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Hua Medicine Announces 2019 Hong Kong Stock Exchange Annual Results: 2,552

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A pivotal phase III trial has reached the criterion of clinical efficacy at 24 weeks
Dorzagliatin-focused portfolio expands

SHANGHAI, China, March 16, 2020 (GLOBE NEWSWIRE) – Hua Medicine (the company, Hong Kong Stock Exchange Limited stock code: 2552.HK), an innovative global drug research and development company focused on new therapies for the treatment of diabetes, announces today 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 has committed about RMB 468.5 million total expenditure, of which about RMB 321.9 million were research and development costs. As of December 31, 2019, the company's cash position was around RMB 1,105.6 million.

Hua Medicine will continue to achieve its strategic goal of becoming a global diabetes care and management company and is dedicated to the development, registration and launch of dorzagliatine (HMS5552) in China and around the world. Hua Medicine crossed many milestones in 2019. The basic scientific concept of dorzagliatine as a first-class drug has been validated and the portfolio of dorzagliatine-focused diabetes therapies reflected in our pipeline has continued to grow. ; expand and progress. The monotherapy phase III trial (HMM0301) for dorzagliatine (HMS5552) achieved its primary efficacy endpoint. Study results indicated that dorzagliatine was well tolerated during the 24 week study period, had very low incidences of hypoglycemia and had a good safety profile . In parallel, two phase I clinical trials with dorzagliatine (HMM0110 and HMM0111) have also shown satisfactory results. The results of HMM0110 demonstrated that dorzagliatine can be used in patients with type 2 diabetes (T2D) with moderate, severe and end-stage chronic kidney disease (i.e. stages 3 at 5 of IRC); many of the best-selling oral anti-diabetic drugs must undergo dose adjustment (eg, metformin and sitagliptin) when used for such T2D patients, or simply cannot be used at all for such patients (for example, some SGLT-2 inhibitors). The results of HMM0111 confirmed the clinical benefits and potential synergies of dorzagliatine in combination with sitagliptin (a DPP-4 inhibitor), one of the world's best-selling oral anti-diabetic drugs.

The diagnosis rate for type 2 diabetes is relatively low in China. As a result, there is a huge population of undiagnosed T2D patients and nave drugs in China, which offers a great market opportunity for dorzagliatine. Current diabetes therapies still cannot effectively restore the healthy body's ability to independently control blood glucose levels, or alter or stop the progression of diabetes to more advanced stages of the disease, leading to the development of complications. associated with diabetes. In contrast, the results of preclinical and clinical studies (completed and under development) demonstrate that dorzagliatine has the potential to treat the underlying cause of type 2 diabetes by repairing the impaired glucose sensor in all T2D patients and thereby restoring glucose homeostasis. Research evidence to date suggests that, as a basic therapy, dorzagliatine has the potential to control the development of diabetes and prevent or delay the onset of complications, either as monotherapy or in combination with currently available diabetes therapies.

We will continue to implement our development strategy, which consists of developing in three dimensions: new products, global markets and new indications of diseases. By deploying dorzagliatine as a base therapy, we will establish an innovative, shared and win-win scientific platform that focuses on reshaping glucose homeostasis, and eventually achieving personalized diabetes medicine around the world, said Dr. Li Chen, founder and CEO Hua Medical Officer.

Highlights of clinical trials

  • Primary efficacy endpoint achieved over 24 weeks in a double-blind, placebo-controlled phase III trial in patients with type 2 diabetes (T2D) in China (HMM0301), with very low incidents of hypoglycemia and good safety profiles. As of March 2, 2020, the patient's last 52-week visit (plus one week of follow-up) for HMM0301 had ended.
  • Registration completed in a phase III registration trial of the metformin add-on (HMM0302). On February 16, 2020, the 24-week patient visit for HMM0302 was completed
  • HMM0110 completed, which demonstrated the desirable pharmacokinetic profile in patients with end-stage chronic renal failure, indicating the potential use of dorzagliatin in T2D patients with moderate, severe chronic renal failure and terminal (i.e. stages 3 to 5 of CRI).
  • HMM0111 completed, which studied the pharmacokinetics (PK) and pharmacodynamics (PD) parameters of dorzagliatine alone or in combination with sitagliptin (a DPP-4 inhibitor) in T2D patients, and demonstrated the potential for combination and synergy between the two drugs
  • Obtaining a formulation patent for dorzagliatine in China
  • Filing of six patent applications covering the DPI of a fixed-dose combination of dorzagliatine with six classes of oral anti-diabetic drugs
  • Fully validated cGMP (Current Good Manufacturing Practice) commercial manufacturing processes for the active pharmaceutical ingredient (API) and drug product to support the launch of dorzagliatine in China

