康哲藥業(00867.HK)：康聯達與君實生物設立合資於東南亞多國合作開發和商業化特瑞普利單抗
格隆匯3月28日丨康哲藥業(00867.HK)公吿，於2023年3月27日，集團通過公司東南亞業務("康聯達")公司Rxilient Biotech Pte.Ltd.("康聯達生技")及Excellmab Pte.Ltd.與上海君實生物醫藥科技股份有限公司("君實生物")訂立股東協議，君實生物將以非貨幣方式出資認購Excellmab新發行的股份以獲得其40%的股權。
受限於股東協議項下約定的先決條件達成，君實生物將實質履行出資義務，並計劃按照訂立股東協議時各方已商定的文本與Excellmab訂立獨佔許可協議，Excellmab將獲得在泰國、文萊、柬埔寨、印度尼西亞、老撾、馬來西亞、緬甸、菲律賓及越南開發和商業化靜脈注射用特瑞普利單抗獨佔許可及其他相關權利(連同訂立股東協議稱為"本次合作")。
根據股東協議，康聯達生技將以500萬美元認購Excellmab新發行的股份，君實生物將以授予Excellmab許可協議中相關權利的方式支付股東協議的認購款項。本次發行完成後，Excellmab將分別由康聯達生技及君實生物擁有60%及40%的權益。
Excellmab將負責在相關區域內對相關產品進行開發、開展醫學事務、成品生產及商業化。Excellmab可供分配的利潤將按照訂約方各自的持股比例進行分配。
根據許可協議，Excellmab將獲得在區域開發和商業化靜脈注射用特瑞普利單抗(包含任何可適用監管機構已批准或未來批准上市的人類腫瘤適應症)的獨佔許可及其他相關權利。Excellmab將向君實生物支付合共最高不超過約452萬美元的里程碑費款項，及產品於區域內淨銷售額一定比例的特許權使用費。
Excellmab也將獲得許可協議約定的另外四款在研產品在區域內的商業化優先談判權。
康聯達聚焦東南亞市場未被滿足的臨牀需求，由專業、經驗豐富的本土化團隊獨立運營，持續與全球生物製藥企業深入合作，快速導入來自歐美、日本和中國的優質產品，搭建合作共贏、互惠互利的東南亞生物醫藥生態圈。
憑藉本次合作，康聯達將中國創新藥出海的重要品種特瑞普利單抗引入東南亞市場，有望實現中國PD-1單抗產品首次在東南亞國家商業化。通過設立合資公司的合作模式，結合康聯達藥物註冊和商業化優勢以及君實生物雄厚的研發實力，實現優勢互補、強強聯合。依託合資公司這一平台，康聯達也計劃與君實生物進行深入合作，將更多優質創新藥引入東南亞市場，實現雙方的共同、長足發展。
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