, focusing on safety, tolerability, and pharmacokinetics. The second-generation GKA is a novel molecular entity with optimized physicochemical properties, holding new patents, and serving as the prodrug of dorzagliatin (HMS5552). This study designed for once-daily oral administration. Its aim is to extend the drug’s action duration in the body through sustained-release technology, enhance patient compliance, and prolong the stimulation of GLP-1 secretion in the intestines.

The Single Ascending Dose (SAD) study demonstrates that HM-002-1005 tablets can be rapidly converted to HMS5552 in the human body, with minimal exposure level of prodrug in both blood and urine. The t1/2 (biological half-life) after a single dose of HM-002-1005 tablets was prolonged compared to dorzagliatin tablets. The Cmax of HMS5552 in plasma after a 184.5mg single dose is comparable to the plasma concentration of HMS5552 after a 75mg single dose of dorzagliatin tablet; likewise, the daily AUC of HMS5552 in plasma after a single dose of HM-002-1005 tablets is comparable to the exposure level of HMS5552 after a 75mg BID dose of dorzagliatin tablets. The research indicates that HM-002-1005 tablets are near-completely converted to HMS5552 in human, and its pharmacokinetic characteristics support for once-daily oral administration. The development of HM-002-1005 tablets not only contributes to enhancing patient medication adherence and effectively control blood glucose levels within 24 hours; meanwhile, it also offers the opportunity to explore the Maximum Tolerated Dose above 150mg daily to achieve better efficacy. The 75 mg BID dose regiment was developed under the concept of Minimum Therapeutic Effective Dose in Chinese T2D patients who suffered from an impairment of insulin secretion and significant reduction of early phase insulin. The different disease characters of T2D with obesity in western patient population would benefit dorzagliatin from its effects on GLP-1 secretion and improvement of insulin sensitivity.

With the confirmation that the exposure level of HM-002-1005 tablets at 184.5mg is comparable to dorzagliatin tablets at 75mg (BID), we will further optimize the dosage form followed by a Multiple Ascending Dose (MAD) clinical development of the 2nd generation GKA in China and the United States.

Dr. Li CHEN, founder and CEO of Hua Medicine, stated, “Hua Medicine has always been committed to treating Type 2 diabetes at its root cause by restoring patients’ ability to autonomously regulate blood glucose levels. Over the course of a decade, the Company has selected dosing and clinical research protocols that are safe and effective for the majority of Chinese diabetes patients, leading to the successful development of GKA and the clinical application of dorzagliatin. Building on this foundation, the Company will undergo a strategic upgrade by further exploring the therapeutic potential of GKA, enriching its product pipeline and seeking partners both domestically and internationally, in order to benefit a broader range of patients, expand into global markets, and effectively establish the brand identity of GKA medications while maximizing the commercial potential of our global first-in-class drugs.”

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.

For more information
Hua Medicine
Website: www.huamedicine.com
Investors
E-mail: ir@huamedicine.com
Media
E-mail: pr@huamedicine.com

Hua Medicine (the Company, HKG: 2552) announced today that the Company has successfully completed its SENSITIZE study on the mechanism by which dorzagliatin improves the β-cell glucose sensitivity at the 9th China BioMed Innovation and Investment Conference (CBIIC).

The SENSITIZE study was initiated by Professor Juliana Chan, an international endocrinology specialist at The Chinese University of Hong Kong, as the lead researcher. It is the first clinical study in Asian populations to evaluate the impact of GKA on β-cell glucose sensitivity in the populations with varying degrees of impaired glucose tolerance using the technology of hyperglycemic clamp. The study aims to explore the impairment of glucokinase (GK) function and clinical characteristics in different types of glucose dysregulation, providing new scientific evidence on the pathophysiology of Asian Type 2 diabetes and the central role of GK in blood glucose regulation.

