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鍵凱科技(688356.SH):子公司聚乙二醇伊立替康新適應症獲批開展II期臨牀試驗
格隆匯 04-15 15:41

格隆匯4月15日丨鍵凱科技(688356.SH)公佈,近日,北京鍵凱科技股份有限公司子公司天津鍵凱科技有限公司自主研發的注射用聚乙二醇伊立替康(藥物代碼:JK-1201I)聯合替莫唑胺用於腦膠質瘤治療的臨牀研究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》,將於近期啓動國內Ⅱ期臨牀試驗。

聚乙二醇伊立替康是公司自主研發的小分子長效抗癌1類創新藥物,該藥物是將伊立替康以聚乙二醇進行修飾後得到的新型化學藥品。目前注射用聚乙二醇伊立替康治療實體瘤適應症正在進行II臨牀試驗。

本次藥品申報擬開展適應症爲腦膠質瘤的臨牀試驗。已開展的非臨牀研究的實驗結果表明,JK-1201I具有顯著、廣譜的抗腫瘤活性,藥效優於同樣給藥方案的鹽酸伊立替康,毒性低於鹽酸伊立替康。該項目於2022年2月獲得國家藥監局正式受理。近日,該項目獲得了國家藥監局覈準簽發的《藥物臨牀試驗批準通知書》,同意按照已提交的方案開展新藥臨牀試驗。

截至公告日,全球未有同類型同適應症的藥品上市。

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