财中社1月13日电石药集团(01093)发布公告,本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)已获国家药品监督管理局批准上市。该产品为一种新型口服二肽基肽酶-IV(DPP-4)抑制剂,具有高选择性和强抑制性,能够有效降低血糖水平,适用于改善成人2型糖尿病患者的血糖控制。
支持该产品获批的两项关键Ⅲ期临床试验结果显示,其具有持久的降糖作用且不易诱发低血糖和增加体重。此外,该产品的不良反应发生率及与其他药物的相互作用可能性较低,轻中度肾功能不全患者在服用时无需调整剂量。该产品的获批将为2型糖尿病患者提供新的治疗选择,并进一步丰富公司的代谢疾病产品线。
(文章来源:财中社)
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