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  2. PB-119 a long-acting GLP-1 receptor agonist

    • 產品概覽
    • 作用機理
    • 產品特點與優勢
    • 研究進展

    • PB-119 is a long-acting GLP-1 receptor agonist developed by PegBio. The phase II clinical trials of PB-119 for type 2 diabetes mellitus have been completed in China and US. The trial results demonstrated that PB-119 has remarkable effects on reducing HbA1c levels with potential benefit in weight loss and overall improvement in lipid metabolic profiling. In addition, patients receiving PB-119 treatment show good safety profile. Results from the China phase II clinical study were published in the Diabetologia in 2020.

      PB-119 is currently undergoing multiple phase III clinical trials in China, including PB-119 alone and in combination with metformin, basal insulin, or SGLT-2 inhibitor, respectively, for the treatment of type 2 diabetes mellitus. The cardiovascular outcome trial in patients with type 2 diabetes has also been approved by the CDE.

      PB-119 is intended for single-dose administration without dose titration. Along with the use of an automated disposable pen injector, PB-119 possesses the advantage of the convenience of usage that will significantly improve the quality of life of million diabetic patients.

    • PB-119是經過聚乙二醇定點修飾而成的GLP-1受體激動劑。充分保留了GLP-1受體激動劑的作用,包括改善胰島β細胞功能,葡萄糖依賴性促進胰島素分泌,低血糖風險低;誘導胰島β細胞新生和增殖,并抑制細胞凋亡,從而增加胰島β細胞數量;此外,因為GLP-1受體在多種組織細胞上均有表達,通過多種信號途徑,介導廣泛的生物功能,包括延緩胃排空、抑制肝糖輸出、增加心臟輸出、心血管保護等作用。同時,由于PB-119是經過聚乙二醇修飾過的GLP-1受體激動劑,而具有更長的半衰期,在平衡了活性,清除率和安全性的同時達到藥物長效化的目的。
    • 1) 一周一次給藥,減少用藥頻率,提升依從性
      2) 無需劑量滴定,使用簡便
      3) 潛在降脂獲益

    • 2023年完成III期臨床,2023年9月獲得NDA受理。