賽升藥業(300485.SZ)與北京大學葉藴華教授簽署GGE-3技術合作協議
格隆匯 8 月 19日丨賽升藥業(300485.SZ)公佈,公司(“甲方”)與北京大學葉藴華教授(“乙方”)簽署了技術合作協議。本着把科研成果轉化為治療疾病藥物產品為目的,賽升藥業與葉藴華教授約定共同完成GGE-3對腦卒中或腦外傷引起的神經系統病症以及輕、中度阿爾茨海默症等疾病的藥效學、作用機制、安全性、藥代動力學及相關藥學和毒理學研究,進行申報並獲得相應臨牀和生產批准文件,使產品上市,或開發成其他產品形式上市。
GGE-3具有自主知識產權(專利號CN101747226)的新分子實體。GGE-3分子量小(232Da),化學性質十分穩定,既可溶於水又可溶於有機溶劑。從初步研究結果看,GGE-3是一個具有中樞神經系統生物活性的化合物,可能發展為治療神經系統等方面疾病的新藥。雙方本着集成有利資源,把科研成果轉化為治療疾病藥物產品為目的,決定合作開發GGE-3。
GGE-3開發過程分為三個階段,第一階段為GGE-3成藥性評價,對GGE-3的適用症、藥效及安全性開展研究並做出判斷,決定是否進入第二階段。第二階段為臨牀前開發階段,按照國家藥品註冊管理辦法,完成臨牀申請並獲得臨牀批件。第三階段為上市及銷售階段,開展相關臨牀試驗,並按照國家藥品註冊管理辦法,完成上市申請並獲得生產批件,上市銷售。
雙方將利用各方在生物技術、藥物研發、產業政策、金融資本等方面的優勢,此次合作有利於公司新藥研發的創新,是綜合考慮了公司整體經營發展規劃和經營現狀而做出的謹慎決策,符合公司的整體發展戰略。此次技術開發合作不會對公司近期財務狀況和經營狀況產生重大影響,不存在損害上市公司及股東利益的情形。
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