甘李藥業(603087.SH):GZR18獲得美國FDA藥品臨牀試驗批准
格隆匯12月6日丨甘李藥業(603087.SH)公佈,近日,公司全資子公司甘李藥業美國公司獲得美國食品藥品監督管理局(簡稱“FDA”)同意GZR18進行I期臨牀試驗的批准(IND154969)。子公司將在美國開展該項I期臨牀試驗。
該藥品為每週注射一次的胰高血糖素樣肽1(GLP-1)受體激動劑類藥物,本次向FDA申請的臨牀試驗適應症為II型糖尿病。Grand View Research發佈的報吿顯示,全球GLP-1受體激動劑市場份額在2019年達到113億美元,預計到2027年可達181億美元。
目前全球範圍內已獲批一週注射一次的GLP-1受體激動劑藥物主要有度拉糖肽(禮來)、司美魯肽(諾和諾德)和聚乙二醇洛塞那肽(豪森,僅中國獲批)等。截至2021年9月30日,甘李藥業在該項目中累計投入研發費用5812萬元人民幣。
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