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山東新華製藥股份(00719.HK):與中南大學簽訂"抗肺動脈高壓創新藥物LXH-1211研發"的《技術轉讓合同》
格隆匯 12-21 17:00

格隆匯 12 月 21日丨山東新華製藥股份(00719.HK)公佈,公司於2020年12月21日與中南大學簽訂了"抗肺動脈高壓創新藥物LXH-1211研發"的《技術轉讓合同》。

按照中國《藥品註冊管理辦法》的要求,在中國國內開發1類創新藥——抗肺動脈高壓創新藥物LXH-12119(最終名稱以國家藥品監督管理局(NMPA)批准的新藥名稱為準),確保臨牀試驗批件申請的順利申報。

合同簽訂後,中南大學將合同簽訂前全部研究資料副本提供給新華製藥,包含已完成的肺動脈高壓候選藥物的發現、設計、合成路線的技術資料及相關藥效學評價的總結資料。中南大學將提供必要的技術支持和指導,直到藥品上市。

公告稱,合同簽訂後該專利的所有費用由公司支付,在支付完合同約定款後,新華製藥將成為"LXH-1211"創新藥物中國相關專利的專利權人,但國際專利的申請除外。該項目相關在中國市場的所有知識產權全部歸公司獨有,由此產生的其他知識產權也全部歸公司獨有。"LXH-1211"若取得生產批文,則歸新華製藥所有。

根據合同約定,公司支付給中南大學研究開發經費和報酬總額為人民幣叁仟萬元整。按照合同約定分期支付給中南大學。產品上市後,公司按照該產品年度銷售收入的2%向中南大學支付提成費用,從公司正式生產之日起,10年為最低提成年限,如果專利保護期超過該藥上市後10年,則以專利到期日為準。

公司與中南大學此次項目合作是首次合作。中南大學在抗肺動脈高壓創新藥物領域的研究水平處於國內領先地位。中南大學在抗肺動脈高壓創新藥物領域研究多年,積累了豐富經驗,基礎研究紮實,已經基本完成了新藥發現階段的研究,開發風險大大降低。新華製藥與中南大學合作,旨在為公司在肺動脈高壓治療領域開創全新新藥。

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