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復宏漢霖(02696.HK):HLX51用於晚期/轉移性實體瘤和淋巴瘤治療的臨牀試驗申請獲國藥監局批准
格隆匯 03-15 18:02

格隆匯3月15日丨復宏漢霖(02696.HK)宣佈,近日,公司自主研發的HLX51(注射用重組抗OX40人源化單克隆抗體)("HLX51")用於晚期/轉移性實體瘤和淋巴瘤治療的臨牀試驗申請獲國家藥品監督管理局批准。

公司擬於條件具備後於中國大陸境內開展1期臨牀試驗。HLX51為公司自主研發的抗OX40激動型人源化單克隆抗體,計劃用於實體瘤和淋巴瘤治療。OX40(腫瘤壞死因子受體超家族成員4,又稱TNFRSF4、CD134)是T細胞的共刺激分子,主要在活化的T細胞上表達。OX40與其配體OX40L結合可釋放共刺激信號,抑制活化誘導的細胞死亡(activation inducedcell death,AICD),並促進抗原特異性記憶T細胞的存活。HLX51通過與OX40L競爭性結合OX40,可代替OX40L刺激OX40且不降低OX40刺激信號,從而刺激T細胞增殖及活化,進而增強T細胞的殺傷能力;此外,還可以抑制調節性T細胞(「Treg」)的增殖及激活,解除Treg細胞介導的免疫抑制功能,改善腫瘤微環境中的免疫抑制作用,進一步促進T細胞釋放細胞因子,從而發揮更強的抗腫瘤作用。臨牀前研究結果顯示,HLX51可顯着抑制腫瘤生長,具有良好的耐受性和安全性。

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