SINO BIOPHARM (01177) announced that the Investigational New Drug (IND) application for its self-developed Class 1 innovative drug TQF3250 capsule, a "GLP-1 Receptor Agonist (GLP-1RA)," has been accepted by China's National Medical Products Administration (NMPA) for the treatment of Type 2 diabetes.

TQF3250 is an oral small-molecule biased GLP-1RA that selectively activates the cAMP-biased GLP-1R signaling pathway, efficiently promoting insulin secretion while reducing β-arrestin recruitment and receptor internalization, thereby extending the duration of drug efficacy.

Preclinical studies demonstrate that in mouse models, TQF3250 significantly improved glucose tolerance at doses as low as 1 mg/kg, with activity comparable to the similar drug Orforglipron, showing highly effective glucose-lowering effects. In cynomolgus monkey models, TQF3250 achieved a No Observed Adverse Effect Level (NOAEL) of 24 mg/kg/day, with no significant cardiac toxicity or genotoxicity risks identified, indicating good safety profile.

Third-party statistics show that the global GLP-1RA drug market exceeded $50 billion in 2024 and is projected to surpass $150 billion by 2031. The current GLP-1RA drug market remains dominated by injectable formulations. As an oral capsule formulation, TQF3250 demonstrates multiple advantages: 1. Convenient administration: oral dosing can significantly improve patient compliance; 2. Storage stability: trials show the formulation remains stable for 24 months at 25°C; 3. Metabolic safety: primarily metabolized by CYP3A enzymes with low drug interaction risk.

Currently, only one oral GLP-1RA has received global market approval. The group will accelerate the clinical development of TQF3250 to provide more convenient and effective treatment options for Type 2 diabetes patients.