The SENSITIZE 2 study results announced at CBIIC demonstrate that a single dose of dorzagliatin restores GK enzyme activity, significantly improving the second-phase insulin secretion and β-cell glucose sensitivity in individuals with impaired glucose tolerance (IGT) in hyperglycemic clamp study. In addition, the SENSITIZE 1 study previously reported at the 2022 ADA annual meeting showed that dorzagliatin directly restores the activity of GK mutants, leading to significant improvements in the second-phase insulin secretion and β-cell glucose sensitivity in patients with glucokinase monogenic diabetes (GCK-MODY or MODY-2), and significantly enhance basal insulin secretion in newly diagnosed type 2 diabetes patients.

Hua Medicine will continue to investigate β-cell glucose sensitivity improvement and incretin effect in response of repeated dose of dorzagliatin in individuals with intermediate hyperglycemia (IH) and Type 2 diabetes, in order to establish personalized intervention and treatment management plans for prediabetic and Type 2 diabetes patients.

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.

For more information
Hua Medicine
Website: www.huamedicine.com

Investors
E-mail: ir@huamedicine.com
Media
E-mail: pr@huamedicine.com

The 17th “C.C. Tan Life Science Award” ceremony was held at Shenyang Pharmaceutical University on October 9th. Dr. Chen Li, Founder and Chief Executive Officer of Hua Medicine, was awarded the “C.C. Tan Life Science Industrialization Award”. C.C. Tan Life Science Award has the highest honor as “the Chinese Nobel” in life science. In the context of the comprehensive construction of Chinese-style modernization and the development of new productivity, this award is a high recognition of Dr. Chen Li’s outstanding contributions to the industrialization of life science achievements, and a full affirmation of his decades-long efforts to promote conceptual, technological and institutional innovations in biopharmaceutical industry.

“C.C. Tan Life Science Award” was proposed by Mr. Tan Jiazhen, one of the founders of modern genetics in China and an outstanding scientist and educator in modern China, which was approved by the Ministry of Science and Technology of the People’s Republic of China, aims to promote the industrialization of China’s life sciences research results and stimulate life scientists to make innovations. Since its establishment in 2008, C.C. Tan Life Science Award has been awarded annually to scientists, professors and young scholars who have made achievements in life science in the People’s Republic of China and have made outstanding contributions to the industrialization of scientific and technological achievements in life science.

With more than 30 years of experience in new drug R&D and management, Dr. Chen Li returned to Shanghai from the U.S. in 2004, and participated in the establishment of Roche R&D Center, the first R&D center of a multinational company in Shanghai, bringing the advanced experience, talent concept, technical standards and quality management system of international new drug R&D to China, and contributing to the establishment of the environment of China’s biopharmaceutical industry. Dr. Chen Li has contributed to the establishment of China’s biopharmaceutical industry environment.

In 2010, Dr. Chen Li founded Hua Medicine in Zhangjiang, Shanghai, with the original intention of “China leads the way in pharmaceutical innovation”, adhering to the tenet of “patients first, innovation first, and good medicines for the people”, focusing on the unmet clinical needs, and concentrating on the research and development of first-of-its-kind new medicines for diabetes. Dr. Chen Li is not only one of the earliest pioneers to leave his executive position at a multinational pharmaceutical company to start a local innovative drug company, but also a leader in developing First-in-Class drugs in China.

In September 2022, under the leadership of Dr. Chen Li, Hua Medicine’s world’s first, China’s first, Class I National New Drug, Dorzagliatin (trade name: HuaTangNing®), which took ten years to develop independently, received marketing approval from the State Food and Drug Administration (SFDA), making it the first Glucose Kinesin Activator (GKA) approved and marketed globally, and the tenth class of diabetes therapeutic drugs.

As the world’s first GKA drug, Dorzagliatin utilizes the new concept of “repairing sensing, reshaping homeostasis, and treating diabetes at the source” to achieve the improvement of blood glucose homeostasis dysregulation in patients with type 2 diabetes mellitus, and to bring a brand-new treatment for diabetes mellitus patients, which is a major breakthrough in the history of drug research and development of China in the field of major chronic diseases.  

