Hua Medicine Initiates First Combination Study of Dorzagliatin with SGLT-2 in the United States

SHANGHAI, China, April 22, 2019 (GLOBE NEWSWIRE) -- 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 dosing of the first patient in a Phase I drug-drug interaction trial of HMS5552 (dorzagliatin) in patients with insufficiently controlled T2D with metformin, DPP-4 inhibitor, or SGLT2 inhibitor, alone or in combination therapy (metformin plus DPP-4 inhibitor, or metformin plus SGLT-2 inhibitor). The trial is a pharmacokinetic and pharmacodynamic study of dorzagliatin in combination with empagliflozin to investigate the PK/PD of each drug alone or in combination. The primary endpoints are pharmacokinetic interaction between dorzagliatin and empagliflozin, and safety and tolerability of dorzagliatin with simultaneous administration of empagliflozin. The trial is conducted in the United States.

“We are very pleased to see the combination study of dorzagliatin with empagliflozin started in US,” said Dr. Li Chen, Chief Executive Officer of Hua Medicine. “These two medicines work through different mechanism in the glycemic control in the type 2 diabetes and have the potential to provide a synergy to treat T2D patients with metabolic syndrome.”

There are 435 million individuals with T2D globally, with a diagnosis rate of 54.2%. Diabetes imposes a large economic burden on the global healthcare system, costing US$850 billion globally in 2017. Currently approved diabetes therapies cannot effectively control the progression of diabetics into more advanced stages of the diseases, which then leads to the many complications associated with severe diabetes, such as loss of vision, peripheral neuropathy, impaired kidney function, cardiovascular disease, and stroke.

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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Emily Yeh, Director of Corporate Finance