中国生物制药(01177.HK):治疗2型糖尿病药物“恩格列净片”获药品注册证书
格隆汇2月8日丨中国生物制药(01177.HK)发布公告,集团开发的治疗2型糖尿病药物“恩格列净片”(商品名:塞菲可)(规格:10mg及25mg)已获中国国家药品监督管理局颁发药品注册证书,且视同通过仿制药质量和疗效一致性评价。该产品是继卡格列净、沙格列汀、盐酸二甲双胍,集团又一个获批用于治疗糖尿病的品种,内分泌领域产品线更加丰富。
根据披露,2型糖尿病是一种进展性的疾病,随着病程的进展,对外源性的血糖控制手段的依赖逐渐增大,而现有的药物常具有不同程度的副作用,如低血糖、体重增加等。恩格列净是一种新型口服选择性钠-葡萄糖协同转运蛋白2(SGLT2)抑制剂,通过减少肾脏的葡萄糖重吸收,其降糖作用机制不依赖于胰岛素,因而造成低血糖的风险较低;还可增加热量消耗以及尿糖排泄,从而减轻体重,并有轻度的利尿作用。作为新作用机制药物,恩格列净为2型糖尿病患者的治疗带来了新的希望。格列净类药物已被美国及欧洲糖尿病学会、美国临床内分泌医师协会、国际糖尿病联盟《老年糖尿病患者治疗指南》推荐为2型糖尿病治疗一线、二线用药。
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