During the development of Hua Medicine, Dr. Chen Li has actively contributed to the development of China’s biopharmaceutical industry. He has provided constructive opinions and suggestions for the system of marketing license holders and the system of patent linkage and patent protection, etc. He has cooperated with enterprises in the industry chain in the R&D and production of dorzagliatin to establish a joint innovation model, which has led to the development of the ecological development of the biopharmaceutical industry. In early 2024, Dr. Chen Li was awarded the first “Shanghai Outstanding Talent”. He is also the inventor of 119 granted invention patents and 270 invention patent applications and has been published more than 70 scientific papers in Nature Medicine, Lancet Diabetes Endocrinology, Nature Communication, PNAS, Diabetes, Obesity Metabolism, and the Journal of Biomedicine. PNAS, Diabetes, Obesity Metabolism, JACS, JOC and other international academic journals.

About Hua Medicine
Hua Medicine 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 on hydrochloride-tolerated 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 varying degrees of renal function impairment (including end-stage renal impairment without dialysis). Hua Medicine partnered with Bayer, a leading global pharmaceutical company, to commercialize HuaTangNing in China, benefiting diabetic patients and their families.

For more information
Hua Medicine
Website:  www.huamedicine.com
Investors
E-mail: ir@huamedicine.com
Media
E-mail: pr@huamedicine.com

First-in-class glucokinase activator (GKA) HuaTangNing (dorzagliatin) was approved in China in September 2022. Since the launch of commercial sales at the end of October 2022 to June 30, 2023, HuaTangNing achieved a total sales revenue of RMB87.9 million. For the first half of 2023, approximately 212,000 boxes of HuaTangNing were sold, and Hua Medicine achieved revenues of RMB70.3 million, representing approximately a 299.6% increase in revenue compared with the second half of 2022.

• The Company filed an application to include dorzagliatin in China’s National Reimbursement Drug List (NRDL) and is preparing the pharmacoeconomic value discussion with regulatory agencies in the near future. According to the National Healthcare Security Administration, dorzagliatin has passed the preliminary formal examination.
• The Company invested in dorzagliatin scale-up manufacturing capabilities at Changzhou SynTheAll (STA), Zhejiang Raybow and Shanghai Desano upon its successful commercial launch and during the initial out-of-pocket stage of commercialization.
• The Company has advanced the development of 2nd generation of GKA in overseas markets. Our team is preparing an Investigational New Drug (IND) filing in the United States either by year-end 2023 or early 2024.
• The Company has discovered additional therapeutic advantages of dorzagliatin in medical care, including the restoration of endogenous GLP-1 secretion, prevention of cognitive dysfunction, better glycemic control in obese patients with diabetes, and diabetes prevention enabled by reversing impaired glucose tolerance (IGT) to normal glucose tolerance (NGT).
• As of June 30, 2023, our cash balance was RMB881.3 million, representing an increase of approximately 79.6% as of December 31, 2022. The Company received RMB400 million non-refundable milestone payment from Bayer. With additional government funding, our total cash received from Bayer and government funding in the first half of 2023 was RMB402.6 million.
• On August 17, 2023, the Group and Bayer confirmed the achievement of a certain milestone relating to the development of HuaTangNing. Pursuant to the terms of the commercialization agreement between the Group and Bayer, the Group is entitled to receive a milestone payment of RMB800 million from Bayer.

Hua Medicine (the “Company”, HKEx: 2552) today announces the unaudited consolidated results of the Company and its subsidiaries for the six months ended June 30, 2023 (the “Reporting Period”).

Dr. Li Chen, the founder and CEO of Hua Medicine, said, “The first half of 2023 was a critical stage for Hua Medicine to begin commercialization. Since successful approval and the launch of prescription sales of dorzagliatin, the Company has worked closely with Bayer across the major channels of online drug stores, retail pharmacies and hospital pharmacies. The result has been a substantial growth of sales that is boosting our confidence in faster growth of dorzagliatin in the future.”

