君實生物(688180.SH):第四代EGFR抑制劑WJ13404片的臨牀試驗申請獲受理
格隆匯4月1日丨君實生物(688180.SH)公佈,近日,公司控股子公司蘇州君境生物醫藥科技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》,第四代EGFR抑制劑WJ13404片(項目代號“JS113”)的臨牀試驗申請獲得受理。
JS113是一種原創(first-in-class)的第四代EGFR(表皮生長因子受體)抑制劑,由公司與微境生物醫藥科技(上海)有限公司合作開發,擬用於EGFR突變非小細胞肺癌和其他實體瘤的治療。JS113具有全新的分子骨架和獨特的生物活性,臨牀前數據顯示該藥物分子對第三代EGFR抑制劑不敏感的原發性和獲得性EGFR突變(包括Del19/T790M/C797S和L858R/T790M/C797S共突變),以及部分TKI耐藥的旁路激活靶點和免疫抑制性靶點都有很好的抑制活性,同時對野生型EGFR具有高度選擇性。
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