GLP-1/GIP Dual-Target Receptor Agonist (THDBH120 for Injection) Clinical Trial Approval for Weight Loss Indication Declaration

April 26, 2024  Source: drugdu 34

"/Tonghua Dongbao Pharmaceutical Co. (hereinafter referred to as the "Company", "Tonghua Dongbao"), a wholly-owned subsidiary of Tonghua Dongbao Zixing (Hangzhou) Biomedicine Co., Ltd. has recently obtained the clinical trial approval for THDBH120 for weight loss indication from the Center for Drug Evaluation (CDE) of the State Drug Administration. THDBH120 for injection for the indication of weight loss drug clinical trial approval notice.

The approval of the clinical application for THDBH120 for weight loss indication for injection signifies that the company's GLP-1 pipeline in the field of overweight and obesity treatment has also stepped into the phase of clinical trials, which is of milestone significance. In the future, the Company will accelerate the research and development progress of THDBH120 for injection in diabetes indication and weight loss indication, and further explore and tap the potential of other indications to maximize the value of the product.

THDBH120 for injection has a huge market potential in the future, and the sales scale of its analogous drug Tirzepatide, the world's first dual-targeted GLP-1/GIP receptor agonist, has been growing rapidly after it was launched.Tirzepatide diabetes indications product (trade name: Mounjaro) Injection was successively approved for marketing by the FDA and EMA in 2022, with global sales of approximately $5,163 million in 2023 (2022: approximately $483 million). Its product for weight loss indication (trade name: Zepbound) was approved for marketing by the FDA in November 2023, and sales have already reached approximately $176 million in less than 2 months after being approved for marketing.

About THDBH120 for Injection
(GLP-1/GIP dual target receptor agonist)
Multiple agonism and long-acting synergism are the dominant R&D trends for peptide-based weight loss hypoglycemic agents. THDBH120 for injection is a dual-target agonist of glucagon-like peptide-1 (GLP-1) receptor and glucagon-like insulinotropic polypeptide (GIP) receptor, which combines the effects of GLP-1 and GIP, two types of insulinotropic hormones, into one single peptide molecule, and further improves the metabolic stability through the molecular design, which synergistically promotes the functions of glycemic control, weight loss, and regulation of lipid metabolism. It also further improves metabolic stability through molecular design to synergistically promote glycemic control, weight loss and lipid metabolism regulation, which meets the clinical needs of diabetic patients who are poorly treated with single molecular targets or compound preparations, and is expected to become a more long-lasting treatment for diabetes and obesity. In addition, the Company's THDBH120 diabetes indication for injection has entered the clinical Phase Ia study stage.

About Overweight and Obesity
In recent years, the number of deaths caused by chronic non-communicable diseases ("chronic diseases"), such as cardiovascular diseases, diabetes, and some cancers, accounts for nearly 90% of the total number of deaths of China's residents, and has become a major public health problem in China and even globally, and overweight and obesity are the major risk factors for chronic diseases. According to the Report on Nutrition and Chronic Disease Status of Chinese Residents (2020), the combined overweight/obesity rate of China's adult residents is more than 50% (overweight rate of 34.3%, obesity rate of 16.4%). At present, lifestyle intervention is the basic treatment for overweight and obese people, but there are still some patients who need to achieve weight loss goals through drug therapy, and there is a vast clinical demand for drugs with good weight loss effect and high safety.

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