About HUA MEDICINE-B Company

Hualing Pharmaceutical is a Chinese drug development company currently dedicated to developing the world's first novel 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 nature of diabetes by restoring glucose homeostasis 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 a basic treatment in combination with currently approved antidiabetic drugs. Our phase I and phase II clinical trials showed proof of concept, and participants showed significant decreases 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 in 258 patients with type 2 diabetes in China showed that Dorzagliatin reduced HbA1c in the 75 mg group twice daily by 1.12%, and we used the same dose in the phase III clinical trial. In this group, 44.9% of patients had their blood sugar under control (HbA1c levels measured at week 12 were lower than 7.0%), and 75.0% of patients had HbA1c falling more than 10% from baseline levels at week 12. Furthermore, based on the following three clinical endpoints: (i) glycemic control with HbA1c levels below 7.0%; (ii) no weight gain; and (iii) no hypoglycemia (dangerous low blood sugar levels), 35.4% of patients reached a composite endpoint. The results of the phase II clinical trial demonstrated the effect of restoring steady glucose balance. Even after only 12 weeks of administration with Dorzagliatin, a relatively high percentage (35.4%) of patients had reached the composite endpoint, and a relatively high percentage (75.0%) of patients had their HbA1c levels reduced by more than 10% from baseline. Coupled with improvements in beta-cell function and decreased insulin resistance that continued to work at the end of week 13 (one week after the end of the phase II clinical trial), these results together showed significant improvements compared to currently available antidiabetic drugs, and showed differentiated efficacy in improving the course of the disease.