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Tonghua Dongbao announces NMPA acceptance of its clinical trial application for oral small-molecule GLP-1 receptor agonist (THDBH110 Capsules)
Date：2023-08-22
Author：東寶
Views：1
Recently, Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd. ("Dongbao Zixing"), a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. (the "Company" or "Tonghua Dongbao") received a notice of acceptance (No. CXHL2300887) from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the clinical trial of the oral small-molecule GLP-1 receptor agonist (THDBH110 Capsules).
The glucagon-like peptide 1 (GLP-1) receptor is a prominent target for treating type 2 diabetes and obesity. GLP-1 receptor agonists have significant therapeutic potential and market reach. Accordingly, the Company is advancing the development of various GLP-1 receptor agonists, including liraglutide injections, dual GLP-1/GIP receptor agonists, and oral small-molecule GLP-1 receptor agonists.
About THDBH110 Capsules
GLP-1 receptor agonists on the market are injections, made up of large molecules or polypeptides, with less-than-satisfactory medication adherence. The Company's THDBH110 is an oral, small-molecule alternative. Preclinical results show that the THDBH110 capsule is highly bioavailable and effective in reducing glucose levels and weight. This product not only provides a new treatment option for lowering glucose, reducing weight, and protecting cardiovascular system for type 2 diabetes and obesity patients, but also improves medication convenience and adherence. To date, no oral small-molecule GLP-1 receptor agonists have been approved globally.
As an effective hypoglycemic agent, GLP-1 receptor agonists have a promising market outlook. China ranks first globally in the number of diabetes patients, with around 140 million adult patients as per 2021 data from the International Diabetes Federation (IDF). The demand for GLP-1 receptor agonist drugs is surging. According to data from Menet.com, in 2022, the sales of GLP-1 receptor agonist drugs in Chinese public medical institutions and urban brick-and-mortar pharmacies, reached nearly RMB 6 billion, a year-on-year growth of over 100%.
GLP-1 receptor agonists, with their notable weight loss benefits and controllable side effects, are a primary recommendation in international obesity treatment guidelines. Overweight and obesity are associated with severe health risks, such as cardiovascular diseases, diabetes, and musculoskeletal disorders. As China's guidelines for treating obesity gradually align with international standards, the potential for GLP-1 receptor agonists in weight loss treatments is immense.
The clinical trial acceptance of THDBH110 marks a significant step for the Company in the R&D of GLP-1 receptor agonists. We will advance our R&D swiftly and efficiently to provide patients with more effective and safe GLP-1 receptor agonist options.
