聯邦製藥(03933.HK):UBT251注射液CKD適應症獲美國FDA批準新藥臨牀試驗
格隆匯3月3日丨聯邦製藥(03933.HK)公告,近日,公司全資附屬公司聯邦生物科技(珠海橫琴)有限公司自主研發的1類創新藥UBT251注射液獲得美國藥品監督管理局("FDA")許可,同意開展慢性腎臟病("CKD")適應症II期臨牀試驗。此前,CKD適應症已於2025年1月二十日獲得中國國家藥品監督管理局臨牀試驗批準。
根據臨牀前肥胖/糖尿病腎病藥效模型,UBT251對腎臟尿白蛋白等相關腎損傷標誌物和組織病理的整體改善效果明顯優於司美格魯肽(Semaglutide)。未來有望爲代謝相關慢性腎病的治療提供新選擇,進一步滿足臨牀用藥需求。
UBT251是一款長效GLP-1(胰高血糖素樣肽-1)/GIP(葡萄糖依賴性促胰島素多肽)/GCG(胰高血糖素)三靶點受體激動劑,公司是中國首家、全球第二家以化學合成多肽法制備的長效GLP-1/GIP/GCG三激動劑獲準臨牀試驗的企業。目前,成人2型糖尿病、超重或肥胖、CKD等多個適應症已取得中國及美國兩地藥物臨牀試驗批準,並已於中國率先進入臨牀試驗階段。
未來,公司將持續致力於新產品研發,並重點提升在生物醫藥行業的競爭力及創造力,預期將爲公司及其股東創造更大收益。
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