信達生物(01801.HK):國家藥監局受理替妥尤單抗的新藥上市申請用於治療甲狀腺眼病
格隆匯5月21日丨信達生物(01801.HK)發佈公吿,中國國家藥品監督管理局(“NMPA”)藥品審評中心(“CDE”)已經正式受理替妥尤單抗注射液(重組抗胰島素樣生長因子1 受體(“IGF-1R”)抗體,研發代號:IBI311)的新藥上市申請(“NDA”),用於甲狀腺眼病(“TED”)的治療。
此次NDA獲受理是基於一項在中國TED受試者中開展的3期註冊臨牀研究RESTORE-1(CTR20223393)的積極結果。該研究於2024年2月順利達成主要研究終點,研究顯示IBI311組研究眼的眼球突出度、疾病活動程度和受試者生活質量等方面的改善均顯著優於安慰劑組。研究治療期間,替妥尤單抗整體安全性良好,未發現新的安全性信號。RESTORE-1研究的詳細數據計劃將在2024年學術大會和學術期刊上公佈。
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