智通财经APP讯，石药集团(01093)公布，该集团开发的化学药品1类新药普卢格列汀片(商品名:善泽平)已获中华人民共和国国家药品监督管理局批准上市。
该产品是一种新型口服二肽基肽酶-IV(DPP-4)抑制剂，对DPP-4具有高选择性和强抑制性。通过抑制DPP-4，该产品使内源性活性胰高血糖素样肽-1(GLP-1)水平升高，从而增强β细胞和α细胞对葡萄糖的敏感性，增加葡萄糖刺激的胰岛素分泌并增强葡萄糖对胰高血糖素分泌的抑制作用，进而降低血糖水平。该产品适用于改善成人2型糖尿病患者的血糖控制(包括单药治疗和当单独使用盐酸二甲双胍仍不能有效控制血糖时的联合治疗)。
支持该产品获批的两项关键Ⅲ期临床试验(普卢格列汀片单药Ⅲ期试验和普卢格列汀片联合盐酸二甲双胍Ⅲ期试验)的试验结果均显示该产品具有持久的降糖作用且不易诱发低血糖和增加体重。此外，该产品不良反应发生率和与其他药物发生相互作用的可能性较低，轻中度肾功能不全患者服用该产品时无需调整剂量。
该产品的获批将为2型糖尿病患者提供新的治疗选择，同时进一步丰富集团在代谢疾病领域的产品线。
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