恆瑞醫藥(600276.SH)：三藥聯合用藥擬用於治療2型糖尿病獲批臨牀試驗
格隆匯 11 月 10日丨恆瑞醫藥(600276.SH)公佈，公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《藥物臨牀試驗批準通知書》，並將於近期開展臨牀試驗。
根據《中華人民共和國藥品管理法》及有關規定，經審查，2020年8月18日受理的脯氨酸恆格列淨片(規格5mg和10mg)符合藥品註冊的有關要求，同意本品脯氨酸恆格列淨片開展與鹽酸二甲雙胍和磷酸瑞格列汀片聯合用於2型糖尿病的臨牀試驗。
根據《中華人民共和國藥品管理法》及有關規定，經審查，2020年8月18日受理的磷酸瑞格列汀片符合藥品註冊的有關要求，同意本品開展與鹽酸二甲雙胍和脯氨酸恆格列淨片聯合用於2型糖尿病的臨牀試驗。
脯氨酸恆格列淨片(SGLT2抑制劑)、鹽酸二甲雙胍和磷酸瑞格列汀片(DPP IV抑制劑)三藥聯合用藥擬用於治療2型糖尿病。經查詢，SGLT2抑制劑上市產品包括阿斯利康的達格列淨、強生的坎格列淨、勃林格殷格翰的恩格列淨和默沙東的埃格列淨，另有安斯泰來製藥的伊格列淨、中外製藥的託格列淨和大正製藥的魯格列淨僅在日本上市；DPP IV抑制劑上市產品主要包括默沙東的西格列汀、諾華的維格列汀、百時美施貴寶的沙格列汀、勃林格殷格翰的利格列汀和武田製藥的阿格列汀；三藥複方如阿斯利康的Qternmet XR（包含達格列淨、沙格列汀和二甲雙胍）於2019年獲批上市。經查詢PharMarket市場數據庫，SGLT2抑制劑2019年全球銷售額為52.59億美元，DPP IV抑制劑2019年全球銷售額為84.42億美元。
截至目前，脯氨酸恆格列淨片累計已投入研發費用約24012萬元，磷酸瑞格列汀片累計已投入研發費用約15067萬元。
根據我國藥品註冊相關的法律法規要求，藥物在獲得藥物臨牀試驗批准通知書後，尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。
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