中國生物製藥(01177.HK)卡格列淨片獲藥品註冊證書
格隆匯10月9日丨中國生物製藥(01177.HK)發佈公告,集團開發的治療2型糖尿病藥物“卡格列淨片”(商品名:賽力平)已獲中國國家藥品監督管理局頒發藥品註冊證書,為該品種仿製藥國內第二家獲批,且視同通過仿製藥質量和療效一致性評價。獲批准的適應症為:當二甲雙胍單獨使用血糖控制不佳時,可與二甲雙胍聯合使用;及當二甲雙胍和磺脲類藥物聯用血糖控制不佳時,可與二甲雙胍和磺脲類藥物聯合使用;並配合飲食和運動,改善成人2型糖尿病患者的血糖控制。
卡格列淨是一種新型的鈉-葡萄糖協同轉運蛋白2(SGLT2)抑制劑,通過降低腎臟對葡萄糖的重吸收,增加尿中葡萄糖排出量來降低血糖值。SGLT2抑制劑與其他抗糖尿病藥物相比,主要具有以下優勢:(1)使用範圍較廣,尤其適用於腎性糖尿病患者的血糖改善;(2)不易引起低血糖,能改善胰島β細胞功能,改進胰島素抵抗;(3)減少水鈉瀦留的可能性,並降低引起心血管類疾病的風險;(4)副作用較少。格列淨類藥物已被美國及歐洲糖尿病學會、美國臨牀內分泌醫師協會等推薦為2型糖尿病治療的一線╱二線用藥。研究證明,卡格列淨對二甲雙胍血糖控制不佳的2型糖尿病患者的效果優於格列美脲和西格列汀,且不良反應小,不易發生藥物間相互作用。
公司表示,集團已上市的治療糖尿病藥物有DPP-4(二肽基肽酶-4)抑制劑沙格列汀和西格列汀。賽力平(卡格列淨片)的獲批上市,進一步豐富了集團內分泌領域產品線,提供更多臨牀用藥選擇,惠及廣大糖尿病患者,將帶來較大的社會和經濟效益。
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