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Tonghua Dongbao announces NMPA acceptance of its clinical trial application for dual GLP-1/GIP receptor agonist (THDBH121 injection)
Date：2023-01-17
Author：尊龙凯时
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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. CXHL2300068, CXHL2300069, and CXHL2300070) 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 (THDBH121 injection).
Keeping up with the global trend in R&D of peptide-based weight-loss and antidiabetic drugs, Tonghua Dongbao is betting on multi-agonist and long-acting novel drugs. As the Company's key novel drug under development, THDBH121 injection is a glucagon-like peptide 1 (GLP-1) receptor and glucose-dependent insulinotropic polypeptide (GIP) receptor dual-target agonist with a new chemical structure.
Tirzepatide (trade name: Mounjaro; indication: type 2 diabetes in adults), a comparable drug to the THDBH121 injection and the world's first dual GLP-1/GIP receptor agonist, achieved global sales of more than USD 200 million in just over four months after it was approved by the FDA in May 2022. This heralds a lucrative market for THDBH121. According to Refinitiv, Tirzepatide sales are expected to reach USD 4.7 billion by 2026. So far, no dual GLP-1/GIP receptor agonist has been approved in China.
In addition to type 2 diabetes, the Company will explore other indications for THDBH121 injection in the future, such as obesity, so as to tap into new markets and maximize the product value. Meanwhile, the comparable drug Tirzepatide has advanced to the Phase III clinical trial on its efficacy in obesity treatment.
About dual GLP-1/GIP receptor agonist (THDBH121 injection)
THDBH121 injection 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, and regulation of lipid metabolism, etc. It meets the clinical needs of diabetic patients who are no better after treatment with single molecular targets or compounded preparations. THDBH121 injection is expected to become a more long-acting blockbuster drug for the treatment of diabetes and obesity.
