Researchers Present Key Research Findings on Dorzagliatin Diabetes Remission


SHANGHAI, Sep 26, 2021 – (ACN Newswire) – Hua Medicine (“Hua Medicine”; SEHK: 2552) today announced that at the 6th China BioMed Innovation and Investment Conference held from September 25-27 in Suzhou, China (the “CBIIC”), Professor Jianhua MA, Director of Endocrinology Department of Nanjing First Hospital, a permanent member of the Chinese Diabetes Society, as one of the main researchers, presented the results of a clinical study called DREAM, which showed that dorzagliatin, a glucokinase activator and a first-class investigational drug from Hua Medicine, can make progress in remission of diabetes.

The DREAM study is an observational, non-pharmacological and non-interventional clinical study initiated by certain researchers participating in the SEED study (also called HMM0301). The SEED study is a registered Phase III clinical study of dorzagliatin as monotherapy in drug-naïve type 2 diabetic patients for its long-term efficacy and safety. The main objective of the DREAM study is to assess the ability of patients with type 2 diabetes who participated in our SEED study and achieved glycemic control as defined by the researchers, to maintain normal glucose levels at almost normal (i.e., remission of type 2 diabetes), without any hypoglycemic drugs after completion of the SEED study for a minimum follow-up period of 52 weeks.

The DREAM study was conducted in a total of 69 patients at five clinical sites in China. The researchers comprehensively assessed the subjects and set their individual HbA1c control goals, and the research results showed that the subjects had a 52-week blood glucose remission rate of 65.2% (CI at 95%, 53.4%, 77.0%) [1] during the research period.

Prof Jianhua MA said, “Dorzagliatin, a new class of glucokinase activators, has been shown to be able to effectively improve early-phase insulin secretion, beta cell function and insulin resistance, leading to remission of type 2 diabetes. In the previous SEED study, dorzagliatin monotherapy also demonstrated stable long-term efficacy and a good safety profile. The DREAM study again showed positive results, where patients who achieved normal blood sugar levels after treatment with dorzagliatin were able to maintain blood sugar levels and beta cell function after stopping the drug. help us better understand the mechanism of diabetes remission and explore a more effective therapy for patients in clinical treatment.The DREAM study explores the possibility of oral dosing in diabetes remission and is of great importance in expanding treatment options for type 2 diabetes. “

At CBIIC, in addition to the results of the DREAM study, Dr Li CHEN, CEO, Founder and Scientific Director of Hua Medicine, also analyzed the drug landscape for type 2 diabetes and shared the development experience and the future prospects of Hua Medicine during the session. of the Roadshow of listed companies.

Dr Li CHEN said, “China has the largest number of diabetic patients in the world, with the number of type 2 diabetes patients exceeding 120 million. According to an epidemiological study published in the BMJ by Chinese researchers in 2020, the prevalence of diabetes and prediabetes in China was 12.8% and 35.2%, respectively, from 2015 to 2017, and the prevention and control of diabetes have become a strategic imperative to address this major public health problem.The American Diabetes Association’s recently released Diabetes Remission Consensus Report has sparked new thinking among clinicians and new drug developers. on how to prevent diabetes from becoming a permanent disease. The positive results of the DREAM study have bolstered our confidence in a cure for type 2 diabetes. Hua Medicine will continue to explore the broad prospects of dorzagliatin monotherapy and combination therapy, while continuing typing studies and research. using a combination of big da ta and artificial intelligence for the precise treatment of type 2 diabetes. Hua Medicine will also actively establish a glucokinase drug development platform based on the unmet clinical needs of the general public by China, and will strive to make further breakthroughs in neurodegenerative diseases, NASH and other diseases. “

To note:
[1] Calculated using the Kaplan-Meier methodology.

About Dorzagliatin

Dorzagliatin is an experimental, dual-acting glucokinase activator, first in its class, designed to control the progressive and degenerative nature of diabetes by restoring glucose homeostasis in patients with type 2 diabetes. Defective in the glucose sensor function of glucokinase, dorzagliatin has the potential to restore impaired insulin and GLP-1 secretion in patients with type 2 diabetes and to serve as baseline therapy targeting the root cause of the disease. Two phase III registration trials for dorzagliatin monotherapy and the combination dorzagliatin and metformin have been completed in China, as well as studies on the synergy of drug mechanisms with sitagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2 inhibitor). The Company has obtained the Dorzagliatin “Drug Manufacturing Permit” issued by the Shanghai Municipal Medicines Administrative Bureau and submitted its NDA to the National Medicines Administration, in order to achieve the goal of the “First in” mission. Global, Start from China ”for the benefit of diabetic patients worldwide.

About Hua medicine

Hua Medicine is a leading innovative biotechnology company in China focused on developing new therapies for diseases with unmet medical needs. Founded by an experienced group of entrepreneurs and international investment firms, Hua Medicine has promoted a first-class oral drug for the treatment of T2DM to NDA stage and successfully completed two phase III registration trials in China. for dorzagliatin. The Company has initiated product life cycle management studies of this novel diabetes therapy and has advanced its use in personalized diabetes care. Hua Medicine works closely with disease experts and regulatory agencies in China and around the world to advance diabetes care solutions for patients around the world. Hua Medicine is listed on the Hong Kong Stock Exchange Limited (stock code: 2552.HK)

About the DREAM study

The DREAM study is an observational study designed and conducted by certain principal investigators who participated in the SEED study to assess the effectiveness of dorzagliatin in treatment-naïve type 2 diabetic patients. The Company did not design or monitor the DREAM study, and does not own or control the data underlying the study, although the Company assisted the researchers in evaluating the data and related results.

For more information
Hua medicine
Website: www.huamedicine.com

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