三生製藥(01530.HK)抗IL-5單克隆抗體獲臨牀試驗批准
格隆匯2月25日丨三生製藥(01530.HK)發佈公告,集團的重組抗白細胞介素-5(Interleukin-5,IL-5)人源化單克隆抗體注射液(“610”)的臨牀試驗申請於2020年2月25日獲得國家藥品監督管理局批准,用於重度嗜酸性粒細胞性哮喘維持治療的附加治療,集團正積極準備開展該產品的臨牀試驗。
根據披露,610是一種人源化單克隆抗體,特異靶向白細胞介素-5。IL-5是一種主要在特應性疾病中起致病作用的細胞因子,能夠調節嗜酸性粒細胞的生長、活化、存活,並能夠為嗜酸性粒細胞從骨髓遷移至肺部及其他器官提供重要信號。嗜酸性粒細胞被認為在眾多由炎症引發的疾病中起到關鍵的作用,其中包括哮喘。研究表明相比標準治療方法,減少呼吸道嗜酸性粒細胞增多能夠有效改善哮喘症狀和減少急性加重發作的次數。610與IL-5結合,阻斷IL-5與嗜酸性粒細胞表面IL-5受體的結合,從而抑制其生物學活性,降低血液、組織、痰液中的嗜酸性粒細胞水準,達到減輕嗜酸性粒細胞所介導的炎症反應的治療效果。
隨着單克隆抗體技術的發展,靶向IL-5已成為治療難治性嗜酸性粒細胞哮喘的重要方法,主要用於經糖皮質激素和長效支氣管擴張劑聯合治療後症狀仍未控制的嚴重哮喘患者。
該公司主席兼行政總裁婁競博士評論道:“我們很高興看到抗IL-5單克隆抗體的新藥臨牀申請獲國家藥品監督管理局批准。同時期望於中國加速推進該產品的臨牀試驗進程。三生製藥將繼續尋找機會,致力於探尋及開發更安全有效的治療性生物製劑,以應對迫切的醫療需求,為自身免疫類疾病患者提供重要的治療選擇。”
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