March 1, 2019, Shanghai
Hua Medicine (HKEX: 2552), a Shanghai-based drug development company focused on developing a global first-in-class oral drug for the treatment of Type 2 diabetes, announced today the completion of patient enrollment for a Phase III monotherapy trial of HMS5552 (dorzagliatin). Hua Medicine therefore expects to release the topline results in 4th quarter of 2019.
“I am very proud to announce this milestone,” said Dr. Li Chen, Chief Executive Officer of Hua Medicine. “With 120 million Type 2 diabetics in China, this gets us one step closer to bringing dorzagliatin, a novel, first-in-class drug to the Chinese market. Dorzagliatin will be a 3rd generation T2D drug, as it has the opportunity to stop the progression of T2D, which has not been possible with existing drugs on the market. The protocol follows our Phase II study design, which demonstrated strong safety and efficacy data, with promising disease modifying effects.”
The Phase III monotherapy registration trial targets drug naïve T2D patients, positioning dorzagliatin as first-line therapy. The monotherapy trial is a double-blind, placebo-controlled study and patients are randomized 2:1 to receive either dorzagliatin or placebo. The clinical study evaluates the efficacy and safety of dorzagliatin with 24 weeks of double-blinded treatment plus 28-week open-label treatment, and follow-up. The trial is being conducted in 40 clinical sites across China.
Dorzagliatin is a first-in-class glucokinase activator, or GKA, designed to control the progressive degenerative nature of diabetes by restoring glucose homeostasis in Type 2 diabetics. Hua Medicine in-licensed the global rights to dorzagliatin from Roche. By addressing the defect of the glucose sensor function of glucokinase, or GK, dorzagliatin has the potential to repair the impaired glucose homeostasis state of Type 2 diabetics and serve as a first-line standard of care therapy for the treatment of Type 2 diabetes, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs.
Hua is a leading, clinical stage innovative drug development company in China focused on novel therapies for the treatment of diabetes. Founded by an experienced group of entrepreneurs and international investment firms, Hua advanced a first-in-class oral drug for the treatment of Type 2 diabetes into NDA enabling stage and started 2 Phase III trials in China. The Company has also initiated product life-cycle management studies of this novel diabetes drug, and advanced its use in personalized diabetes care. Hua's strategy is to leverage the cost-efficient and high-quality drug development capabilities available in China, while working very closely with disease experts and regulatory agencies in China and rest of the world to advance diabetes care solutions for global patients.
For more information:
Emily Yeh, Director of Corporate Finance