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華海藥業(600521.SH):HOT-1030注射液獲藥物臨牀試驗許可
格隆匯 09-25 15:38

格隆匯9月25日丨華海藥業(600521.SH)公佈,近日,公司的下屬子公司華博生物醫藥技術(上海)有限公司(以下簡稱“華博生物”)及上海華奧泰生物藥業股份有限公司(以下簡稱“華奧泰”)收到國家藥監局核准簽發的HOT-1030注射液項目的《藥物臨牀試驗批准通知書》。

HOT-1030注射液是一種以CD137(4-1BB)為靶點的單克隆抗體,擬用於治療晚期惡性實體腫瘤。CD137,又名4-1BB,是腫瘤壞死因子受體超家族(Tumor Necrosis Factor Receptor Superfamily 9,TNFRSF9)成員,主要表達於活化的T細胞、NK細胞和樹突狀細胞等腫瘤免疫細胞,CD137的配體CD137L主要表達於活化的APC。T細胞在接受APC遞呈MHC分子複合信號後,4-1BB瞬時表達,當有持續的抗原信號時,4-1BB表達延長,4-1BB經三聚化的4-1BBL誘導發生聚集,招募TRAF1和TRAF2,進而上調抗凋亡基因家族成員,下調促凋亡分子Bim,以及促進絲裂原相關蛋白激酶的信號傳導級聯,從而有效促進CD8+細胞的增殖分化以及減少活化誘導的細胞死亡,維持CD8+T細胞的存活狀態,進而殺死腫瘤細胞發揮抑瘤作用。

目前以CD137(4-1BB)為靶點的藥物均尚未上市,最前沿研發狀態處於臨牀Ⅱ期研究階段,臨牀主要擬用適應症為實體瘤、慢性淋巴細胞白血病、非霍奇金淋巴瘤等。與同靶點藥物相比HOT-1030作為抗CD137(4-1BB)單克隆抗體,能特異性與人4-1BB結合,親和力較高或相當;同時通過對Fc段突變,HOT-1030安全性較高。

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