科倫藥業(002422.SZ):口服降糖藥琥珀酸曲格列汀片獲批上市
格隆匯3月11日丨科倫藥業(002422.SZ)公佈,公司的化學藥品“琥珀酸曲格列汀片”於近日獲得國家藥品監督管理局的藥品註冊批准。
琥珀酸曲格列汀片為武田開發的長效二肽基肽酶-4(DPP-4)抑制劑,2015年在日本首獲批,用於2型糖尿病成人患者改善血糖控制。
DPP-4抑制劑具有降糖平穩、不易誘發低血糖、胃腸道不良反應少、更適用於老年患者等優勢,已成為國內最常用的口服降糖藥之一,且已被美國糖尿病學會《糖尿病醫學診療標準(2022)》、歐洲糖尿病研究協會《糖尿病,糖尿病前期和心血管疾病(2019)》、中華醫學會糖尿病學分會《中國2型糖尿病防治指南(2020)》等國內外權威指南或專家共識推薦。
目前國內已獲批的DPP-4抑制劑均需每日服用,漏服將不利於血糖控制。公司的琥珀酸曲格列汀片為國內首個獲批可每週給藥一次的口服降糖藥,可降低患者給藥頻率,有利於提高患者用藥依從性,從而更好的控制患者血糖水平。公司在國內開展的III期臨牀研究結果表明,2型糖尿病患者每週單藥口服一次琥珀酸曲格列汀片,可有效控制患者血糖水平,且安全性與耐受性良好,可為患者提供更好的用藥選擇。
琥珀酸曲格列汀片為公司繼恩格列淨片、卡格列淨片、西格列汀片、利格列汀片後第五個獲批的糖尿病治療藥物,可進一步提升公司在糖尿病領域的管線競爭力。
2015年國家藥監政策改革,要求新申報的仿製藥必須與原研質量和療效一致。公司該次獲批的琥珀酸曲格列汀片即是按照這一要求研發,並在國內首家獲批。藥監局公佈的參比製劑信息如下:商品名:Zafatek,持證商:武田薬品工業株式會社(Takeda Pharmaceutical Co., Ltd.)。
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