聯邦制藥(03933.HK):索瑪魯肽注射液臨牀試驗申報獲國家藥品監督管理局受理
格隆匯6月30日丨聯邦制藥(03933.HK)公吿,於2021年6月29日,公司全資附屬公司珠海聯邦制藥股份有限公司("珠海聯邦")接獲國家藥品監督管理局關於珠海聯邦申報的索瑪魯肽注射液的臨牀試驗受理通知書,受理號為CXSL2101157。
索瑪魯肽是長效胰高血糖素樣肽-1(GLP-1)類似物,用於二型糖尿病的治療。通過促進胰島細胞分泌胰島素顯著降低體內血糖,減輕患者體重,同時具有明顯的心血管獲益。索瑪魯肽是目前已上市同靶點藥物中降糖效果最顯著的GLP-1類似物,一週僅需注射一次,具有安全、簡便、療效顯著等特點。除二型糖尿病適應症外,目前包括減重、非酒精性脂肪性肝炎(NASH)、阿爾茲海默症等多個適應症在研究中。
公司作為以生物類似藥申報索瑪魯肽臨牀試驗的首仿企業,將持續致力於新產品的研發,並重點提升在生物醫藥行業的競爭力及創造力,預期將為公司及其股東創造更大收益。
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