三生國健(688336.SH):重組抗IL-1β人源化單抗I期臨牀試驗完成首例受試者入組
格隆匯8月19日丨三生國健(688336.SH)宣佈,公司研發的重組抗IL-1β人源化單克隆抗體注射液(藥物代碼:SSGJ-613)目前進行的一項“評價重組抗IL-1β人源化單克隆抗體注射液(SSGJ-613)在健康受試者中單次皮下注射的隨機、雙盲、安慰劑平行對照的安全性、耐受性及藥代動力學特徵的I期臨牀研究”已於近日成功完成首例受試者入組。
重組抗IL-1β人源化單克隆抗體注射液是一個具有全新的可變區序列的抗IL-1β抗體。實驗結果表明SSGJ-613與目前已上市的同靶點產品Canakinumab具有完全不同的結合表位。SSGJ-613能夠特異性地與IL-1β結合,有效阻斷IL-1β介導的信號傳導,抑制其產生的炎症效應,具有治療多種自身免疫性炎症疾病的潛力。
目前FDA和EMA共批准三種IL-1拮抗劑藥物,分別為Anakinra(Sobi公司,IL-1受體拮抗劑,可阻斷IL-1β和IL-1α);Rilonacept(再生元,可溶性IL-1受體融合蛋白,可中和IL-1β和IL-1α);Canakinumab(諾華,靶向抑制IL-1β的唯一的全人源化單克隆抗體),2020年Canakinumab銷售金額達到8.7億美金。以上三種製劑均未在國內上市。
目前國內尚無自主研發的針對IL-1β的單克隆抗體上市,考慮到我國人口基數大及此類藥物在多種炎症性疾病的潛在應用,新型的針對IL-1β的單克隆抗體是目前臨牀中未被滿足的用藥需求。
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