Hua Medicine says its new drug application (NDA) for HuaTangNing (dorzagliatin tablets) has been approved by the National Medical Products Administration (NMPA) in China.
HuaTangNing is a first-in-class glucokinase activator (GKA) developed by the company.
The approval is for two indications, both to improve blood glucose control for type 2 diabetes (T2D) patients, as monotherapy for drug-naive T2D patients, or in combination with metformin in metformin tolerated T2D patients to control blood glucose levels.
For patients with chronic kidney disease (CKD) and Type 2 diabetes (i.e., diabetes kidney disease), no dose adjustment is required. At the same time, clinical trials have shown HuaTangNing in combination with empagliflozin (SGLT-2 inhibitor) and sitagliptin (DPP-IV inhibitor) is expected to better improve blood glucose control and pancreatic islet functions in T2D patients than either empagliflozin or sitagliptin taken alone.
HuaTangNing is the first approved glucokinase activator (GKA) worldwide. The company said the commercialization of HuaTangNing is the first time globally in almost 10 years that a new mechanism of action to treat type 2 diabetes has been introduced.
The approval of HuaTangNing also represents the first approved GKA drug. Going forward, Hua Medicine will partner with Bayer to commercialize HuaTangNing in China, benefiting diabetic patients and their families.
Rising problem
Globally, the incidence of diabetes has been on the rise. According to the International Diabetes Federation (IDF), the number of adult diabetes patients worldwide reached 537 million in 2021, an increase of 74 million from 2019. Global health spending due to diabetes and its complications stood at $966 billion in 2021.
There were more than 140 million diabetic patients in China in 2021, of these, around 72.83 million have not been diagnosed or treated. In addition, fluctuating blood glucose levels lead to a series of diabetic complications such as cardiovascular and cerebrovascular, kidney, eye diseases, and diabetic feet, etc., which greatly affect the survival and life quality of diabetic patients, and exert a heavy pressure on their families.
Improving blood glucose regulation
Clinical studies have shown that HuaTangNing can restore the impaired glucokinase sensor function and improve the ability of T2D patients to regulate blood glucose autonomously.
As a new class of T2D treatment drug, HuaTangNing said it has received attention from the academic community worldwide. In 2018, the results of its phase II clinical trial were published in The Lancet Diabetes and Endocrinology, which was the first time the journal published the clinical research results of a T2D original innovative drug from China.
In May 2022, Nature Medicine simultaneously published two peer-reviewed papers on the results of the company’s two phase III clinical trials, describing the results of its monotherapy trial (the SEED study), and in combination with metformin trial (the DAWN study), respectively. It fully recognized HuaTangNing as a first-in-class diabetic drug with significant safety advantages and the characteristics of improving pancreatic islet functions in T2D patients. The unique advantages of HuaTangNing in T2D patients with nephropathy suggested by the clinical trials was also highlighted.
Key path to diabetes remission
Other clinical research also showed HuaTangNing safely creates clear synergies in combination therapy with DPP-4 inhibitors and SGLT-2 inhibitors in blood glucose control, suggesting its broader potential in T2D patients with different needs in glycemic control and at different stages of disease progression.
By potentially restoring early-phase insulin secretion and improving beta-cell function, HuaTangNing is expected to be a key path in diabetes remission. In the future, Hua Medicine will continue to explore HuaTangNing’s potential in the remission of T2D drug discontinuation and the combination therapies with the other nine existing types of diabetes drugs.
Working with Bayer
Xiaolan Zhou, executive vice president, pharmaceuticals Ddivision, Bayer AG and president of Bayer Pharmaceuticals China, said: “Bayer has been working on diabetes treatment and contributing to the development of diabetes prevention and treatment in China for years. HuaTangNing and Glucobay, the first oral hypoglycemic drug with impaired glucose tolerance (IGT), together with continuous glucose monitoring systems (CGMs), establish end-to-end course management from prevention to treatment for Chinese T2D patients.
“Real-time blood glucose monitoring helps achieve the goal of ‘steady blood glucose control’. At the same time, Bayer proactively explores digital solutions to help hundreds of millions of Chinese patients to achieve the vision of diabetes-free.”
Li Chen, the founder, CEO and chief scientific officer of Hua Medicine, said: “The NDA approval of HuaTangNing is a major milestone for Hua Medicine, as it also marks that the innovative drug industry in China has entered a new stage of new development. Diabetes chronic disease management is strategically important for China’s economy and people’s livelihood.
“We are proud of HuaTangNing and grateful to everyone for their hard work and wholehearted dedication. At the same time, Hua Medicine looks forward to in-depth integration and full vitality with Bayer in the commercialization of HuaTangNing, which will bring new hope of diabetes prevention, treatment and relief to up to one hundred million Chinese T2D patients, establish standards for diabetes prevention and treatment, and contribute to the national strategy of achieving Healthy China 2030.”
About HuaTangNing
HuaTangNing (dorzagliatin tablets) is a first-in-class glucokinase allosteric activator (GKA) with a new mechanism. It can be used alone or in combination with metformin hydrochloride (when using metformin hydrochloride alone is ineffective in controlling blood glucose), to improve blood glucose control for T2D adult patients with diet and exercise.
HuaTangNing targets restoration of the impaired glucose sensor glucokinase (GK) in the pancreas, intestine and liver, to achieve one target with multiple points and coordinated blood glucose control. It regulates glucose stimulated secretion of the glycemic controlling hormones insulin, GLP-1 and glucagon in diabetes patients, which leads to the improvement of early-phase insulin secretion and disposition index.
It has the potential to restore glucose homeostasis and diabetes remission. Results from two phase III registered trials of HuaTangNing monotherapy and combination therapy with metformin in metformin tolerated T2D patients showed HuaTangNing significantly improved glycemic control with effective reduction of post prandial glucose, low risk of hypoglycemia, good tolerance and safety.
HuaTangNing demonstrated a linear correlation between drug dose and plasma exposure, with high target organs distributed in pancreas, intestine and liver. It showed low renal excretion and similar pharmacokinetic profiles at end stage renal disease (ESRD) patients and healthy subjects, which suggest it can be readily used in those patients with renal insufficiency without dose adjustment.