Operational highlights

  • Started an official collaboration on the central role of glucokinase in the control of glucose homeostasis with Dr Franz Matschinsky, professor of biochemistry and biophysics, Institute of Diabetes, Obesity and Metabolism Perelman School of Medicine, Philadelphia and recipient of the 1995 Banting Medal for Science Achievement and Rolf Luft Prize 2020
  • Presentation of AI-based machine learning results at the 79th Scientific Sessions of the American Diabetes Associations, providing an unbiased methodology for subclassing T2D patients
  • Announcement of the inauguration of the global operations headquarters and the research and development center in Shanghai ZhangJiang Science City
  • Former U.S. FDA officer Dr Fuxing Tang joined Hua Medicine as chief technology officer, vice president of R&D on formulation and product development

Financial highlights

  • Cash was around RMB 1,105.6 million as of December 31, 2019.
  • The pre-tax loss decreased by about 3,178.7 million RMB, or about 88.2%, to about 425.3 million RMB.

Future pipeline prospects

  • The company plans to announce the result of the 52-week phase III trial for the monotherapy trial (HMM0301) no later than the third quarter of 2020
  • The company plans to announce the 24-week phase III result for the combination with the metformin trial (HMM0302) no later than the third quarter of 2020, and the 52-week result for here the end of 2020.
  • The company plans to partner with Chinese or international pharmaceutical companies to make dorzagliatine and related products, as new therapies, available to patients in China and regions outside of China.
  • HMM0109 is a phase I trial that studies the pharmacokinetic profile of patients with hepatic impairment in China.
  • HMM0112 is a combination of dorzagliatine and empagliflozin (an SGLT-2 inhibitor) phase I in T2D patients in the United States. The company announced that the first patient was treated in April 2019 and is expected to complete and announce the results by the first half of 2020.
  • In order to further expand the indications for dorzagliatines for the treatment of T2D, the company is investigating the combination of dorzagliatine with various approved classes of oral anti-diabetic drugs and is expanding the dorzagliatine-focused portfolio to meet the personal needs of patients.

About Dorzagliatin
Dorzagliatine is a first-class double-acting glucokinase activator, designed to control the progressive degenerative nature of diabetes by restoring glucose homeostasis in people with type 2 diabetes. By correcting the defect in the function of Glucokinase glucose sensor, dorzagliatine has the potential to restore the altered glucose homeostasis of people with type 2 diabetes and serve as the standard first-line treatment for the treatment of disease. , or as a basic therapy when taken in combination with currently approved anti-diabetes drugs.

About Hua Medicine
Hua is a leading China-based clinical drug development company focused on the development of new therapies for the treatment of diabetes. Founded by an experienced group of entrepreneurs and international investment companies, Hua has developed a first-rate oral drug for the treatment of type 2 diabetes in an NDA-enabling stage and is currently evaluating therapy in adults with diabetes in two phase III trials in China and various early-stage clinical trials in China and the United States. Dorzagliatine achieved its first primary endpoint in a phase III monotherapy trial. The company has launched life cycle management studies for the products of this new diabetes therapy and has advanced its use in personalized diabetes care. Hua Medicine works closely with disease experts and regulatory bodies in China and around the world to advance diabetes care solutions for patients around the world.

For more information
Hua Medicine
Website: www.huamedicine.com
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Porda Havas International Finance Communication Group
Cathy Pan
Phone: (852) 3150 6777
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