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Hua Medicine Announces 2020 Interim Results
August 17, 2020 – Shanghai, China
| Pivotal Phase III Monotherapy Trial Successfully Completed | |
| Phase III Combination with Metformin Trial Achieved Primary Efficacy and Safety Endpoints at 24 Weeks |
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
| ● | Successfully completed the Phase III registration trial SEED/HMM0301, dorzagliatin’s monotherapy trial among drug-naïve T2D patients, which demonstrated sustained efficacy and safety and significant improvement of insulin resistance over the 52-week treatment period. | |
| ● | Achieved the primary efficacy and safety endpoints in the 24-week double-blinded placebo-controlled Phase III registration trial DAWN/HMM0302, demonstrating good glycemic control and significant improvement of islet function and insulin resistance. The trial was a dorzagliatin in combination with metformin trial conducted in metformin tolerant T2D patients in China. | |
| ● | Completed HMM0110, which demonstrated a desirable pharmacokinetic profile in patients with end-stage chronic kidney disease, indicating the potential use of dorzagliatin for glycemic control among T2D patients with renal impairment in mild, moderate, severe, and end-stage before dialysis. | |
| ● | Completed HMM0111, which successfully demonstrated the possibility of administering dorzagliatin in combination with sitagliptin, the global top-selling DPP-4 inhibitor, as well as the potential synergies from the combination. | |
| ● | Completed HMM0112, which successfully demonstrated the possibility of administering dorzagliatin in combination with empagliflozin, a top-selling SGLT-2 inhibitor, as well as the potential synergies from the combination. | |
| ● | Presented additional data from the SEED 24-week period study, demonstrating improvements in β-cell function in patients treated with dorzagliatin at the 2020 American Diabetes Association’s 80th Scientific Sessions. | |
Future Pipeline Outlook
| ● | The Company plans to announce the top-line 52-week Phase III trial results for the combination with metformin trial (DAWN/HMM0302) by year-end 2020. | |
| ● | The Company plans to file for NDA approval with the NMPA after the completion of both 52-week Phase III trials. | |
| ● | The Company plans to partner with either China-based or international pharmaceutical companies to make dorzagliatin available to patients, in both China and regions outside of China. | |
| ● | HMM0109 is an on-going Phase I trial studying the impact on pharmacokinetics for patients with hepatic impairment in China. | |
| ● | In order to continue the expansion of dorzagliatin’s indications for the treatment of T2D, the Company plans to initiate trials in combination with other available medicines to expand the Company’s dorzagliatin-driven portfolio. | |
| ● | As part of the strategy to establish dorzagliatin as a cornerstone therapy for the treatment of T2D globally, the Company would expect to collaborate with global experts in T2D to further understand the potential of dorzagliatin. | |
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：
http://icaasia.zoom.us/webinar/register/ WN_dhEzirDmQimhjH_A2TfhsQ
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