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Tonghua Dongbao's THDBH120 Injection Meets Primary Endpoint in Phase Ib Trial for Type 2 Diabetes, Reducing HbA1c by 1.38% in Six Weeks
Date：2025-02-27
Author：東寶
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Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. ("the Company" or "Tonghua Dongbao"), completed a Phase Ib pivotal clinical trial on THDBH120 injectionand produced a clinical trial report. The results demonstrate that the trial has reached its primary endpoint.
Tonghua Dongbao announced that its dual GLP-1/GIP receptor agonist, THDBH120 injection, has met the primary endpoint in a Phase Ib clinical trial for type 2 diabetes. This marks a significant milestone in the Company's development of innovative GLP-1 therapies. The drug showed good safety and tolerance in subjects with type 2 diabetes, along with a favorable pharmacokinetic profile and significant reduction in HbA1c levels.
Key clinical trial results:
The drug demonstrated good safety and tolerance after multiple doses; gastrointestinal adverse effects were consistent with those of similar products.
In subjects with type 2 diabetes, the least squares mean reduction in HbA1c from baseline ranged from –1.01% to –1.38% at Week 4 (for once-weekly dosing) or Week 6 (for once-biweekly dosing) after the first dose.
A fixed weekly dose of 1 mg lowered HbA1c by more than 1% within 4 weeks.
By the end of treatment, daytime average blood glucose levels dropped to 5.6–7.4 mmol/L, with a maximum reduction of 51.7%.
Other metabolic indicators, including body weight and blood lipids, also improved significantly compared with the placebo group.
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 weight loss version (trade name: Zepbound) received FDA approval in November 2023. According to financial reports from Lilly, the global sales of Tirzepatide amounted to USD 16.47 billion in 2024 (2023: USD 5.34 billion), representing a year-on-year increase of approximately 208%. The company's THDBH120 for injection, as a dual-agonist targeting both GLP-1 and GIP receptors, covers both diabetes and weight loss indications and has a huge market potential.
In the future development plan, the company will not only accelerate the research and development progress of THDBH120 for injection in the indications of weight loss and diabetes, but also further explore and tap the potential of the drug in other indications.
Phase Ib Clinical Trial Results of THDBH120 Injection (Dual GLP-1/GIP Receptor Agonist)
Following NMPA approval for clinical trials of THDBH120 injection, the Company, in accordance with the relevant guidelines for novel chemical drugs in China, recently completed a randomized, double-blind, placebo-controlled Phase Ib clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of THDBH120 injection in Chinese obese subjects. The study results achieved the primary endpoint objectives. The clinical trial results show that the pharmacokinetic profile of THDBH120 in subjects with type 2 diabetes was similar to that in healthy individuals. Its half-life was significantly longer than that of tirzepatide, which targets the same receptors. THDBH120 demonstrated good safety and tolerance after multiple doses. No subjects discontinued treatment or withdrew due to adverse events. Gastrointestinal side effects, such as nausea and vomiting, were mostly mild to moderate (Grade 1 or 2) and consistent with those observed in similar products.
Subjects received either once-weekly dosing regimens (1-1-1-1 mg, 1-1-2-4 mg, or 1-2-4-8 mg) or a biweekly regimen (2-4-8 mg). At the end of treatment (Week 4 or Week 6 after the first dose), the least squares mean reduction in HbA1c from baseline ranged from –1.01% to –1.38%. THDBH120 significantly reduced HbA1c levels compared with placebo (p < 0.05). By comparison, published data on tirzepatide show that once-weekly regimens (5-5-5-5 mg, 5-5-10-10 mg, or 5-5-10-15 mg) resulted in HbA1c reductions of –0.46% to –1.00% after four weeks in subjects with type 2 diabetes. THDBH120 achieved a reduction of over 1% with a fixed weekly dose of 1 mg after four weeks, demonstrating a stronger glucose-lowering effect. THDBH120 also lowered both fasting and postprandial blood glucose. Based on 7-point SMBG profiles, daytime average blood glucose levels dropped to 5.6–7.4 mmol/L by the end of treatment, with a maximum reduction of 51.7% from baseline. Other metabolic indicators, including body weight and blood lipids, also improved significantly compared with the placebo group. These results demonstrate that THDBH120 has a favorable benefit-risk profile, supporting its continued clinical development.
About THDBH120 Injection (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.
