HTD1801: Type 2 Diabetes (T2DM)

Diabetes is a common chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. This condition results in too much sugar circulating in the bloodstream.  Type 2 diabetes mellitus (T2DM), accounts for more than 90% of diabetes and is largely the result of excess body weight and physical inactivity.  Hyperglycemia (high blood glucose), over time, leads to serious long-term complications, especially the nerves and blood vessels.

Nonalcoholic fatty liver disease (NAFLD) is part of the metabolic syndrome characterized by diabetes, obesity, and elevated blood lipids such as cholesterol and triglycerides (dyslipidemia) and is a common chronic liver condition worldwide.  The main characteristic of NAFLD is too much fat stored in liver cells.  If the disease progresses, NAFLD can lead to cirrhosis and end stage liver complications.  Having high levels of fat in your liver is also associated with an increased risk of problems such as diabetes and cardiovascular disease.  There is a strong bidirectional relationship between T2DM and NAFLD. The two indications are mutual common comorbid conditions with shared risk to targeted organs; About 49-62% of T2DM patients suffer from comorbid NAFLD1.  When T2DM co-exists with NAFLD, it significantly increases the rate of disease progression and risk of poor prognosis for patients: patients with comorbid T2DM and NAFLD tend to have poorer control of glycemia, more severe liver disease, and a higher risk of cardiovascular disease.  Therefore, the treatment goal for these patients should focus on a broader spectrum of beneficial effects, including: stricter glycemic control, delay the progression of liver disease and control of CV risk factors, such as obesity and dyslipidemia.

How does HTD1801 treat type 2 diabetes?

HTD1801 is designed for multiple targets and pathways, providing a balanced multifunctional approach to the treatment of T2DM and its comorbidities including NAFLD, obesity and dyslipidemia. Results from clinical studies have demonstrated that HTD1801 is safe and well-tolerated, and has comprehensive beneficial effects including:

Improvement of glycemic control including reduction in HbA1c

Reduction of lipids including total cholesterol, LDL-c and triglycerides

Reduction of body weight

Reduction of liver fat

Improvement of liver health including lowering of markers of injury and fibrosis biomarkers

Market Overview

According tothe consulting firm CIC:

● The prevalence of diabetes in Chinese adults is as high as 11.2% , 90% of which are Type 2 diabetes (T2DM). There were approximately 123.2 million T2DM patients in China in 2022. Worldwide prevalence of NAFLD (Nonalcoholic Fatty Liver Disease) among people with T2DM is 55.5%.

● There remains a lack of effective oral therapies that target not only hyperglycemia but broader cardiometabolic effects to satisfy the needs of patients with T2DM+NAFLD comorbidities.

1. Management of Chinese adults with type 2 diabetes and nonalcoholic fatty liver disease: an expert consensus



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