Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., a wholly owned subsidiary of Tonghua Dongbao Pharmaceutical Co., Ltd. ("the Company"), received the notice of approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the clinical trial of THDBH120 injection for weight loss indications. The Phase Ib clinical trial for weight loss has been initiated, and the first subject was dosed recently.

The dosing of the first patient in the Phase Ib trial represents a milestone in the clinical development of THDBH120, providing a solid foundation for subsequent research. The Company will accelerate the development of THDBH120 injection for both weight loss and diabetes 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 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 5.34 billion in 2023 (2022: USD 0.48 billion) and USD 2.32 billion in 2024Q1.

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. In addition to weight loss indication, the Company has completed the first patient dosing in the Ib phase clinical trial for the diabetes indication in June 2024.

About Phase Ib Clinical Study on THDBH120 injection (a dual GLP-1/GIP receptor agonist)

Following NMPA approval, the Company has initiated 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, in accordance with the relevant guidelines for novel chemical drugs in China. The primary objective is to evaluate the safety and tolerability of THDBH120 after multiple subcutaneous injections in obese subjects, while secondary objectives include evaluating the pharmacokinetic, pharmacodynamic, and immunogenicity profiles.