Today, Huanling Pharmaceutical announced that after the review and on-site verification of the Drug Marketing Authorization Holder (MAH) system, the company has obtained the "Drug Production License" issued by the Shanghai Drug Administration for the development of the world's first new drug dorzagliatin.
　　Dozaglietine is the world's first dual-acting glucokinase activator under development designed to control the progression of diabetic progressive degenerative disease by restoring blood glucose homeostasis in patients with type 2 diabetes. By repairing defects in glucose sensor function of glucokinase, dorzagliatin has the potential to restore impaired glucose homeostasis in patients with type 2 diabetes and could be used as a first-line treatment standard for the disease or as an underlying treatment in combination with currently approved anti-diabetic drugs.
　　It is reported that since the beginning of this year, the company has successfully completed two key milestones in the Phase III clinical trial registration of new drugs, including the Phase III clinical trial SEED (HMM0301) of Dozaglietine monotherapy in patients with untreated type 2 diabetes. And the metformin combination clinical trial DAWN (HMM0302) in patients with type 2 diabetes who had failed metformin adequate therapy. Clinical study data show that dozaglietine has shown significant stable efficacy and safety during the corresponding treatment cycle, and has the effect of improving the function of islet beta cells, promoting insulin secretion in early phase and reducing insulin resistance, which is expected to fundamentally treat diabetes.
　　Dozaglietine has registered a total of 11 clinical trials in China, of which 2 projects have completed phase 3 clinical trials before, and according to its corporate announcement, it is conducting a number of early clinical trials in the United States at the same time to treat adult type 2 diabetes.
　　In addition, many zaglietine drug registration acceptance number 8, a number of acceptance numbers have been included in the special review, and have been included in the list of major special varieties.
　　In addition, on August 17, Hua Ling Pharmaceutical and Bayer announced the establishment of strategic cooperation and reached a commercial cooperation agreement on Dozaglietine in China. Huanling will be responsible for the clinical development, production and supply, first-tier distribution, registration and pharmacovigilance of the product; As the exclusive promoter of Dozaglia Ettin in China, Bayer is responsible for its marketing, promotion and medical education activities in China, so that Huanling Pharmaceutical will receive 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 Manufacturing License" will further accelerate Hualing Pharmaceutical's New Drug marketing application (NDA) process, prepare for the commercial production and supply of drugs after the market, and lay a solid foundation for the gradual improvement of future production capacity.
　　According to public data, among adults aged 20-79 in the world, there are 463 million people with type 2 diabetes (T2DM), and the number of diabetes patients in China has increased to 140 million. With the current incidence trend, the global adult T2DM patients will exceed 700 million in 2045, with a growth rate of 51%. At present, the incidence of diabetes in China is 12.8%, which is one in eight Chinese people. Pre-diabetes accounts for 35.2 percent, or about one in three people. In recent years, although a number of hypoglycemic drugs with different mechanisms of action have been listed, the overall glycemic compliance rate of patients is still less than 50%. Now, Dozaglietine of Huatling Pharmaceutical has been approved for production, and dozaglietine can restore the physiological glucose-regulating function of patients by repairing damaged glucokinase (GK) in the body. Glucokinase (GK) is a blood glucose sensor in the human body, which plays a central role in maintaining blood glucose homeostasis. It may have the potential to fundamentally solve the blood glucose instability in diabetic patients.