Hua领 Pharmaceuticals Announces Approval of First-in-Class Glucokinase Activator HuaTangNing® (Dorzagliatin) in China for Type 2 Diabetes
Hua Medicine (“the Company”, Hong Kong Stock Exchange stock code: 2552.HK) announced today that Hua Tang Ning, a global first-in-class new drug, glucose kinase activator (GKA), developed by the Company®(Dorzagliatin Tablets, dorzagliatin, HMS5552) received marketing approval from the China National Medical Products Administration (NMPA) on October 8. Huatangning®Approved for two indications: as monotherapy for treatment-naïve patients with type 2 diabetes, or in combination with metformin for adults with type 2 diabetes who have inadequate glycemic control on metformin alone. No dose adjustment is required for patients with renal impairment, making it an oral antihyperglycemic agent suitable for patients with type 2 diabetes and moderate to end-stage renal disease. Meanwhile, clinical trials have demonstrated that Huatangning®Combination therapy with empagliflozin (an SGLT2 inhibitor) and sitagliptin (a DPP-4 inhibitor) demonstrates superior efficacy compared to monotherapy, offering the potential for improved glycemic control and pancreatic islet function in patients with type 2 diabetes.
Hua Tang Ning®Huatangning is the first glucokinase activator approved for marketing worldwide, the first original new drug with a novel mechanism in the field of diabetes in the past decade, and the first global first-in-class innovative drug for type 2 diabetes launched in China. This milestone represents significant progress in addressing the clinical needs of Chinese patients through advanced innovative scientific concepts within China’s biopharmaceutical industry. Huatangning®It is the first global first-in-class new drug developed by Hua Medicine using the operational model of “integrating Chinese and Western approaches, collaborative innovation, and shared success,” marking a new historical phase in China’s leadership in pharmaceutical innovation.
Huatingning®Huatangning is a global first-in-class innovative drug independently developed by Hua Medicine, adhering to its mission of “patients first, innovation-based, and quality medicines for the people,” and tailored to the disease characteristics of diabetic patients in China.®Since its inception, the R&D project has garnered significant attention and recognition from the new drug development industry and national drug review and approval authorities, being consecutively selected for the National Ministry of Science and Technology’s “12th Five-Year” and “13th Five-Year” Major New Drug Creation Special Projects. Huatangning®Characterized by the “Five New” attributes—novel concept, new mechanism, new structure, new technology, and new therapeutic efficacy—the entire development process, from preclinical studies through Phase I, II, and III clinical trials, was led and designed by Chinese R&D teams and clinical investigators. This achievement not only marks a significant breakthrough in translating innovative concepts into innovative products but also establishes a viable pathway for independent research and development of global first-in-class drugs in China. Huatangning®The successful approval also signifies that, after more than two decades of development by numerous pharmaceutical companies both domestically and internationally, the world’s first approved glucokinase activator (GKA) has finally emerged, marking a breakthrough from zero. Following its market launch, Hua Medicine will collaborate with industry leader Bayer to jointly promote Huatangning.®Commercial promotion in China, to benefit patients with diabetes and their families.
Globally, the incidence of diabetes continues to rise. The latest data from the International Diabetes Federation (IDF) shows that in 2021, the number of adults with diabetes worldwide reached 537 million, an increase of 74 million, or 16%, compared to 2019. In 2021, global health expenditures attributable to diabetes and its complications amounted to approximately USD 966 billion. The situation regarding diabetes prevention and control in China is also concerning; by 2021, the number of people with diabetes had reached 140 million, among whom approximately 72.83 million remained undiagnosed and untreated, representing a high proportion of 51.7%. Meanwhile, significant fluctuations in blood glucose levels among patients with diabetes have led to a series of complications, including cardiovascular and cerebrovascular diseases, nephropathy, retinopathy, and diabetic foot, which greatly affect patients’ survival needs and quality of life, imposing a heavy disease burden on patients and their families. Therefore, improving glycemic homeostasis and maintaining a high Time in Range (TIR) has become an important goal in the treatment and management of type 2 diabetes. According to the Notice on the 14th Five-Year Plan for National Health issued by the General Office of the State Council, enhancing comprehensive prevention and control capabilities for major chronic diseases such as diabetes will continue to be a key health priority for the nation. It is expected that during the 14th Five-Year Plan period, the rate of standardized grassroots management services for patients with type 2 diabetes will exceed 65%. Huatangning®Its successful approval and market launch align with the national strategy of advancing China’s pharmaceutical industry and improving the health status of its population.
