May 31, 2021 - China, Shanghai
Hua Medicine (the "Company", Stock Code: 2552.HK), today announced that the Company will present additional clinical research analysis data of its world's first new drug, glucokinase activator (GKA) dorzagliatin, at the 81st American Diabetes Association (ADA) Annual Scientific Sessions. The ADA Annual Scientific Sessions will be held online from June 25 to 29, 2021.
In the first half of 2020, Hua Medicine successfully completed two clinical studies, HMM0111 and HMM0112, dorzagliatin in combination with sitagliptin (a DPP-4 inhibitor) and empagliflozin (a SGLT-2 inhibitor) respectively. Both trials demonstrated clear synergistic effects in blood glucose control, indicating that dorzagliatin has a wide range of application potential in Type 2 diabetes ("T2D") patients with different glucose control needs and at different disease stages.
At the ADA Annual Scientific Sessions, Hua Medicine will release the latest analysis data from the two studies. The highlights of the report include:
● | Dorzagliatin administered in combination with sitagliptin can regulate GLP-1 release in T2D patients. GLP-1 is an important hormone in glycolipid metabolism, and GLP-1 receptor agonists is an important drug for the treatment of diabetes. | |
● | Dorzagliatin is synergistic with sitagliptin or empagliflozin in improving blood glucose reduction and optimizing the islet β-cell function of T2D patients, improving patients’ insulin secretion. | |
● | Dorzagliatin demonstrated good safety and was well tolerated when administered alone and when administered together with sitagliptin or empagliflozin. |
Hua Medicine will present a more detailed data analysis of the above research results at the ADA Annual Scientific Sessions.
About Dorzagliatin
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 insulin and GLP-1 secretion of patients with Type 2 diabetes and serve as a cornerstone therapy targeting the root cause of the disease. Two Phase III registration trials for dorzagliatin monotherapy and the combination of dorzagliatin and metformin have been completed in China, as well as studies on drug mechanism synergy with sitagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2). The Company has obtained the “Drug Manufacturing Permit” of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and has submited its NDA 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-enabling 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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