Tonghua Dongbao Pharmaceutical Co., Ltd. (hereinafter referred to as "the Company" or "Tonghua Dongbao"), a wholly-owned subsidiary Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., received the approval notice for the clinical trial of injectable THDBH120 (GLP-1/GIP dual receptor agonist) from the National Medical Products Administration Drug Evaluation Center. The company has initiated the Phase I clinical trial and recently completed the enrollment of the first subject.

After the approval for clinical use of injectable THDBH120, the company completed the enrollment of the first subject in the Phase I clinical trial in just around half a month, showcasing the company's accelerated progress in the research and development of innovative products, as well as its ability and determination to transition into an innovative pharmaceutical enterprise. The company will further explore and uncover the potential of injectable THDBH120 in other indications such as obesity, continually opening up new therapeutic areas to maximize the value of the product.

Injectable THDBH120 holds immense future market potential as the world's first GLP-1/GIP dual receptor agonist, similar to the rapid sales growth observed after the launch of Tirzepatide. Tirzepatide (brand name: Mounjaro) injection was approved for sale by the FDA and EMA in 2022, and its global sales reached $2.957 billion in the first three quarters of 2023. Currently, there are no domestically approved GLP-1/GIP dual receptor agonists on the market in China.

About Injectable THDBH120 (GLP-1/GIP Dual Receptor Agonist)

Injectable THDBH120 is a dual-target agonist for glucagon-like peptide-1 (GLP-1) receptor and glucose-dependent insulinotropic polypeptide (GIP) receptor, which is a key focus of the company's research and development efforts. It belongs to the category of innovative drugs. By integrating the effects of GLP-1 and GIP into a single peptide molecule and enhancing metabolic stability through further molecular design, it aims to improve blood sugar control and meet the clinical needs of diabetes patients for whom single-target or combination formulations have shown inadequate therapeutic effects. Injectable THDBH120 is expected to become a long-acting blockbuster drug for the treatment of diabetes.

About Phase I Clinical Trial of Injectable THDBH120 (GLP-1/GIP Dual Receptor Agonist)

After obtaining approval for clinical trials from the National Medical Products Administration, the applicant has initiated a Phase I clinical study titled "Evaluation of the Safety, Tolerance, Pharmacokinetics, and Pharmacodynamics of Injectable THDBH120 in Healthy Chinese Adults: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Escalation Study" in accordance with relevant guidelines for the innovation of chemical drugs in China. The primary objective is to assess the safety and tolerance of single and multiple subcutaneous injections of THDBH120 in healthy adults, and secondary objectives include evaluating the pharmacokinetic/pharmacodynamic characteristics and immunogenicity after single and multiple subcutaneous injections of THDBH120 in healthy adults.

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