通化東寶(600867.SH):超速效賴脯胰島素注射液(BCLispro)申報平行開展III期臨牀與Ⅰ期臨牀獲得批准
格隆匯10月13日丨通化東寶(600867.SH)公佈,公司於2021年3月28日向國家藥品監督管理局藥品審評中心(“CDE”)提交的關於超速效賴脯胰島素注射液(THDB0206)在中國平行開展Ⅲ期臨牀試驗與Ⅰ期臨牀試驗的Ⅱ類溝通交流會議申請,於近日獲得CDE審核批准。
截至公吿日,公司在該項目中已投入研發費用人民幣約4771.88萬元。
超速效賴脯胰島素注射液(THDB0206)是在第三代餐時胰島素類似物製劑(賴脯胰島素注射液)的基礎上通過新的製劑技術進行改良獲得。早期研究顯示其與第三代餐時胰島素類似物製劑相比,皮下注射給藥後賴脯胰島素的吸收速度更快,早期暴露更高而總體暴露相似,從而導致降血糖活性出現的更早、早期降糖效應更強,但總體降糖活性相當,與賴脯胰島素注射液相比的時間-暴露曲線、時間-效應曲線顯示出“左移”特徵,該特徵和國外已上市的Fiasp®和Liumjev®相似,符合生理性胰島素分泌模式。
與國外患者相比,中國糖尿病患者的早期時相胰島素分泌不足尤為顯著,超速效賴脯胰島素注射液(THDB0206)的這些特性預期可重塑胰島素的早相分泌,產生更快速、平穩的降糖效應,同時降低與內源性胰島素延遲分泌和/或外源性胰島素延遲吸收疊加所致的潛在餐後晚期低血糖風險。此外還能夠為患者提供更方便、靈活的給藥時機。
超速效賴脯胰島素注射液(THDB0206)屬於新一代速效胰島素類似物產品,目前全球範圍內的同類藥品僅有丹麥諾和諾德公司的Fiasp®和美國禮來公司的Liumjev®,它們的顯著特點是更快更好的藥物吸收、從而使胰島素更迅速的起效,與餐後生理性胰島素分泌更為接近。目前Fiasp®和Liumjev®尚未在中國上市。
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