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中国生物制药(01177):TQF3250胶囊“GLP-1受体激动剂”临床试验申请获NMPA受理
智通财经网· 2025-09-22 08:43
Core Insights - China Biopharmaceutical's self-developed innovative drug TQF3250, a GLP-1 receptor agonist, has received acceptance for clinical trial application from the National Medical Products Administration (NMPA) in China, aimed at treating type 2 diabetes [1][2] - TQF3250 is an oral small molecule GLP-1RA 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 at doses as low as 1 mg/kg in mouse models, showing comparable efficacy to the similar drug Orforglipron [1] - In monkey models, TQF3250's no-observed-adverse-effect level (NOAEL) reached 24 mg/kg/day, with no significant cardiac or genetic toxicity risks identified, indicating good safety [1] Market Potential - Third-party statistics show that the global GLP-1RA market is expected to exceed $50 billion in 2024 and surpass $150 billion by 2031 [1] - The current GLP-1RA market is predominantly composed of injectable formulations, while TQF3250, as an oral capsule, presents multiple advantages: 1. Convenient administration, significantly enhancing patient compliance 2. Stability in storage, with the formulation showing stability for 24 months at 25ºC 3. Metabolic safety, primarily metabolized by CYP3A enzymes, resulting in low risk of drug interactions [1] Development Strategy - The company aims to accelerate the clinical development of TQF3250 to provide a more convenient and effective treatment option for patients with type 2 diabetes [2]
中国生物制药(01177.HK):TQF3250胶囊“GLP-1受体激动剂”临床试验申请获NMPA受理
Ge Long Hui· 2025-09-22 08:42
Core Viewpoint - China National Pharmaceutical Group (01177.HK) has received acceptance for the clinical trial application (IND) of its self-developed innovative drug TQF3250, a GLP-1 receptor agonist, from the National Medical Products Administration (NMPA) in China, aimed at treating type 2 diabetes [1]. Group 1 - TQF3250 is an oral small molecule GLP-1 receptor agonist that selectively activates the cAMP-biased GLP-1R signaling pathway [1]. - The drug effectively promotes insulin secretion while reducing the recruitment of β-inhibitory proteins and receptor internalization, thereby extending the duration of its efficacy [1].
中国生物制药:TQF3250胶囊“GLP-1受体激动剂”临床试验申请获NMPA受理
Zhi Tong Cai Jing· 2025-09-22 08:41
Core 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]