Today, Hua Medicine announced that after the review of the Marketing Authorization Holder (MAH) system and on-site inspection, the company has obtained the "Drug Manufacturing License" for the globally first-in-class innovative drug dorzagliatin issued by the Shanghai Municipal Drug Administration.

　　Dorzagliatin is a globally first-in-class dual-acting glucokinase activator under development, aimed at controlling the progressive degenerative development of diabetes by restoring glucose homeostasis in patients with type 2 diabetes. By repairing the defect in the glucose sensor function of glucokinase, dorzagliatin has the potential to restore impaired glucose homeostasis in type 2 diabetes patients and can serve as a first-line treatment standard for the disease or as a foundational therapy in combination with currently approved antidiabetic drugs.

　　It is reported that since the beginning of this year, Hua Medicine has successfully completed key milestones in two Phase III new drug registration clinical trials, including the Phase III monotherapy trial SEED (HMM0301) of dorzagliatin in drug-naive type 2 diabetes patients, and the metformin combination trial DAWN (HMM0302) in type 2 diabetes patients with inadequate response to full-dose metformin. Clinical data indicate that during the respective treatment periods, dorzagliatin demonstrated significant stable efficacy and safety, with effects on improving islet β-cell function, promoting early-phase insulin secretion, and reducing insulin resistance, showing promise for fundamentally treating diabetes.

　　According to Yaozhi data, dorzagliatin has registered 11 clinical trials domestically, of which 2 have completed Phase III trials. Additionally, according to company announcements, multiple early-stage clinical trials are being conducted simultaneously in the United States for the treatment of adult type 2 diabetes.

　　Furthermore, there are 8 drug registration acceptance numbers for dorzagliatin, several of which have been included in special review processes and listed as major special project varieties.

　　Moreover, on August 17, Hua Medicine and Bayer announced a strategic cooperation and reached a commercial cooperation agreement for dorzagliatin in China. Hua Medicine will be responsible for clinical development, production supply, primary commercial distribution, registration, and pharmacovigilance. Bayer, as the exclusive promoter of dorzagliatin in China, will handle marketing, promotion, and medical education activities in China. Hua Medicine received an upfront payment of 300 million RMB and will also receive milestone payments up to 4.18 billion RMB. The approval of the "Drug Manufacturing License" will further accelerate Hua Medicine's new drug application (NDA) process, prepare for commercial production and supply after launch, and lay a solid foundation for future capacity expansion.

　　Public data shows that among adults aged 20-79 worldwide, there are already 463 million patients with type 2 diabetes (T2DM). The number of diabetes patients in China has grown to 140 million. With the current incidence trend, the global adult T2DM population will exceed 700 million by 2045, a 51% increase. Currently, the diabetes prevalence rate in China is 12.8%, meaning 1 in every 8 Chinese people has diabetes; the prediabetes population accounts for 35.2%, approximately 1 in every 3 people is in a prediabetic state. Although multiple antidiabetic drugs with different mechanisms have been launched in recent years, the overall blood glucose control rate among patients remains below 50%. Now that Hua Medicine's dorzagliatin has been approved for production, it restores patients' physiological glucose regulation function by repairing the damaged glucokinase (GK) in their bodies. Glucokinase (GK) is the body's glucose sensor and plays a central role in maintaining glucose homeostasis. It may fundamentally solve the problem of unstable blood glucose in diabetes patients.