The rapidly growing number of patients with diabetes and the substantial market capacity for diabetes medications both indicate unmet medical needs in the field of diabetes. Guided by the original scientific concept of “repairing sensing, restoring homeostasis, and treating diabetes at its source,” Hua Medicine has directly targeted the root cause of dysfunctional glucose sensors in patients with type 2 diabetes and successfully developed Huatangning.®This global first-in-class new drug. Clinical studies have shown that Huatangning®It can restore the impaired function of glucokinase sensors in diabetic patients, improve their ability to autonomously regulate blood glucose levels, and is expected to control the progression of type 2 diabetes and the occurrence of complications at the source.
As a novel class of type 2 diabetes therapeutics, Huatangning®The development has also garnered sustained attention from the international academic community. In 2018, the results of its Phase II clinical trial were published in the prestigious international medical journal The Lancet Diabetes & Endocrinology, marking the first time the journal had published clinical research findings on an original new drug for type 2 diabetes originating from China. This May, two peer-reviewed articles detailing the results of its Phase III trials were simultaneously published in the top-tier international medical journal Nature Medicine. These papers respectively presented and described in detail the clinical outcomes of monotherapy (the SEED study) and combination therapy with metformin (the DAWN study) for type 2 diabetes, fully affirming Huatangning.®As a novel antidiabetic agent with a new mechanism of action, it offers significant safety advantages and possesses mechanistic characteristics that improve pancreatic islet function in patients with type 2 diabetes, highlighting Huatangning.®Demonstrated unique advantages in patients with diabetic nephropathy in clinical trials.
Other clinical study data also indicate that Huatangning®Combination therapy with DPP-4 inhibitors and SGLT-2 inhibitors has demonstrated significant synergistic efficacy in glycemic control, with a favorable safety profile. It holds broad application potential for patients with type 2 diabetes across varying glycemic control needs and disease stages, and is expected to become an important approach to achieving diabetes remission by restoring early-phase insulin secretion and sustainably improving β-cell function. In the future, Hua Medicine will continue to explore Huatangning (Dorzagliatin).®Its potential in achieving drug-free remission of type 2 diabetes and in combination therapy with the nine existing classes of antidiabetic agents, striving to meet major societal needs for diabetes prevention, remission, and delay of complications, while bringing Chinese innovations to the global market.
Ms. Zhou Xiaolan, Global Executive Vice President of Bayer’s Pharmaceuticals Division and President of Bayer China, as well as President of Bayer Greater China, stated: “Bayer has been deeply committed to the field of diabetes treatment, supporting the development of diabetes prevention and control in China. Huatangning”®with Glucobay®—as the first oral antidiabetic drug with an indication for impaired glucose tolerance (IGT), together with continuous glucose monitoring systems (CGMs), it establishes a comprehensive disease management pathway spanning from prevention to treatment for Chinese patients with type 2 diabetes, and achieves the goal of “stable glucose lowering” through real-time blood glucose monitoring; meanwhile, Bayer will actively explore digital solutions to help hundreds of millions of patients in China realize the vision of living free from the burden of diabetes at an earlier stage.”
Dr. Chen Li, Founder, Chief Executive Officer, and Chief Scientific Officer of Hua Medicine, stated: “Hua Tang Ning®The successful approval marks a significant milestone for Hua Medicine and signals that China’s innovative drug industry has entered a new stage of development. The chronic disease management of diabetes is a major strategic issue concerning national welfare and people’s livelihood. Adhering to its original aspiration of “China Leading Pharmaceutical Innovation,” Hua Medicine has worked diligently for ten years amidst fierce international competition to achieve a breakthrough from zero. Together with its researchers and partners, the company has developed this first-in-class, China-first novel diabetes medication. This is all participants in Huatangning®A joint achievement of Chinese scientists, clinicians, and collaborators involved in the research and development, we regard Huatangning®I am very proud of the approval and market launch, and I would also like to express my sincere gratitude to everyone for their support of Huatangning.®the arduous efforts and wholehearted dedication that led to its approval and market launch. Meanwhile, Hua Medicine looks forward to deep integration with Bayer, unleashing full vitality to comprehensively accelerate the development of Huatangning®commercialization process, bringing new hope for diabetes prevention, treatment, and remission to hundreds of millions of diabetic patients in China, raising the standards for diabetes prevention and control, and contributing to the national strategy of Healthy China 2030.”
