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Tonghua Dongbao: First subject enrolled in phase I clinical trial of the world's first triple-target inhibitor (SGLT1/ SGLT2/ DPP4)
Date：2022-03-01
Author：東寶
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Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd. ("Dongbao Zixing"), a wholly-owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. (the "Company" or "Tonghua Dongbao") has initiated the phase I clinical trial of its triple-target inhibitor (THDBH101 Tablets/WXSHC071 Tablets) in China, after receiving the notice of approval from the National Medical Products Administration (NMPA). Recently, the first subject has been successfully enrolled.
THDBH101 Tablets are the world's first orally delivered, small-molecule SGLT1/SGLT2/DPP4 triple-target inhibitor that has entered clinical trials.
On the basis of the conventional, mature mechanism of SGLT2, this novel drug enhances the anti-hyperglycemic effect through the combination of SGLT1 and DPP4. When SGLT1 cuts a striking figure in regulating intestinal glucose absorption, DPP4 ensures a more stable and lasting anti-hyperglycemic effect. The drug will be a safer and more effective option for patients with type 2 diabetes to control blood sugar. It is also expected to benefit the cardiovascular system, kidney, liver and other organs.
In accordance with relevant guidelines for China's novel drugs, the Company will conduct a randomized, double-blind, placebo-controlled, crossover clinical trial that incorporates single- and multiple-dose, dose-escalation, and food-effect study in the phase 1. The primary objective of the trial is to assess the safety and tolerability of THDBH101 in healthy Chinese adults; the additional objectives are to evaluate THDBH101's pharmacokinetic profile and metabolism, and explore the pharmacodynamic indicators in healthy Chinese adults.
The Company has been dedicated to extending the R&D pipelines and improving R&D efficiency on its way to becoming an explorer and leader of novel drugs R&D. As the world's first SGLT1/ SGLT2/ DPP4 triple-targeted inhibitor, THDBH101 is the Company's first Class 1 new drug that has entered the phase 1 clinical trial with first subject enrollment completed. It marks a milestone for the Company's novel drugs R&D journey. It not only makes a good start for a new chapter of innovation, transformation and development of the Company in 2022, but paves the way for other novel drugs, such as GLP-1/GIP dual-target receptor agonists in the field of diabetes treatment, GLP-1 oral receptor agonists, and URAT1 inhibitors in the field of gout treatment. Tonghua Dongbao will continue to keep a finger on the pulse of the cutting-edge and key technologies in diabetes and endocrine treatment, in a bid to build a world-class R&D and commercialization platform.