“As market demand and user numbers increase, we will carry out more real-world studies on dorzagliatin to meet more unmet clinical needs. In addition, Hua Medicine continues to make breakthroughs in exploring new treatment opportunities for dorzagliatin, including a wider range of indications and product pipelines for more countries and regions. Hua Medicine will continue to work with our partners in exploring more paths for the development of first-in-class drugs in China and around the world, and helping people live healthy and fulfilling lives,” Dr. Chen said.

Progress of Clinical Research and Company Operations

• In March 2023, the Company published a research paper in Nature Communications. The paper discusses studies which show that through its modulation of the glucose sensor glucokinase (GK) function and by repairing impaired GLP-1 secretion in patients with diabetes and obesity, dorzagliatin is expected to secure a new indication related to endogenous GLP-1. The study further demonstrated that dorzagliatin restored impaired glucose homeostasis in T2D patients through its action on GK targets located in the pancreas, intestine, and liver. This may offer a more effective way to achieve diabetes remission in obese diabetes patients through a combination of dorzagliatin with a GLP-1 receptor agonist.
• In June 2023, the Company presented the positive effects of dorzagliatin in the prevention of diabetes and memory deterioration in GK rats at the June 2023 American Diabetes Association (ADA) Scientific Sessions. The Company has filed patents in this area and will continue to expand its research into the benefit of dorzagliatin in disease prevention.
• In June 2023, the Company published our results of a prospective SEED-DREAM study in Chinese non-obese diabetes patients in the well-recognized journal, Diabetes, Obesity and Metabolism, in which we have reported a 65% remission probability during 52 weeks in subjects who have improved their TIR (Time-In-Range, a parameter that represents a better homeostasis control) after dorzagliatin treatment. We have further revealed the determinant factors for achieving diabetes remission after dorzagliatin treatment during the SEED study. These factors include a significant improvement of beta cell function and disposition index, reduction of post prandial glucose and significant increase of TIR during the SEED trial. Improvement of TIR is strongly correlated with reducing the risks of various diabetes complications, including heart attack, stroke and renal disease, as well as neurodegenerative disorders.
• The Company has filed its National Reimbursement Drug List (NRDL) application for dorzagliatin in China and is preparing the pharmacoeconomic value discussion with regulatory agencies in the near future. According to the National Healthcare Security Administration, dorzagliatin has passed the preliminary formal examination.
• Hua Medicine has worked with its manufacturing partners since the drug approval to manage market needs. We have secured adequate dorzagliatin supply for the 2023 calendar year, and initiated investment into dorzagliatin manufacturing capability at Changzhou SynTheAll (STA), Zhejiang Raybow and Shanghai Desano after the successful commercialization launch during the initial out-of-pocket stage. The total investment in 2023-2024 for commercial drug manufacturing and capacity expansion is expected to be in the range of RMB400 million.
• The Company is investigating the potential of dorzagliatin in diabetes prevention in a clinical study. After the initiation of the SENSITIZE II study at Chinese University of Hong Kong (CUHK), the Company is developing clinical study plans of reversing impaired glucose tolerance (IGT) to normal glucose tolerance (NGT) in China. IGT is a primary cause of T2D, and there are approximately 500 million IGT patients worldwide. The main cause of IGT, especially those with impaired post-prandial glucose tolerance, is the impairment of early-phase insulin secretion in the pancreas and the defect of glucokinase expression in the liver. Mechanistically dorzagliatin has the potential of reversing the condition of the IGT to NGT, and thereby preventing diabetes.

