About HUA MEDICINE-B Company

Hualing Pharmaceutical is a Chinese drug development company currently working to develop the world's first innovative oral drug, Dorzagliatin, or HMS5552, for the treatment of type 2 diabetes. Dorzagliatin is a glucokinase activator, or GKA, designed to control the progressive degenerative properties of diabetes by restoring glucose homeostatic balance in type 2 diabetics. By addressing the glucose-sensing function of glucokinase (or GK), we believe Dorzagliatin may become the first-line standard treatment for type 2 diabetes, either as a monotherapy or as basic treatment in combination with currently approved antidiabetic drugs. Our phase I and phase II clinical trials showed a proof of concept. Participants clinically showed significant reductions in blood sugar and glycated hemoglobin (or Hb1Ac) levels when beta cell function in the pancreas was enhanced and insulin resistance decreased. A 12-week trial of 258 patients with type 2 diabetes in China showed that Dorzagliatin reduced HbA1c by 1.12% in the 75-mg group twice daily; we used the same dose in the phase III clinical trial. In this group, 44.9% of patients had blood sugar controlled (HbA1c levels measured below 7.0% at week 12), and 75.0% of patients had HbA1c drop by 10% or more from baseline levels at week 12. Additionally, 35.4% of patients reached the composite end point based on the following three clinical endpoints: (i) glycemic control with HbA1c levels below 7.0%; (ii) no weight gain; and (iii) no hypoglycemia (dangerously low blood sugar levels). The results of the phase II clinical trial demonstrated the effect of restoring glucose homeostasis. Even when Dorzagliatin was given for only 12 weeks, a relatively high percentage (35.4%) of patients reached the composite end point, and a relatively high percentage (75.0%) of patients had HbA1c levels reduced by more than 10% from baseline. Coupled with improved beta cell function and reduced insulin resistance that continued to work at the end of week 13 (one week after the end of phase II clinical trials), these results showed a significant improvement compared to currently available antidiabetic drugs, and showed differentiated efficacy in improving the course of the disease.