Core Viewpoint - The approval of PB-119 by the National Medical Products Administration of China marks a significant milestone for the company, positioning it as a new treatment option for type 2 diabetes patients in China [1] Group 1: Product Information - PB-119 is a next-generation long-acting GLP-1 receptor agonist that requires weekly administration [1] - It is recognized as a "major new drug creation" under a national science and technology major project, classified as a category 1 original drug [1] - Clinical studies (Phase I to III) indicate that PB-119 achieves an optimal balance between effective blood sugar control and good tolerability, providing a high-efficiency and safe treatment option for type 2 diabetes patients in China [1] Group 2: Therapeutic Benefits - PB-119 significantly improves β-cell function and manages blood pressure, blood lipids, and weight, achieving comprehensive management of "four highs" [1] - The drug's unique molecular structure and pharmacological properties contribute to its differentiated advantages [1] Group 3: Mechanism of Action - The innovative site-specific PEGylation technology allows PB-119 to effectively resist degradation by DPP-4 and significantly delay renal clearance [1] - This structural modification enables efficient binding to GLP-1 receptors and biological effects, allowing for a relatively high release concentration in a short time [1] - PB-119 minimizes immune responses and gastrointestinal side effects, avoiding the risk of accumulation in the body, thus maintaining a longer duration of efficacy during clinical treatment [1]
派格生物医药-B(02565.HK)：中国国家药监局批准PB-119新药上市申请