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January 31, 2019

Hua Medicine Initiates First Combination Study of Dorzagliatin with a DPP-4 Inhibitor in the United States

SHANGHAI, China, Jan. 31, 2019 (GLOBE NEWSWIRE) — Hua Medicine (“Hua” or “the Company”; Stock Code: 2552.HK) a Shanghai-based drug development company focused on developing a global first-in-class oral drug for the treatment of Type 2 diabetes (T2D), announced today dosing of the first patient in a clinical trial of HMS5552 (dorzagliatin) in patients with insufficiently controlled blood glucose levels with metformin, DPP-4 inhibitor, or SGLT-2 inhibitor, alone or in combination therapy. The trial is a pharmacokinetic (PK) and pharmacodynamic (PD) study of dorzagliatin in combination with sitagliptin to investigate the PK/PD of each drug alone or in combination. The primary endpoints are pharmacokinetic and pharmacodynamic interaction between dorzagliatin and sitagliptin, and safety and tolerability of dorzagliatin with simultaneous administration of sitagliptin. This trial is conducted in the United States.

 “Current T2D treatment follows medical practices guidelines and addresses patients as if they are the same,” said Dr. Li Chen, Chief Executive Officer of Hua Medicine. “With 435 million T2D patients globally, it is important to classify Type 2 diabetics to provide tailored prescriptions that result in better efficacy, improved safety, and reduced complications. The clinical study of dorzagliatin with DPP-4 inhibitor allows us to validate the synergy of both mechanisms of action, and take the next step in establishing dorzagliatin as a cornerstone therapy for T2D.”

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.

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