Business Outlook

• The Company will continue with our responsibility as market authorization holder (MAH) of dorzagliatin to commercialize dorzagliatin in China with our partner, Bayer, to expand market share in diabetes care, especially among Type 2 diabetes patients with uncontrolled postprandial glucose (PPG) who will benefit from the improvement of beta cell function and time in range (TIR).
• The Company will continue to invest in dorzagliatin manufacturing capability and into expanding our tier-1 distributor network to drive a three-pronged approach to commercialization in China: hospitals, pharmacies, and online drug stores.
• The Company is seeking entry into the National Reimbursement Drug List (NRDL), to facilitate entry into hospitals and increase accessibility by physicians in order to demonstrate dorzagliatin’s potential to be a cornerstone treatment for Type 2 diabetes as monotherapy or in combination with other approved antidiabetic drugs.
• The Company is expecting to receive a certain milestone payment from Bayer related to the development of dorzagliatin in the second half of 2023.
• The Company is also advancing the development of our second generation glucokinase activator for potential future international expansion including DKD and diseases associated with impaired glucose homeostasis. Currently, we are actively looking for business partners to advance our R&D programs and commercialization to help more patients globally.
• The Company will continue to develop new drug candidates for fixed-dose-combination of dorzagliatin with metformin, sitagliptin (a DPP-4 inhibitor) and empagliflozin (a SGLT-2 inhibitor). It was found in clinical studies that the combination of dorzagliatin with a DPP-4 inhibitor or SGLT-2 inhibitor improved glycaemic control and beta cell function in patients with diabetes and obesity.
• Additional benefits of dorzagliatin in disease prevention will be further explored in endocrinology and neurodegeneration.
• Progress has been made in glucokinase candidate targeting congenital hyperinsulinism a rare disease in the United States and China. The AI-based lead optimization will help to advance the program and select clinical candidates with a joint effort at AscendRare and Hua Medicine. We are also jointly investigating the opportunity of FKI in different disease areas and developing sensitive IVD methods for the clinical detection of fructose, a sugar component, which contributes to obesity and liver disease. Reduction of the fructose flux into the liver could prevent fatty liver disease and related complications.

Financial highlights

• As of June 30, 2023,
• Since the launch of commercial sales at the end of October 2022, dorzagliatin achieved a total sales revenue of RMB87.9 million as of June 30, 2023. The revenue of Hua Medicine for the first half of 2023 was RMB70.3 million, which was an increase of approximately 299.6% compared to the second half of 2022.
• Bank balances and cash position were approximately RMB881.3 million.
• Total expenditures incurred by the Company for the six months ended June 30, 2023, were approximately RMB181.5 million, of which approximately RMB71 million was attributable to research and development expenses.
• Total comprehensive expenses for the period decreased by approximately RMB14.0 million or approximately 13.4% to approximately RMB90.5 million, compared with the six months ended June 30, 2022.

Forward-looking Statement
This article contains statements regarding the future expectations, plans and prospects for Hua Medicine and the investigational product. The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect as a result of various risks, uncertainties, or other legal requirements.

About Hua Medicine
Hua Medicine is an innovative drug development and commercialization company based in Shanghai, China, focused on developing novel therapies for patients worldwide with unmet medical needs. Based on global resources, Hua Medicine teams up with global high-caliber people to develop breakthrough technologies and products, which contribute a global innovation in diabetes care. As Hua Medicine’s cornerstone product (dorzagliatin tablets), targeting the glucose sensor, glucokinase, restores glucose sensitivity in T2D patients and stabilizes the imbalance of blood glucose levels in patients, it has been approved by the National Medical Products Administration (NMPA) of China on September 30th, 2022. It can be used alone or in combination with metformin hydrochloride-tolerated T2D patients. For patients with chronic kidney disease (CKD) and Type 2 diabetes (i.e., diabetes kidney disease), no dose adjustment is required. Hua Medicine will partner with Bayer, a leading global pharmaceutical company, to commercialize HuaTangNing in China, benefiting diabetic patients and their families. HuaTangNing has also demonstrated its potential to achieve diabetes remission in clinical studies to help millions of diabetic patients around the world.

Disclaimer
For the accuracy and completeness of the context, references to information related to products launched in China, especially labels or requirements, should follow the relevant documents approved by the Chinese regulatory authorities.

The above information should not be interpreted as a recommendation or promotion of any drug or treatment regimen, nor should it substitute for the medical advice of any healthcare professional. Please consult a healthcare professional for any matters related to medical treatment.