Hua Medicine Announces 2020 Interim Results

August 17, 2020 – Shanghai, China

Hua Medicine (the"Company", Stock Code: 2552.HK), a global innovative drug research and development company focused on the novel therapies for the treatment of Type 2 Diabetes ("T2D"), today announces the consolidated results of the Company and its subsidiaries for the six months ended June 30, 2020 (the"Reporting Period"). During the Reporting Period, the Company incurred approximately RMB 180.5 million in total expenditures, and approximately RMB 112.3 million was attributable to research and development expenses. The Company incurred loss before tax of RMB 173.5 million, which decreased by RMB 62 million, approximately 26.3% compared with the six months ended June 30, 2019. As of June 30, 2020, the Company’s cash position was approximately RMB 949.6 million.

The first half of 2020 was of extraordinary significance for Hua Medicine, during which the Company made many key developments. The Company’s investigational first-in-class drug dorzagliatin, a novel glucokinase activator (GKA), is the first to complete a Phase III registration trial in drug-naïve T2D patients, making Hua Medicine the first company globally to successfully accomplish the clinical development of GKA. As demonstrated in clinical trials, dorzagliatin has the potential to repair the impaired glucose sensor function of glucokinase, improve the function of β-cells, promote early-phase insulin secretion, and reduce insulin resistance, thereby effectively and sustainably improving the blood glucose level of T2D patients. Furthermore, dorzagliatin has the potential to promote the autonomous regulation of blood glucose levels and restore glucose homeostasis. Hua Medicine’s other ongoing Phase III trial, dorzagliatin in combination with metformin has also achieved primary efficacy and safety endpoints at 24 weeks. This further supports Hua Medicine’s strategy to establish dorzagliatin as a cornerstone therapy through combination with existing therapies, metformin, DPP-4 inhibitors, SGLT-2 inhibitors, GLP-1 receptor agonists, and  insulin etc. The Company aims provide more T2D patients with personalized treatment and address the underlying cause of diabetes.

The relatively low diagnosis and treatment rates of T2D in China, and the huge population of non-diagnosed and drug-naïve T2D patients and renal impaired patients, provide a large market opportunity for dorzagliatin. Current diabetes therapies still cannot effectively restore the body’s ability to control blood glucose level autonomously, nor modify or stop the progression of diabetes into more advanced stages of the disease, leading diabetes-associated complications. By contrast, clinical data to date further supports that, dorzagliatin has the potential to restore glucose homeostasis, has the potential use in the glucose management among T2D patients with diabetic kidney disease. In preparation for dorzagliatin’s NDA with NMPA and for the launch in China, the Company has fully validated the cGMP commercial manufacturing processes for API and drug product.

"Hua Medicine has achieved fruitful research and development progress in the first half of 2020. As part of our strategy to establish dorzagliatin as a cornerstone therapy for the treatment of T2D globally, these positive results reliably allow us to advance our mission. We will continue to investigate the combination of dorzagliatin with various approved anti-diabetic medicines and explore its clinical application across a full range of T2D patients and those with metabolic syndrome or other diabetes complications, and eventually realize T2D patients’ personal needs globally," said Dr. Li Chen, Founder and Chief Executive Officer of Hua Medicine.

Clinical Trial Developments Significantly Enhanced Dorzagliatin’s Commercial Value

Future Pipeline Outlook

About Dorzagliatin
Dorzagliatin is an investigational first-in-class, dual-acting glucokinase activator, designed to control the progressive, degenerative nature of diabetes by restoring glucose homeostasis in patients with Type 2 diabetes. By addressing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired glucose homeostasis state of patients with Type 2 diabetes and serve as a first-line standard-of-care therapy for the treatment of the disease, or as a cornerstone therapy when taken in combination with currently approved anti-diabetes drugs.

About Hua Medicine
Hua Medicine is a leading, clinical-stage innovative drug development company in China focused on developing novel therapies for the treatment of diabetes. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine advanced a first-in-class oral drug for the treatment of T2DM into NDA-enabling stage and is currently evaluating the therapy in adults with diabetes in two Phase III trials in China and various earlier stage clinical trials in China and the United States. Dorzagliatin has achieved its primary endpoint in both of its Phase III monotherapy and combination trials in China over the 24-week trial period, and completed its 52-week Phase III monotherapy trial. The Company has initiated product life-cycle management studies of this novel diabetes therapy and advanced its use in personalized diabetes care. Hua Medicine is working closely with disease experts and regulatory agencies in China and across the world to advance diabetes care solutions for patients worldwide.

Please register for the interim results presentation at：
https://icaasia.zoom.us/webinar/register/ WN_dhEzirDmQimhjH_A2TfhsQ

For more information
Hua Medicine
Website：www.huamedicine.com
Investors
Website：ir@huamedicine.com
Media
Website：pr@huamedicine.com

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