Hua Medicine announced that the company 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 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. The Company plans to announce top-line 52-week Phase III trial result for the monotherapy trial (HMM0301) by no later than third quarter 2020. The Company plans to announce top-line 24-week Phase III result for the combination with metformin trial (HMM0302) by no later than third quarter 2020, and top-line 52-week result by year end 2020. The Company plans to partner with either China-based or international pharmaceutical companies to make dorzagliatin and related products, as brand new therapies, available to patients, in both China and regions outside of China. HMM0109 is a Phase I trial studying the pharmacokinetics profile for hepatic impaired patients in China. HMM0112 is a dorzagliatin combination with empagliflozin (a SGLT-2 inhibitor) Phase I trial in T2D patients in the United States. The Company announced the first patient was dosed in April 2019 and expect to complete and announce results by first half 2020. In order to continue expansion of dorzagliatin’s indications for the treatment of T2D, the Company is investigating the combination of dorzagliatin with various approved classes of oral anti-diabetic medicines and expand the dorzagliatin-driven portfolio to address patients’ personal needs. 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.