華東醫藥(000963.SZ)：道爾生物注射用DR10624獲新西蘭Medsafe及HDEC臨牀試驗批准通知書
格隆匯4月7日丨華東醫藥(000963.SZ)公佈，2022年4月6日，公司控股子公司浙江道爾生物科技有限公司(“道爾生物”)獲得新西蘭藥品和醫療器械安全管理局(Medsafe)、健康及殘疾倫理委員會(HDEC)的最終批准，獲准在當地開展注射用DR10624的I期臨牀試驗。
DR10624為全球首創(first-in-class)的一種靶向GLP-1受體(GLP-1R)、GCG受體(GCGR)和FGFR1c/Klothoβ (FGF21R)的長效三靶點激動劑。由N端靶向GLP-1R/GCGR的嵌合肽段與工程化改造的IgG1Fc融合，並在Fc的C末端融合重組的FGF21突變體。DR1024由中國倉鼠卵巢(CHO)細胞表達，經純化後獲得。DR10624結構上為對稱二聚體，具有GLP-1R、GCGR與FGF21R三重激動劑的生物學活性，同時融合有去糖基化改造的IgG1Fc以延長半衰期。臨牀前的動物研究顯示，DR10624具有明顯的降糖、降脂、減重等療效。
目前全球尚無同時靶向GLP-1R、GCGR和FGF21R的長效三靶點激動劑藥物上市，本次注射用DR10624獲准在新西蘭開展I期臨牀試驗，是道爾生物首個在海外獲批的臨牀試驗申請，也是全球第一個進入臨牀研究的同時靶向GLP-1R、GCGR和FGF21R的長效三靶點激動劑。此次DR10624在新西蘭的臨牀試驗獲批，將豐富公司在內分泌治療領域的產品儲備，增加公司在創新藥和內分泌疾病治療領域用藥的覆蓋範圍，加速公司融入全球創新醫藥產業的步伐，進一步提升公司綜合競爭力。
此次道爾生物注射用DR10624獲得新西蘭Medsafe及HDEC臨牀試驗批准通知書，是該款新藥研發進程中的一大重要進展。對公司當期業績不會產生重大影響，長期來看有利於推進產品研發及上市進度，進一步提升公司的核心競爭力。
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