鍵凱科技(688356.SH):注射用透明質酸鈉複合溶液註冊申請獲得受理
格隆匯5月28日丨鍵凱科技(688356.SH)公佈,公司全資子公司天津鍵凱科技有限公司自主研發的注射用透明質酸鈉複合溶液(藥物代碼:JK-1136H)提交註冊申請並獲國家藥品監督管理局醫療器械技術審評中心正式受理。注射用透明質酸鈉複合溶液項目是公司基於聚乙二醇修飾技術自主研發的3類無源植入型醫療器械,擬開展適應症爲成人改善皮膚乾燥、膚色暗沉。依靠透明質酸鈉的鎖水性,臨牀上可通過皮內注射實現對於真皮層的保溼補水,從而改善面部皮膚狀態。聚乙二醇是FDA批準的可用於人體注射的合成聚合物,通過懸掛的形式對透明質酸鈉進行修飾,可有效降低修飾後的透明質酸鈉在真皮內的降解速度,從而延長其保溼補水作用的時間。同時,修飾後的複合透明質酸鈉溶液流動更強,更易注射,不易漏液。
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