Today, Hua Medicine announced that after the review of the Drug Marketing Authorization Holder (MAH) system and on-site verification, the company has obtained the world’s first innovative drug under research, dorzagliatin (dorzagliatin) issued by the Shanghai Drug Administration. "Drug Production License".
Dozagliptin is the world's first dual-acting glucokinase activator under research, which aims to control the development of progressive degenerative diseases of diabetes by restoring the blood glucose homeostasis of patients with type 2 diabetes. By repairing the defect of the glucose sensor function of glucokinase, dorzagliatin has the potential to restore the impaired blood glucose homeostasis in patients with type 2 diabetes. It can be used as the first-line standard of treatment for the disease or as a basic treatment in combination with currently approved anti-diabetic drugs .
It is reported that since the beginning of this year, Hua Medicine has successfully completed two key milestones in the registration and registration of two phase III new drugs, including the phase III clinical trial SEED of dozaglifledetin monotherapy in patients with unused type 2 diabetes. HMM0301), and the metformin combination clinical trial DAWN (HMM0302) in patients with type 2 diabetes who failed adequate metformin treatment. Clinical research data shows that in the corresponding treatment cycle, dozagliflozin exhibits significant and stable efficacy and safety, and has the effects of improving pancreatic β-cell function, promoting early insulin secretion and reducing insulin resistance, which is expected to be fundamental On the treatment of diabetes.
According to Yaozhi data, dozaglietin has registered a total of 11 clinical trials in China, of which 2 projects have completed phase three clinical trials before. In addition, according to its corporate announcement, it is conducting multiple early clinical trials in the United States simultaneously. Used to treat adult type 2 diabetes.
In addition, there have been 8 registration acceptance numbers for dozaglietin drugs, and several acceptance numbers have been included in the special review and included in the list of major special products.
In addition, on August 17, Hua Medicine and Bayer announced the establishment of a strategic cooperation, and reached a commercial cooperation agreement for Dozaglietin in China. Hualing will be responsible for the clinical development, production and supply, first-tier distributor distribution, registration and pharmacovigilance of the product; Bayer, as the exclusive salesman of dozaglietin in China, is responsible for its marketing, promotion and medical education in China For the event, Hua Medicine received a down payment of 300 million yuan and will also receive a milestone payment of up to 4.18 billion yuan. The approval of the "Drug Production License" will further accelerate the NDA process of Hua Medicine, prepare for the commercial production and supply of post-marketing drugs, and lay a solid foundation for the gradual increase in production capacity in the future.
Public data shows that among adults aged 20-79 in the world, there are already 463 million patients with type 2 diabetes (T2DM), and the number of diabetes patients in China has increased to 140 million. With the current trend of incidence, the global adult T2DM patients will be Over 700 million, with a growth rate of 51%. At present, the incidence of diabetes in China is 12.8%, with 1 in 8 Chinese people; the population with prediabetes accounts for 35.2%, and approximately 1 in 3 people is in prediabetes. In recent years, although many hypoglycemic drugs with different mechanisms of action have been put on the market, the patient’s overall blood glucose compliance rate is still less than 50%. Nowadays, China Medical’s dozaglifledin has been approved for production, and dozaglifled The damaged glucokinase (GK) in the patient's body enables the patient to restore its own physiological function of regulating glucose. Glucokinase (GK) is a blood glucose sensor in the human body and plays a central role in maintaining the steady state of human blood sugar. Or it will have the potential to fundamentally solve the instability of blood sugar in diabetic patients.