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Hua Medicine completes patient enrollment for Phase III combination with metformin trial of dorzagliatin

– 2019-08-30
August 30, 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 combination trial of HMS5552 (dorzagliatin) add on to metformin. Hua Medicine therefore expects to release the topline results of such trial in the second quarter of 2020.

"I am very excited to announce this milestone," said Dr. Li Chen, Chief Executive Officer of Hua Medicine. "We intend to become a global diabetes care company driven by our dorzagliatin-focused portfolio, with dorzagliatin serving as a cornerstone therapy for the treatment of diabetes, which could fix the glucose sensor and restores glucose homeostasis. The completion of enrollment for our second registration trial is a significant milestone in bringing dorzagliatin to the global market. Metformin is the most commonly used therapy for T2D treatment and has had long clinical application for more than 60 years. Combination with dorzagliatin for treatment of patients who are metformin tolerant could bring new hope to stopping diabetes in those patients."

The Phase III dorzagliatin combination with metformin registration trial targets metformin-tolerated T2D patients. The combination trial is a double-blinded, placebo-controlled study and patients are randomized 1:1 to receive either metformin alone or dorzagliatin combined with metformin. The clinical study evaluates the efficacy and safety of dorzagliatin during 24 weeks of double-blinded treatment plus 28-week open-label treatment, with the primary efficacy endpoint evaluated at 24 weeks. The trial is being conducted in over 70 clinical sites across China led by Professor Wenying Yang of the China-Japan Friendship Hospital. In an earlier Phase I trial, the combination of dorzagliatin and metformin demonstrated superior clinical efficacy to metformin alone, and this study also demonstrated a good safety profile.

About Dorzagliatin

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. 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.

About Hua Medicine

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.

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