長春高新(000661.SZ):子公司GenSci128片新藥臨牀試驗申請獲得FDA批准
格隆匯5月28日丨長春高新(000661.SZ)公佈,近日,長春高新技術產業(集團)股份有限公司子公司——長春金賽藥業有限責任公司(以下簡稱“金賽藥業”)收到美國食品藥品監督管理局(以下簡稱“FDA”)關於同意GenSci128片開展臨牀試驗的批准。
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TP53 Y220C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。GenSci128片在美國新藥註冊類別“505b1”,擬用於治療攜帶TP53 Y220C突變的局部晚期或轉移性實體瘤,其新藥臨牀試驗申請已獲得FDA批准。金賽藥業將按照FDA相關要求和法律法規,有序開展相關後續多中心臨牀試驗工作。
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