Hua Medicine (Stock Code: 2552.HK), today announced that the New Drug Application (NDA) for dorzagliatin for the treatment of Type 2 Diabetes (T2D) was accepted by the China National Medical Products Administration (NMPA).
Dorzagliatin is the first glucokinase activator (GKA) to submit a NDA for the treatment of diabetes, and has the potential to become the first first-in-class drug to be launched in China.
Relying on Hua Medicine’s original scientific concept of “repair the sensor, restore homeostasis, and treat the underlying cause of diabetes,” the Company has always focused on addressing unmet medical needs since its establishment. The Company is committed to developing breakthrough products with innovative concepts, and advancing and establishing clinical practice and treatment standards globally. Dorzagliatin is the world’s first new GKA diabetes drug for which a NDA has been submitted, with a new mechanism of action, new targets, new structures, new formulations and new curative effects. Dorzagliatin is the world’s first new oral treatment for diabetes launched by a Chinese biotechnology company. Its mechanism of action directly targets the underlying cause of T2D. By repairing the damaged glucokinase sensor function in diabetic patients, dorzagliatin can significantly improve the beta-cell function and reduce insulin resistance in patients with T2D, effectively control the progress of T2D, and has therapeutic prospects in patients with diabetic nephropathy.
Today, diabetes is a major public health problem. According to a survey published by the British Medical Journal (BMJ) in 2020, based on the diagnostic criteria of the American Diabetes Association (ADA), the total number of diabetic patients in China is approximately 130 million. Compared with the large number of patients, the diagnosis rate of T2D in China is only 43.3%, and the treatment rate is only 49.0%. In recent years, China has emphasized the importance of prevention and treatment of diabetes. The “Healthy China Action (2019-2030)” has clearly defined the goal. By 2030, the diagnosis rate of diabetes among citizens aged 18 and above will reach above 60%, and the standardized management rate will reach above 70%. The diabetes treatment rate, control rate and complication screening rate is expected to continue to increase.
In the past ten years, the global diabetes market has grown rapidly. In 2019, the global expenditures spent on diabetes was approximately 760 billion USD, and the spending in China alone is approximately 109 billion USD. The market potential is exceptionally large. With the successive launches of the China Type 2 Diabetes Prevention and Treatment Guide (2020 Edition) by the Chinese Diabetes Society and the ADA’s Diabetes Diagnosis and Treatment Pathway (2021 Edition), the concept of “glucose homeostasis” has become the standard for treatment of diabetes. The development of glucokinase activator for “glucose homeostasis” as the core has also attracted attention.
In December 2020, Hua Medicine announced that it has successfully completed two Phase III registration trials of dorzagliatin, of which SEED (HMM0301) is a monotherapy trial in drug naive T2D patients, and DAWN (HMM0302) is a trial of dorzagliatin combined with metformin in T2D patients who are metformin-tolerant. The two trials demonstrated fast onset, potent, and sustained HbA1c reduction, and significantly reduced 2H-PPG. Dorzagliatin also demonstrated good safety and tolerability, improved beta-cell function and reduced insulin resistance. Two Phase I clinical studies conducted in the first half of 2020 showed that the combination of dorzagliatin with sitagliptin (a DPP-4 inhibitor) and empagliflozin (a SGLT-2 inhibitor) showed a significant synergistic effect in blood glucose control, indicating that dorzagliatin has broad application potential in T2D patients with different glucose control needs at different disease stages. Another Phase I study conducted in patients with end-stage renal impairment showed that dozagliflozin monotherapy can provide treatment opportunities for diabetic nephropathy (DKD), which accounts for about 20%-40% of the T2D population. It has potential to become a hypoglycemic agent for diabetic nephropathy without dosage adjustment.
In the process of preparing for the commercialization of dorzagliatin, in August 2020, Hua Medicine formed a strategic cooperation agreement in China with the global pharmaceutical giant and leader in Chinese diabetes treatment, Bayer. Hua Medicine’s innovative capabilities and Bayer’s leading advantage in the field of diabetes management in China will enable this world’s first innovative drug to benefit Chinese diabetic patients as soon as possible. In September 2020, the Company received the “Drug Manufacturing Permit” for dorzagliatin from the Shanghai Drug Administration, completing the core work of preparation for commercial production.
Dr. Li Chen, founder and CEO of Hua Medicine, said: “We are very pleased that dorzagliatin’s NDA application has been accepted by the NMPA. This is a major milestone for Hua Medicine. On the path to first-in-class, first-in-China, Hua Medicine has always strived to stand at the forefront of reform and pharmaceutical innovation, and contribute to the development of China’s pharmaceutical industry and its people’s health. Diabetes chronic disease management is a major work to protect national health, For the past 10 years Hua Medicine has committed to “China Leading Pharmaceutical Innovation”, and actively explored the development and review and approval of China’s first innovative drug with the Drug Evaluation Center, and achieved significant achievements in the field of innovative drug development with the spirit of “a sword in ten years.” We have achieved breakthrough and developed this global innovative drug, allowing China to join the world in first-in-class drug development. We are very proud of this achievement and we look forward to working with our partners to jointly promote dorzagliatin in China.”
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive, degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired glucose homeostasis state of patients with Type 2 diabetes and serve as a first-line standard-of-care therapy for the treatment of the disease, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs. Two Phase III registration trials for dorzagliatin have been completed in China. The Company has obtained the “Drug Manufacturing Permit” of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and has submitted the NDA for dorzagliatin to the National Medical Products Administration, so as to realize the “First in Global, Start from China” mission objective for the benefit of diabetic patients worldwide.
About Hua Medicine
Hua Medicine is a leading, innovative biotechnology company in China focused on developing novel therapies for diseases with unmet medical needs. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM into NDA stage and it has successfully completed two Phase III registration trials in China for dorzagliatin. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.
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