Pivotal Phase III Trial Achieved Clinical Efficacy Endpoint at 24 Weeks
Dorzagliatin-Driven Portfolio Expands
SHANGHAI, China, March 16, 2020 (GLOBE NEWSWIRE) -- Hua Medicine (the “Company”, Stock Code on The Stock Exchange of Hong Kong Limited: 2552.HK), a global innovative drug research and development company focused on novel therapies for the treatment of diabetes, today announces the audited consolidated results of the Company and its subsidiaries for the year ended December 31, 2019. For the year ended December 31, 2019, the Company incurred approximately RMB468.5 million in total expenses, of which approximately RMB 321.9 million was research and development expenses. As of December 31, 2019, the Company’s cash position was approximately RMB 1,105.6 million.
Hua Medicine will continue to execute on its strategic goal of becoming a global diabetes care and management company, and is devoted to the development, registration and launch of dorzagliatin (HMS5552) in China and around the world. Hua Medicine achieved many milestones in 2019. The core scientific concept for dorzagliatin as a first-in-class drug was further validated, and the dorzagliatin-driven portfolio of diabetes therapies reflected in our pipeline continued to expand and advance. The Phase III monotherapy trial (HMM0301) for dorzagliatin (HMS5552) achieved its primary efficacy endpoint. The study results indicated that dorzagliatin was well tolerated during the 24-week study period, exhibited very low incidences of hypoglycemia and had a good safety profile. Meanwhile, two Phase I clinical trials with dorzagliatin (HMM0110 and HMM0111) also demonstrated satisfactory results. The results of HMM0110 demonstrated that dorzagliatin has the potential to be used in Type 2 diabetes (T2D) patients with moderate, severe and end stage chronic kidney disease (i.e., stages 3-5 of CKD); several top-selling oral anti-diabetes drugs must undergo dose adjustment (e.g., metformin and sitagliptin) when used for such T2D patients, or simply can’t be used at all for such patients (e.g., select SGLT-2 inhibitors). The results of HMM0111 confirmed the clinical advantages and potential synergies of dorzagliatin in combination with sitagliptin (a DPP-4 inhibitor), one of the best-selling oral anti-diabetic drugs globally.
The diagnosis rate of Type 2 diabetes is relatively low in China. Accordingly, there is a huge population of non-diagnosed and drug-naïve T2D patients in China, which provides a big market opportunity for dorzagliatin. Current diabetes therapies still cannot effectively restore the healthy 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 to the development of diabetes-associated complications. In contrast, the results of pre-clinical and clinical studies (both completed and those currently under development) demonstrate that dorzagliatin has the potential to treat the underlying cause of Type 2 diabetes by fixing the impaired glucose sensor in all T2D patients and thereby restoring glucose homeostasis. Research data to date suggests that, as a cornerstone therapy, dorzagliatin possesses the potential of controlling the development of diabetes and preventing or delaying the occurrence of complications, either via monotherapy or through combination with currently available diabetes therapies.
“We will carry on implementing our developmental strategy, which consists of expanding in three dimensions: new products, global markets and new disease indications. By deploying dorzagliatin as a cornerstone therapy, we will establish an innovative, sharing and win-win scientific platform that focuses on the remodeling of glucose homeostasis, and eventually realize the personalized medicine of diabetes globally,” said Dr. Li Chen, Founder and Chief Executive Officer of Hua Medicine.
Clinical trial Highlights
Operational highlights
Financial Highlights
Future Pipeline Outlook
About Dorzagliatin
Dorzagliatin is a first-in-class, dual-acting glucokinase activator, designed to control the progressive degenerative nature of diabetes by restoring glucose homeostasis in people 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 people 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 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 advanced a first-in-class oral drug for the treatment of type 2 diabetes 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 first primary endpoint in a 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.