中国生物制药(01177.HK):降糖药"沙格列汀片"获批上市
格隆汇 9 月 14日丨中国生物制药(01177.HK)宣布,集团开发的治疗2型糖尿病药物"沙格列汀片"(商品名:贝斯宁)已获中华人民共和国国家药品监督管理局颁发药品注册证书,为该品种仿制药国内第二家获批,且视同通过仿制药质量和疗效一致性评价。贝斯宁获批上市,将进一步丰富和完善集团在糖尿病领域的产品线布局。
沙格列汀是一种强效选择性二肽基肽酶-4(DPP-4)抑制剂,可通过抑制DPP-4,延长内源性胰高血糖素样肽-1(GLP-1)和葡萄糖依赖性促胰岛素多肽(GIP)的作用时间从而调节血糖,主要用于治疗2型糖尿病。与传统降糖药物相比,DPP-4抑制剂的优势在于不增加低血糖风险、对体重影响中性、心血管安全性良好。
丰富的临床试验表明,沙格列汀片无论从安全性、有效性、质量可控性等方面均有显着优点;其临床定位明确、应用广泛,已被纳入国家医保目录(乙类),作为抗糖尿病药物将具有十分广阔的市场前景。
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