恆瑞醫藥(600276.SH):HR20031片獲批開展臨牀試驗
格隆匯11月28日丨恆瑞醫藥(600276.SH)公佈,公司子公司山東盛迪醫藥有限公司收到國家藥監局核准簽發關於HR20031片的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。
HR20031片是公司開發的脯氨酸恆格列淨、磷酸瑞格列汀和鹽酸二甲雙胍(緩釋)的固定劑量三方製劑,擬每日一次口服用於治療經二甲雙胍治療後血糖仍控制不佳的2型糖尿病。HR20031片有望通過三種不同作用機制達到更好的降血糖作用。經查詢,國外已經上市的同類SGLT2抑制劑、DPPIV抑制劑和二甲雙胍緩釋三方製劑共有兩款:勃林格-禮來糖尿病聯盟的Trijardy XR(恩格列淨/利格列汀/二甲雙胍緩釋片)和阿斯利康的Qternmet XR(達格列淨/沙格列汀/二甲雙胍緩釋片),暫未查詢到相關銷售數據,國內尚無同類藥物獲批上市。截至目前,HR20031片相關項目累計已投入研發費用約913萬元。
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