Hua Tang Ning®(Dorzagliatin Tablets) is a first-in-class glucose kinase activator with a novel mechanism and allosteric modulatory function, used as monotherapy or in combination with metformin hydrochloride when glycemic control is inadequate with metformin hydrochloride alone, to improve glycemic control in adult patients with type 2 diabetes mellitus, along with diet and exercise. Huatangning®Huatangning holds promise for achieving multi-target, coordinated glycemic control by restoring impaired glucokinase function in the pancreas, intestine, and liver. It can glucose-dependently regulate the secretion of glycemic hormones—including insulin, GLP-1, and glucagon—thereby improving early-phase insulin secretion and the disposition index in patients with diabetes, demonstrating potential to restore glucose homeostasis and achieve drug-free remission of diabetes. Huatangning®Huatangning demonstrated significant glucose-lowering effects in two Phase III registration clinical trials, both as monotherapy and in combination with metformin. It effectively reduced postprandial blood glucose levels, with a low risk of hypoglycemia and favorable safety and tolerability.®Huatangning exhibits a linear relationship between drug dose and systemic exposure, with target organ distribution in the pancreas, intestine, and liver. Renal excretion is low, and its pharmacokinetic profile is similar in patients with end-stage renal disease (ESRD) and healthy subjects; therefore, no dose adjustment is required for patients with renal impairment.®Its unique mechanism of action, favorable pharmacokinetic profile, and good safety and tolerability make it a novel class of diabetes therapeutics.
Hua Medicine is an innovative drug development company founded in China, dedicated to addressing unmet medical needs and developing novel therapies for patients worldwide. By bringing together top-tier talent from the global pharmaceutical industry, integrating cutting-edge international technologies, and leveraging global strategic resources, Hua Medicine researches and develops breakthrough technologies and products, leading innovation in diabetes care globally. Its core product, Huatangning®(Dorzagliatin Tablets) targets the glucose sensor glucokinase to enhance glucose sensitivity in patients with type 2 diabetes. It has completed two Phase III registration trials in China—the SEED study and the DAWN study—and has officially received new drug marketing approval from the National Medical Products Administration (NMPA) of China. As the world’s first-in-class glucokinase activator, it has demonstrated the potential for diabetes remission in clinical studies, aiming to benefit hundreds of millions of diabetes patients worldwide.
As a multinational enterprise, Bayer possesses core competencies in the health and agriculture sectors of life sciences. The company is committed to helping people overcome the major challenges posed by global population growth and aging through its products and services, thereby contributing to human well-being and the prosperity of the planet. Bayer is dedicated to promoting sustainable development and generating a positive impact through its business operations. Meanwhile, the Group enhances profitability and creates value through technological innovation and business growth. Worldwide, the Bayer brand stands for trust, reliability, and quality. In the 2020 fiscal year, Bayer employed approximately 100,000 people and reported sales of €41.4 billion. Research and development expenditures, excluding special items, amounted to €4.9 billion. For more information, please visit www.bayer.com.
In August 2020, Bayer, a multinational pharmaceutical company, and Hua Medicine, a Chinese innovative drug R&D company, announced a strategic partnership in China regarding dorzagliatin, a novel first-in-class diabetes treatment. This collaboration aims to leverage Bayer’s extensive strengths in diabetes management in China and Hua Medicine’s R&D expertise in the field of diabetes, combining their efforts to provide new therapeutic options and benefit hundreds of millions of diabetes patients in China. Under the agreement, Hua Medicine, as the Marketing Authorization Holder (MAH), will be responsible for clinical trials, drug registration, supply, and distribution; Bayer, as the promotional services provider, will handle marketing, promotion, and medical education activities for the product in China. The collaboration was facilitated by the Bayer Prescription Drugs China Collaboration Innovation Center. As a global leader in the pharmaceutical industry, Bayer is committed to working with external partners to drive breakthrough innovations, bring positive changes to patient health, and achieve its goal of “Co-creating Innovation, Healing Together.”