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New drug developed by a Shanghai company can put diabetes into remission for patients in China. Why isn’t it available anywhere else yet?

by Muhsina
in Health
0

Putting mainland China ahead of the rest of the world in the treatment of type 2 diabetes (T2D), Hua Medicine’s novel drug dorzagliatin is available at a subsidised price through more than 200,000 hospitals across the country.

The reason why this drug is little known in the West but only available to Chinese patients is that it was approved there in September 2022 and has been marketed since as HuaTangNing. After the approval, Hua Medicine’s partner Bayer launched distribution through select hospitals and online channels but the inclusion of dorzagliatin in the country’s National Reimbursement Drug List (NRDL) means that it will now be widely available.

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And sometime in early 2024, an Investigational New Drug (IND) application will be filed in the United States, to expand access to global markets.

Global first-in-class

Dorzagliatin is a global first-in-class glucokinase allosteric activator that treats diabetes by activating glucokinase, which is the body’s glucose sensor. By activating it, the body can better balance its levels of blood sugar, a state known as glucose homeostasis.

This is a more efficient and long-lasting approach to treating diabetes than, for example, injecting insulin to help the body process sugar.

Dorzagliatin restores the ability to autonomously self-regulate glucose levels (glycemic control) and maintain a healthy glucose balance (glucose homeostasis) in select T2D patients. This means that, unlike other diabetes drugs in the market, dorzagliatin is a ‘smart drug’ that can treat the root causes of diabetes.

The novel approach has been the focus of a lot of research and many scientific papers that build on years of research and large clinical trials in China.

One paper titled “Diabetes remission in drug-naïve patients with type 2 diabetes after dorzagliatin treatment: A prospective cohort study” and published in the journal Diabetes, Obesity and Metabolism maps out the drug’s ability to help patients achieve blood glucose balance and lead to drug-free diabetes remission for at least a year without the need of other drugs.

Financial position

Hua Medicine has partnered with German drug giant Bayer for the distribution of dorzagliatin in China. Hua recently received a US$113 million milestone payment from sales of the drug, which gives the Hong Kong-listed company a strong cash position as part of the agreement with the European company.

The inclusion of dorzagliatin into the NRDL should lead to drastically expanded sales of this innovative drug in China while the efforts to expand sales to the U.S. should begin the process of facilitating access to this important diabetes drug to people around the world.

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