China-based innovative drug developer Hua Medicine (HKG: 2552), with operations in the US and Hong Kong, China, has announced the successful completion of the SENSITIZE study. The study, led by Professor Juliana Chan, an international endocrinology specialist at the Chinese University of Hong Kong, investigates the mechanism by which HuaTangNing (dorzagliatin tablets) improves β-cell glucose sensitivity.
SENSITIZE 2 Study Results: β-Cell Function and Insulin Secretion
The SENSITIZE 2 study results demonstrate that a single dose of dorzagliatin restores GK enzyme activity, significantly enhancing the second-phase insulin secretion and β-cell glucose sensitivity in individuals with impaired glucose tolerance (IGT) during a hyperglycemic clamp study. This finding is crucial for understanding the drug’s impact on glucose homeostasis in prediabetic conditions.
SENSITIZE 1 Study: Impact on GCK-MODY and Type 2 Diabetes Patients
Previously, the SENSITIZE 1 study revealed that dorzagliatin directly restores the activity of GK mutants, leading to significant improvements in the second-phase insulin secretion and β-cell glucose sensitivity in patients with glucokinase monogenic diabetes (GCK-MODY or MODY-2). It also significantly enhanced basal insulin secretion in newly diagnosed type 2 diabetes patients, highlighting the drug’s potential in managing type 2 diabetes mellitus.
Continued Research and Development
Hua Medicine will continue to investigate β-cell glucose sensitivity improvement and incretin effects in response to repeated doses of dorzagliatin in individuals with intermediate hyperglycemia (IH) and type 2 diabetes. The aim is to establish personalized intervention and treatment management plans for prediabetic and type 2 diabetes patients, furthering the drug’s clinical applications.
Dorzagliatin’s Market Approval and Partnership with Bayer
Dorzagliatin is designed to control the progressive degenerative characteristics of diabetes by restoring glucose homeostasis in patients with type 2 diabetes mellitus. The drug received its first market approval in October 2022 to treat metformin-intolerant type 2 diabetes, either as a monotherapy or in combination with metformin. In August 2020, German pharmaceutical giant Bayer AG (OTCMKTS: BAYRY) entered into a RMB 4.5 billion (USD 663.8 million) deal with Hua Medicine regarding dorzagliatin. Under the agreement, Hua, as the Marketing Authorization Holder (MAH), is responsible for clinical studies, regulatory filings, supply, and distribution, while Bayer handles marketing, promotion, and medical education activities. The agreement is set to terminate on January 1, 2025.-Fineline Info & Tech
