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Tonghua Dongbao announces NMPA acceptance of clinical trial application for dual GLP-1/GIP receptor agonist (THDBH120 injection) intended for weight loss indications
Date：2024-02-07
Author：東寶
Views：2
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 from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the clinical trial of the dual GLP-1/GIP receptor agonist (THDBH120 injection) intended for weight loss indications.
This not only marks a significant step forward in the product's development for multiple indications, but also indicates the Company's expansion into the field of overweight and obesity treatment—a milestone for its GLP-1 drug pipeline. The Company will accelerate the development of THDBH120 injection for both diabetes and weight loss indications, while exploring other potential uses to maximize the product's value.
The future market of THDBH120 injection is promising. A comparable product, Tirzepatide, the world's first dual GLP-1/GIP receptor agonist, has seen rapid sales growth since its launch. Tirzepatide for diabetes (trade name: Mounjaro) was approved by the FDA and EMA in 2022, and its global sales in the first three quarters of 2023 reached around USD 2.957 billion. Its weight loss version (trade name: Zepbound) received FDA approval in November 2023.
About THDBH120 injection (a dual GLP-1/GIP receptor agonist)
The development of peptide-based weight-loss and antidiabetic drugs increasingly focuses on multi-agonist and long-acting novel drugs. THDBH120 injection is a dual-target agonist that acts on both the glucagon-like peptide-1 (GLP-1) receptor and the glucose-dependent insulinotropic polypeptide (GIP) receptor. This drug integrates the effects of two incretins, GLP-1 and GIP, into a polypeptide monomer and improves metabolic stability through molecular design, synergistically promoting blood glucose control, weight loss, regulation of lipid metabolism, etc. It meets the clinical needs of diabetic patients who report poor effects of treatment with single molecular targets or compounded preparations. THDBH120 injection is expected to become a more long-acting blockbuster drug for treatment of diabetes and obesity.
So far, no dual GLP-1/GIP receptor agonist has been approved for marketing in China. The Company's THDBH120 injection for diabetes is now in Phase Ia clinical trial.
About overweight and obesity
In recent years, nearly 90% of deaths in China were caused by chronic non-infectious diseases such as cardiovascular diseases, diabetes, and certain cancers. These have become major public health issues both in China and around the world. Overweight and obesity are primary risk factors for these diseases. According to the Report on Chinese Residents' Chronic Diseases and Nutrition (2020), over 50% of Chinese adults are either overweight or obese, with 34.3% overweight and 16.4% obese. Currently, lifestyle interventions are the primary approach to managing overweight and obesity, but some patients still need drug treatment to reach their weight loss goals. There is a huge demand for safe and effective weight-loss drugs.
