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長春高新(000661.SZ):子公司GenSci128片臨牀試驗申請獲得批準
格隆匯 04-01 19:50

格隆匯4月1日丨長春高新(000661.SZ)公佈,子公司長春金賽藥業有限責任公司(簡稱“金賽藥業”)收到國家藥品監督管理局覈準簽發的《藥物臨牀試驗批準通知書》,金賽藥業GenSci128片的境內生產藥品註冊臨牀試驗申請獲得批準,TP53是人類癌症中最常發生突變的基因。TP53基因編碼的p53蛋白作爲轉錄因子,具有抑制腫瘤的功能。TP53基因突變導致p53蛋白失活,是腫瘤發生的關鍵步驟。其中,TP53Y220C突變約佔TP53突變的1.8%。臨牀上尚無獲批的靶向TP53Y220C突變的治療手段。對於標準治療失敗的具有TP53Y220C突變的患者,仍存在未被滿足的醫療需求。公司GenSci128片屬治療用化藥1類新藥,是針對TP53Y220C突變的選擇性重激活劑,旨在選擇性地與TP53Y220C突變蛋白的口袋結合,從而恢復TP53Y220C突變蛋白的正常構象,增加穩定性,恢復轉錄和抑制腫瘤的功能。臨牀前數據表明GenSci128片具有較好的療效和安全性。

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