鍵凱科技(688356.SH):子公司聚乙二醇伊立替康II期臨牀試驗完成首例受試者入組
格隆匯11月15日丨鍵凱科技(688356.SH)公佈,公司的全資子公司天津鍵凱科技有限公司自主研發的聚乙二醇伊立替康(藥物代碼:JK-1201I),目前正在開展的II期臨牀試驗“JK1201I在患者中的安全性、耐受性及初步有效性研究”已於近日完成首例受試者入組。
聚乙二醇伊立替康是子公司自主研發的1類創新藥物,臨牀擬開發適應症為實體瘤,目前尚無此類國產藥物上市。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。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。
在已經完成的I期臨牀試驗“JK1201I用於惡性實體瘤患者的安全性、耐受性和藥代動力學研究”的中,聚乙二醇伊立替康顯示出良好的耐受性和安全性,並對該藥物在多瘤種晚期癌症患者中的療效進行了初步評估。結果顯示,JK-1201I在前期的人體內臨牀試驗中與對照藥相比具有安全性好,毒副作用小,半衰期顯著延長等優點。
近期,子公司展開的II期臨牀試驗“JK1201I在患者中的安全性、耐受性及初步有效性研究”已於近日完成首例受試者入組。
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