通化東寶(600867.SH):THDB0207注射液德國I期臨牀試驗完成首例受試者入組
格隆匯5月18日丨通化東寶(600867.SH)公佈,公司收到德國監管機構(BfArM)簽發的關於可溶性甘精賴脯雙胰島素注射液(THDB0207注射液)三項I期臨牀試驗批准通知書後,已經啟動德國I期臨牀試驗,並於近日成功完成CT046-ADO05試驗的首例受試者入組。
可溶性甘精賴脯雙胰島素注射液通過添加新型輔料,使甘精胰島素和賴脯胰島素能在中性pH值下形成穩定的雙胰島素複方製劑,其餐時相吸收、起效快,轉換相疊加作用小,基礎相效應持續久的藥代動力學和藥效學特徵,有望實現與基礎胰島素比較,能更好的兼顧空腹和餐後血糖控制,與預混胰島素比較,能夠強化空腹血糖控制、減少“肩效應”引發的低血糖風險、使用更方便。
可溶性甘精賴脯雙胰島素注射液屬於目前唯一能將長效甘精胰島素和速效賴脯胰島素成功組合的複方製劑。目前全球範圍內的雙胰島素產品僅有諾和諾德公司的德谷門冬雙胰島素注射液(商品名稱:諾和佳®、Ryzodeg®),Ryzodeg®於2012年起陸續在日本、歐洲和美國等多個地區上市,2019年5月在中國獲批上市,中文商品名為諾和佳®。
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