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康臣藥業(01681.HK):與上海藥明就研發若干創新藥物訂立戰略合作協議及項目協議

格隆匯7月18日丨康臣藥業(01681.HK)公佈,公司全資附屬公司廣州康臣藥業有限公司(“廣州康臣”)與上海藥明康德新藥開發有限公司(“上海藥明”)(i)於2021年6月27日就研發若干創新藥物的戰略合作訂立一項戰略合作協議;(ii)於2021年6月28日訂立有關用於急性腎損傷一類新藥研發項目的協議(“項目協議-I”); 及(iii)於2021年6月28日訂立有關用於尿毒症瘙癢一類新藥研發項目的協議(“項目協議-II”,與項目協議-I,統稱“項目協議”)。

根據戰略合作協議,廣州康臣及上海藥明擬合作研發主要用於治療腎病及其併發症的創新小分子藥物,並可能隨後擴展至其他疾病領域的其他創新藥物。廣州康臣及上海藥明將定期討論腎病領域新藥研發上的合作機會。雙方本着共同投資、共同開發、共擔風險的原則,相互將對方列為重要戰略合作伙伴。

公吿顯示,項目協議-I為用於急性腎損傷治療一類新藥研發項目,以急性腎損傷作為首選適應症,由上海藥明負責臨牀前的研究開發工作,由廣州康臣向中國國家藥品監督管理局(“NMPA”)遞交臨牀I期試驗申請並獲取臨牀默示許可,及負責後續的臨牀開發和商業化工作。

項目協議-I的臨牀前候選化合物(PCC)的知識產權由廣州康臣及上海藥明雙方共同所有,本項目的臨牀試驗默示許可對應相關的臨牀試驗申辦權和生產批件歸廣州康臣獨家所有。

項目協議-II為用於尿毒症瘙癢治療一類新藥研發項目,以尿毒症瘙癢作為首選適應症,由上海藥明負責臨牀前的研究開發工作,由廣州康臣向NMPA遞交臨牀I期試驗申請並獲取臨牀默示許可,及負責後續的臨牀開發和商業化工作。

項目協議-II的臨牀前候選化合物(PCC)的知識產權由廣州康臣及上海藥明雙方共同所有,本項目的臨牀試驗默示許可對應相關的臨牀試驗申辦權和生產批件歸廣州康臣獨家所有。

集團通過與上海藥明的合作將進一步提高研發能力和創新程度。戰略合作及項目協議項下的合作將充分發揮訂約雙方的長處,通過優勢互補、強強聯合,在新藥研發及產品營銷領域達致雙贏,併為公司發展成為“全方位腎科龍頭”奠定基礎。

董事局認為,戰略合作及項目協議項下的合作將助力公司開發更廣泛及新穎的腎病藥物領域研發管道、進一步提升其於市場上的整體優勢及競爭力,該等合作與公司發展策略一致並符合公司及其股東整體的利益。

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