Zhi Tong Cai Jing·2025-09-22 08:41Core Viewpoint - China Biopharmaceutical (01177) has received acceptance for the clinical trial application (IND) of its self-developed innovative drug TQF3250, a GLP-1 receptor agonist, intended for the treatment of type 2 diabetes [1][2] Company Summary - TQF3250 is an oral small molecule GLP-1 receptor agonist that selectively activates the cAMP-biased GLP-1R signaling pathway, effectively promoting insulin secretion while reducing β-inhibitory protein recruitment and receptor internalization, thereby extending the duration of drug efficacy [1] - Preclinical studies indicate that TQF3250 significantly improves glucose tolerance in mouse models at doses as low as 1 mg/kg, showing comparable activity to the similar drug Orforglipron, demonstrating high efficacy in glucose reduction [1] - In monkey models, the no-observed-adverse-effect level (NOAEL) for TQF3250 reached 24 mg/kg/day, with no significant cardiac or genetic toxicity risks identified, indicating good safety [1] Industry Summary - Third-party statistics show that the global market for GLP-1 receptor agonists is expected to exceed $50 billion in 2024 and is projected to surpass $150 billion by 2031 [1] - The current GLP-1 receptor agonist market is predominantly composed of injectable formulations, while TQF3250, as an oral capsule formulation, presents multiple advantages: 1. Convenient administration, significantly enhancing patient compliance 2. Stable storage, with the formulation showing stability for 24 months at 25°C 3. Metabolic safety, primarily metabolized by CYP3A enzymes, resulting in low risk of drug interactions [1] - Currently, there is only one approved oral GLP-1 receptor agonist globally, and the company aims to accelerate the clinical development of TQF3250 to provide a more convenient and effective treatment option for type 2 diabetes patients [2]