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君實生物(01877.HK):注射用JS212獲得藥物臨牀試驗申請受理通知書
格隆匯 01-08 18:35

格隆匯1月8日丨君實生物(01877.HK)公吿,近日,上海君實生物醫藥科技股份有限公司(以下簡稱“公司”)收到國家藥品監督管理局核准簽發的《受理通知書》,注射用JS212(項目代號“JS212”)的臨牀試驗申請獲得受理。由於藥品的研發週期長、審批環節多,容易受到一些不確定性因素的影響,本次臨牀試驗申請能否獲得批准存在不確定性,敬請廣大投資者謹慎決策,注意防範投資風險。

JS212是重組人源化抗表皮生長因子受體(以下簡稱“EGFR”)和人表皮生長因子受體3(以下簡稱“HER3”)雙特異性抗體偶聯藥物(以下簡稱“ADC”),主要用於晚期惡性實體瘤的治療。EGFR和HER3在多種腫瘤細胞表面存在高表達,如肺癌、乳腺癌、頭頸部腫瘤等。EGFR和HER3間存在信號通路的相互作用,共同參與促進腫瘤細胞的增殖、存活、遷移和血管生成等過程,HER3高表達為腫瘤組織發生EGFR耐藥的重要機制之一。與單一靶點ADC藥物相比,JS212能夠通過與EGFR或HER3結合發揮腫瘤抑制作用,有望對更廣泛的腫瘤有效,同時有望克服耐藥性問題。臨牀前研究顯示,JS212與EGFR和HER3的高親和力、特異性結合作用,在多個動物模型中展示了顯著的抑瘤作用。同時,JS212具備良好、可接受的安全性。

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