復宏漢霖(02696.HK)抗死亡受體4(DR4)單抗注射液HLX56臨試申請獲批准
格隆匯5月8日丨復宏漢霖-B(02696.HK)發佈公告,近日,公司研製的抗死亡受體4(Death Receptor 4,“DR4”)單抗注射液HLX56(“HLX56”)用於治療無其他標準治療晚期實體瘤的臨牀試驗申請獲台灣衞生福利部批准。
HLX56是公司自Galaxy Biotech,LLC授權引進,並後續自主研發的一種人源化、具有κ輕鏈的抗死亡受體4(DR4)胞外域的IgG1型單克隆抗體,為創新型治療用單克隆抗體,擬用於晚期實體瘤治療。DR4屬腫瘤壞死因子受體超家族成員,其胞質區含死亡結構域,分佈於腫瘤細胞、淋巴組織和活化的 T細胞。HLX56的主要作用機制為單核細胞表面的FcγRIIb與HLX56抗體結合後,其交聯作用導致抗體Fab段與腫瘤細胞表面的DR4發生多聚化,從而增強促凋亡信號,引起腫瘤細胞的凋亡。臨牀前藥理學研究、藥代動力學研究及安全性評價的研究結果表明,HLX56在體內、外實驗中均表現出顯着的腫瘤抑制活性及良好的安全性。
截至該公告日,於全球範圍內尚無靶向DR4的單克隆抗體藥品上市。
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