君實生物(688180.SH):JS010注射液的臨牀試驗申請獲得受理
格隆匯12月30日丨君實生物(688180.SH)公佈,近日,上海君實生物醫藥科技股份有限公司收到國家藥品監督管理局核准簽發的《受理通知書》,JS010注射液(項目代號“JS010”)的臨牀試驗申請獲得受理。
JS010為公司自主研發的重組人源化抗CGRP單克隆抗體注射液,主要用於成人偏頭痛的預防性治療。CGRP是由37個氨基酸組成的神經肽,在哺乳動物的中樞和外周神經系統中表達,其通常分為兩個亞型:α-CGRP和β-CGRP。CGRP多肽水平在偏頭痛發作期間內增加,可以通過CGRP拮抗劑治療加以改善偏頭痛症狀。
臨牀前研究結果表明,JS010能以高親和力結合人α-CGRP和β-CGRP蛋白,且基於報吿基因系統的細胞生物學活性研究表明,JS010能夠有效結合αCGRP或β-CGRP多肽,阻斷其與受體結合,從而抑制細胞內cAMP信號通路,進而發揮預防偏頭痛的作用。臨牀前體內藥效數據顯示,JS010具有顯著的抑制血管擴張效果。此外,動物對JS010的耐受性良好,研究期間所有動物未見顯著異常。截至公吿披露日,全球共有7個靶向CGRP的產品獲批上市,國內尚無同類靶點產品獲批上市。
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