Hua Medicine announced 24-week top-line results from HMM0301 [NCT03173391], the first Phase III trial of a novel first-in-class dual-acting glucokinase (GK) activator, dorzagliatin (HMS5552), which was designed to restore glucose homeostasis in adults with type 2 diabetes. Hua Medicine is currently conducting two pivotal 52-week Phase III trials in China (dorzagliatin as a monotherapy and in combination with metformin), each with an initial 24-week double blinded, placebo-controlled treatment, followed by an open label 28-week treatment in which all patients receive dorzagliatin. In this HMM0301 trial, Chinese drug-naïve Type 2 diabetes patients received 75 mg of dorzagliatin or placebo (randomized 2:1) twice per day and were monitored every four weeks during the first 24-weeks for efficacy and safety outcomes. The subsequent 28-week treatment period is ongoing. The trial achieved its primary efficacy endpoint by demonstrating a statistically significant reduction in HbA1c levels over placebo during the first 24 weeks of the trial. Patients treated with dorzagliatin achieved 1.07% HbA1c reduction from baseline of 8.35% at 24 weeks compared to a reduction of 0.50% from a baseline of 8.37% in patients who received placebo (Least square mean, p-value less than 0.0001). The American Diabetes Association (ADA) treatment target of HbA1c below 7.0% was achieved by 45.4% of subjects on dorzagliatin (PPS data, p-value less than 0.0001), compared to 21.5% of subjects who received placebo. The homeostatic control rate, measured by the percentage of Type 2 diabetes patients who achieved an HbA1c level of below 7.0% without hypoglycemia, reached 45.0% in subjects on dorzagliatin (PPS data, p-value less than 0.0001), and 21.5% in subjects on placebo. HMM0301 study design: HMM0301 [NCT03173391] is a randomized, double-blind, placebo-controlled Phase III study in 463 drug naïve type 2 diabetes patients. Patients are treated with twice-daily doses of dorzagliatin (75 mg) or placebo, randomized 2:1. The clinical study evaluates the efficacy and safety of dorzagliatin during 24 weeks of double-blinded treatment, followed by a subsequent 28-week open-label treatment period, for a total of 52 weeks. The trial was conducted in compliance with the guidelines of the Chinese Society of Endocrinology, which require physicians to educate patients and strictly enforce improved exercise and dietary control, as well as continuous self-monitoring, in treating type 2 diabetes. The primary efficacy endpoint is evaluated at the conclusion of the first 24 weeks. The trial is being conducted at 40 clinical sites across China led by Professor Dalong Zhu, President of the Chinese Diabetes Society. Hua Medicine expects to release 52-week data in the second quarter of 2020. Hua Medicine cannot guarantee that it will release its 52 week data in the second quarter of 2020 or it will be able to develop or ultimately market, dorzagliatin successfully. Shareholders and potential investors of Hua Medicine are advised to exercise due care when dealing the shares of Hua Medicine.