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Hua Medicine's SEED Researchers to Present Key Research Results on Diabetes Remission at the China BioMed Innovation and Investment Conference
23 September 2021 – Shanghai, China
Hua Medicine (the "Company", SEHK stock code: 2552.HK) today announced that at the 6th China BioMed Innovation and Investment Conference to be held on September 25-27, 2021 in Suzhou, China (the "CBIIC"), select researchers participating in the Hua Medicine Phase III SEED Study ("SEED Study", also known as HMM0301) will present results from a clinical study called DREAM, which will show the sustained efficacy and diabetes remission of dorzagliatin, a glucokinase activator and a first-in-class anti-diabetic investigational drug of Hua Medicine.
The main objective of the DREAM study is to evaluate the ability of Type 2 diabetes patients that participated in our SEED Study (i.e., treated with dorzagliatin for 28 or 52 weeks) to maintain glucose levels and improvement of islet beta cell function without any glucose-lowering medication after the completion of the SEED study. Professor Ma Jianhua, Director of the Department of Endocrinology, Nanjing First Hospital, Standing Member of the Chinese Diabetes Society, will share the results of the study as the researchers’ representative at the session of Clinical Trial Data Release session of the CBIIC on September 25, 2021.
A recent consensus report from the American Diabetes Association (ADA) defines sustained improvement to near normal levels after stopping medication as "remission" in patients with Type 2 diabetes. At present, the main attempts for diabetes remission are intensive insulin therapy in Chinese patients, gastrectomy intervention (i.e., bariatric surgery) in patients worldwide and strict weight loss in western countries. The consensus states that a patient may be considered to be in diabetes remission if, 3 months after stopping medication, his or her HbA1c level remains below 6.5% or, in some cases, fasting plasma glucose of less than 7.0 mmol/L as an equivalence criterion or an eA1C of less than 6.5% as calculated from ambulatory glucose monitoring data. The consensus has gained widespread attention in the field of diabetes clinical therapy and drug development.
The two Phase III registration clinical trials concluded earlier by Hua Medicine have shown that dorzagliatin has demonstrated long-term stable efficacy and good safety performance during clinical treatment, effectively improving the dysregulation of insulin secretion, beta-cell function and insulin resistance. The results of the DREAM Study are expected to spark further active discussions in the medical community about "diabetes remission" and are expected to lead to new options for the treatment of Type 2 diabetes in China.
CBIIC is a high-end communication platform between the pharmaceutical industry and the investment community initiated and established by China Pharmaceutical Innovation and Research Development Association in 2016. In recent years, it has become an important platform for presentation of pharmaceutical innovation results, publication of clinical data, and sharing of investment trends and experiences in the pharmaceutical industry, and is praised as the "most popular cooperation platform for pharmaceutical innovation and investment in Asian-Pacific region".
At the CBIIC, in addition to the DREAM study results, Dr. Chen Li, CEO, Founder and Chief Scientific Officer of Hua Medicine, will also report on Hua Medicine's development experience and future outlook at the session of Listed Company Roadshow.
Highlights of Hua Medicine at the CBIIC:
Topic: DREAM Study Result Release for the First Time, First-In-Class Antidiabetic Investigational Drug Dorzagliatin’s Lasting Effect in Diabetes Remission
Speaker: Dr. MA Jianhua, Director of Department of Endocrinology, Nanjing First Hospital, Standing Member of the Chinese Diabetes Society
Time: 14:25-14:50 on 25 September 2021
Session: Clinical Trial Data Release
Topic: Introduction of Future Pipeline - Hua Medicine
Speaker: Dr. Chen Li, Founder, CEO and Chief Scientific Officer of Hua Medicine
Time: 9:50-10:15 on 26 September 2021
Session: Listed Company Roadshow
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 insulin and GLP-1 secretion of patients with Type 2 diabetes and serve as a cornerstone therapy targeting the root cause of the disease. Two Phase III registration trials for dorzagliatin monotherapy and the combination of dorzagliatin and metformin have been completed in China, as well as studies on drug mechanism synergy with sitagliptin (DPP-4 inhibitor) and empagliflozin (SGLT-2 inhibitor). The Company has obtained the "Drug Manufacturing Permit" of dorzagliatin issued by the Shanghai Municipal Drug Administrative Bureau, and has submitted its NDA to the National Medical Products Administration, so as to realize the "First in Global, Start from China" mission objective for the benefit of diabetic patients worldwide.
About Hua Medicine
Hua Medicine is a leading, innovative biotechnology company in China focused on developing novel therapies for diseases with unmet medical needs. 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 stage and it has 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 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.
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