Core Viewpoint - The China National Medical Products Administration has approved the new drug application for PB-119, a novel long-acting GLP-1 receptor agonist developed by the company, providing an effective and safe treatment option for type 2 diabetes patients in China [1] Group 1: Product Details - PB-119 is recognized as a Class 1 new drug and is part of a major national science and technology project for "major new drug creation" [1] - The drug demonstrates an optimal balance between effective blood sugar control and good tolerability based on clinical studies [1] - PB-119 significantly improves β-cell function and manages blood pressure, blood lipids, and weight, achieving comprehensive benefits for patients [1] Group 2: Unique Features - The drug's differentiated advantages stem from its unique molecular structure and pharmacological properties [1] - Utilizing innovative site-specific PEGylation technology, PB-119 effectively resists DPP-4 degradation and significantly delays renal clearance [1] - This structural modification allows for efficient binding to GLP-1 receptors and biological effects, while minimizing immune responses and gastrointestinal side effects [1]
派格生物医药-B(02565)：中国国家药监局批准PB-119新药上市申请