通化東寶(600867.SH):可溶性甘精賴脯雙胰島素注射液(THDB0207注射液)德國I期臨牀試驗申請獲得批准
格隆匯4月11日丨通化東寶(600867.SH)公佈,公司於近日取得德國監管機構(BfArM)對BioChaperone®Combo(簡稱“BCCombo”),即可溶性甘精賴脯雙胰島素注射液(THDB0207注射液),三項I期臨牀試驗的批准。
截至公吿日,公司在該項目中的研發投入人民幣約3552.06萬元。
上述三項即將在德國啟動的I期臨牀試驗將使得可溶性甘精賴脯雙胰島素注射液能夠在獲得全球領先技術標準下的鉗夾研究數據的基礎上,更快完成支持Ⅲ期臨牀試驗的早期臨牀藥理學研究。
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。
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