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科倫藥業(002422.SZ):注射用SKB315用於開展晚期實體瘤的臨牀試驗獲批
格隆匯 11-04 17:36

格隆匯11月4日丨科倫藥業(002422.SZ)公佈,公司近日獲悉,公司控股子公司四川科倫博泰生物醫藥股份有限公司開發的創新藥物注射用SKB315獲得國家藥品監督管理局(NMPA)臨牀試驗通知書。

審評結論:根據《中華人民共和國藥品管理法》及有關規定,經審查,2021826日受理的注射用SKB315符合藥品註冊的有關要求,同意按照提交的方案開展晚期實體瘤的臨牀試驗

注射用SKB315是公司開發的全新的具有自主知識產權的靶向Claudin18.2ADC藥物,擬用於治療晚期實體瘤。

截至公吿披露日,全球尚未有獲批上市的同靶點ADC藥物,目前同靶點單克隆抗體研發進度最領先的為安斯泰來的Claudin18.2單抗Zolbetuximab,處於胃和胃食管交界腺癌的III期臨牀試驗階段。

本品通過人源化抗Claudin18.2抗體特異性地識別並結合腫瘤細胞表面的Claudin18.2後,被腫瘤細胞內吞,在胞內釋放毒素分子,毒素分子通過阻滯腫瘤細胞週期,抑制腫瘤細胞增殖,從而誘導腫瘤細胞凋亡,發揮抗腫瘤效應;同時注射SKB315具有抗體依賴性細胞毒性(ADCC)和補體依賴性細胞毒性(CDC)殺傷腫瘤細胞,並且通過旁觀者效應介導對周圍非靶細胞的殺傷。

非臨牀研究結果顯示,注射用SKB315在胃癌、胰腺癌等多種CDXPDX腫瘤模型中藥效顯著,呈劑量依賴地抑制腫瘤生長。非臨牀安全性評價顯示,注射用SKB315副反應較少,表現出良好的安全性。

截至目前,公司在注射用SKB315整體項目已投入約4631萬元人民幣研發費用。

公司將按照國家藥品監督管理局簽發的臨牀試驗通知書的要求,組織實施注射SKB315的臨牀試驗

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