三生國健(688336.SH):重組抗IL-5人源化單克隆抗體注射液(610)Ib期臨牀試驗完成首例受試者入組
格隆匯12月14日丨三生國健(688336.SH)公佈,公司自主研發的抗白介素5(IL-5)的人源化單克隆抗體藥物(研發代號:610)在嗜酸性粒細胞增高的哮喘患者中開展的一項“評價重組抗IL-5人源化單克隆抗體注射液(610)在嗜酸性粒細胞增高的哮喘受試者中多次給藥的隨機、雙盲、安慰劑平行對照的安全性、耐受性、藥代動力學特徵和初步療效的臨牀研究”,於近日完成首例受試者入組。
610產品是公司自主研發設計、篩選並人源化的抗IL-5單克隆抗體,具有全新的氨基酸序列。610能夠通過特異性的結合IL-5,阻斷IL-5與其受體結合,進而發揮抑制IL-5生物學活性的作用,從而有效地抑制氣道嗜酸粒細胞性炎症反應,降低哮喘急性加重的風險。
全球範圍內針對IL-5靶點治療嗜酸性粒細胞增高哮喘的上市藥物有葛蘭素史克的Nucala®(美泊利珠單抗)、梯瓦製藥的Cinqair®(瑞替珠單抗)、阿斯利康的Fasenra®,我國目前尚未有針對IL-5靶點治療嗜酸性粒細胞增高的哮喘的藥物獲批。早期研發數據顯示,610製劑與已上市藥物Mepolizumab和Reslizumab在靶點、有效性、安全性等方面有一定的相似性,在對嗜酸性粒細胞性哮喘治療方面具有較大的潛力。
目前公司在嗜酸性粒細胞增高的哮喘患者中開展的一項“評價重組抗IL-5人源化單克隆抗體注射液(610)在嗜酸性粒細胞增高的哮喘受試者中多次給藥的隨機、雙盲、安慰劑平行對照的安全性、耐受性、藥代動力學特徵和初步療效的臨牀研究”,於近日成功完成首例受試者入組。在此前已完成的健康成年志願者單次給藥、劑量遞增的Ia期臨牀試驗中,研究結果顯示:610顯示出良好的耐受性和安全性;整體PK特徵與美泊利珠單抗比較類似,無ADA發生。
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