PEGBIO CO-B (02565) announced that China's National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) for its core product PB-119. Pidaikang® (PB-119) is a next-generation long-acting glucagon-like peptide-1 (GLP-1) receptor agonist developed by the company, administered once weekly. The product has been recognized as a national Class 1 innovative drug under China's "Major New Drug Innovation" initiative.

Clinical trials from Phase I to Phase III demonstrated that PB-119 achieves an optimal balance between effective blood glucose control and favorable tolerability, offering a high-efficacy and safe treatment option for Chinese patients with type 2 diabetes. PB-119 significantly improves β-cell function and provides comprehensive management of blood pressure, lipids, and body weight, delivering holistic benefits beyond glycemic control.

The drug's differentiated advantages stem from its unique molecular structure and pharmacological properties. Utilizing innovative site-specific PEGylation technology, PB-119 effectively resists degradation by dipeptidyl peptidase-4 (DPP-4) and significantly slows renal clearance. This structural modification enhances binding efficiency to the GLP-1 receptor while prolonging biological activity.

Additionally, PB-119 achieves relatively high release concentrations rapidly while minimizing immunogenic reactions and gastrointestinal side effects. Its design also prevents systemic accumulation risks, ensuring sustained therapeutic efficacy during clinical treatment.