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August 17, 2023, China, Shanghai

Shanghai, 17 August 2023 – Sending Type 2 diabetes into remission is now a possibility thanks to Hua Medicine's HuaTangNing¹(華堂寧^?) (dorzagliatin), as reported in a new published paper based on data from a 52-week study.

Although much excitement in the diabetes field currently revolves around the weight-loss function of the various new drugs that fall under the GLP-1 agonists class, a recent paper published in the influential journal Diabetes, Obesity and Metabolism reports data from a 52-week study to show how patients with Type 2 diabetes on the novel glucokinase (GK) class of drug can achieve remission and maintain it after a year without the need to use other drugs subsequently. The paper titled "Diabetes remission in drug-na?ve patients with type 2 diabetes after dorzagliatin treatment: A prospective cohort study² outlines the ability of dorzagliatin³ to help patients achieve blood glucose balance, leading to drug-free diabetes remission.

Given the rising incidence of diabetes in China and around the world, dorzagliatin is a new tool in the treatment of diabetes by targeting one of the root causes of diabetes. The drug is currently approved and marketed in mainland China.

The glucokinase enzyme serves as the body's natural glucose "sensor" to monitor blood sugar levels and stimulate the body to release various hormones, including insulin, glucagon, and GLP-1, to autonomously maintain a healthy glucose level 24 hours a day.  This ability to autonomously self-regulate and maintain a healthy glucose balance is known as glucose homeostasis.

Dorzagliatin aims to restore any deficiencies in the glucokinase function of Type 2 diabetes patients, tackling the root cause of Type 2 diabetes. In so doing, it is recognized as a "smart" drug that improves the body's sensitivity to changes in glucose levels and only works when needed (i.e., when glucose levels are changing). This ability of dorzagliatin is outlined in a July 2023 paper published in Life Metabolism⁴.

This ability sets dorzagliatin apart from some other approved Type 2 diabetes drugs that simply focus on reducing blood sugar levels in the moment, and therefore have no ability to achieve diabetes remission because their mechanisms of action do not provide a lasting effect that can restore the body’s natural ability to autonomously maintain glucose homeostasis. A June 2023 paper in Diabetes, the influential journal of the American Diabetes Association, compared the effects of dorzagliatin with other glucokinase activators⁵.

Participants in studies conducted by Hua Medicine experienced improvements in their ability to detect glucose, produce insulin, and experienced a reduction in insulin resistance. These beneficial effects are long-lasting for many Type 2 diabetes sufferers that used dorzagliatin and led to diabetes remission without the need to use medication.

In addition, patients that used dorzagliatin were found to have achieved a time in range (TIR) of 80% or higher after 46 weeks of treatment and increased the possibility of remission, which could be maintained over a 52-week period. TIR refers to the period that the levels of glucose in the body remain within an acceptable range, a clinical indicator of glucose homeostasis.

Hua Medicine (HKEx:2552) has continued to research the long-term impact of dorzagliatin on diabetes, reversing decades of reliance on drugs from earlier generations that simply and unilaterally reduce blood sugar levels. Until now, there have been no drugs available with the ability to smartly address the root cause of Type 2 diabetes or the potential to induce clinical remission. Dorzagliatin is the first. In a clinical study demonstrating this point, a September 2019 paper published in Diabetes Care found that three different active treatments commonly used to treat Type 2 diabetes generated no sustained improvements in beta cell function⁶.

"All the existing drugs treat the symptoms of Type 2 diabetes, such as hyperglycemia, and not the root causes of beta cell function failure. Hua Medicine's years of research and product development changed all that with the approval of dorzagliatin in mainland China," said Hua Medicine's Founder and CEO, Dr. Chen Li, who co-authored the most recent study. "The new paper based on data from our two comprehensive studies SEED and DREAM expands on the many benefits that dorzagliatin can bring to patients."

The National Medical Products Administration (NMPA) approved the drug for sale and use in mainland China at the end of September 2022.

The benefits dorzagliatin generated for patients has attracted considerable attention among the biopharma community. Hua Medicine works with multinational biopharmaceutical firm, Bayer, to commercialize the drug in mainland China.

¹ http://yi92.cn/En/HuaTangNing
² https://dom-pubs.onlinelibrary.wiley.com/doi/epdf/10.1111/dom.15179
³ Dorzagliatin is a novel allosteric glucokinase activator (GKA) – the first and only-in-class GKA in the world.
⁴ https://academic.oup.com/lifemeta/advance-article/doi/10.1093/lifemeta/load031/7223737
⁵ https://diabetesjournals.org/diabetes/article/72/Supplement_1/293-LB/150645/293-LB-Dorzagliatin-a-Glucokinase-Activator
⁶ https://diabetesjournals.org/care/article/42/9/1742/36298/Lack-of-Durable-Improvements-in-Cell-Function

More details of the latest study can be found  here.

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About Hua Medicine
Hua Medicine develops new and innovative drugs. We team up with top talent from around the world to develop breakthrough technologies and products that advance diabetes care. Hua Medicine (HKEx:2552) is based in Shanghai and listed on The Stock Exchange of Hong Kong.
Our cornerstone product, HuaTangNing (華堂寧^?) (dorzagliatin tablets), could help millions of diabetic patients around the world.
HuaTangNing (華堂寧^?) targets the glucose sensor glucokinase, restoring glucose sensitivity and stabilizing blood glucose imbalances.  Approved in China, HuaTangNing (華堂寧^?) can be used alone or as part of a combination to help people suffering from chronic kidney disease and Type 2 diabetes. Data from clinical studies showed this innovative drug has the potential to bring about clinical remission of diabetes.
China's National Medical Products Administration (NMPA) approved the commercialization of HuaTangNing (華堂寧^?) in September 2022.

Note: The article is intended to convey information from the peer-reviewed medical literature. For the accuracy and completeness of the content, references to information related to products launched in China, especially logos or requirements, should follow the relevant documents approved by the Chinese regulatory authorities.
The above information should not be interpreted as a recommendation or promotion of any drug or treatment regimen, nor should it substitute for the medical advice of any health care professional, who must be consulted for matters related to medical treatment.
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