恆瑞醫藥(600276.SH):子公司藥品HR20033片獲得藥物臨牀試驗批准通知書
格隆匯9月3日丨恆瑞醫藥(600276.SH)公佈,近日,公司子公司山東盛迪醫藥有限公司收到國家藥品監督管理局核准簽發關於HR20033片的《藥物臨牀試驗批准通知書》,將於近期開展臨牀試驗。
HR20033片是公司自主研發的鈉-葡萄糖協同轉運體2(SGLT2)抑制劑恆格列淨與二甲雙胍的固定劑量複方緩釋製劑。HR20033片通過兩種不同作用機制達到更好的降血糖作用。目前,國外已有多個同類複方緩釋產品上市,包括阿斯利康的XIGDUO XR、強生的INVOKAMET XR以及勃林格殷格翰和禮來合作開發的SYNJARDY XR,國內尚無同類複方緩釋產品上市。
經查詢,2020年XIGDUO XR全球銷售額約為8.30億美元,2020年SYNJARDY XR全球銷售額約為8.69億美元,暫未查詢到2020年INVOKAMET XR全球銷售數據。截至目前,HR20033片相關項目累計已投入研發費用約為745萬元。
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