康泰生物(300601.SZ):將獨家獲得阿斯利康腺病毒載體新冠疫苗的國內開發、生產及商業化的授權許可
格隆匯 8 月 6日丨康泰生物(300601.SZ)公佈,公司與AstraZeneca UK Limited(“阿斯利康”)簽署了《約束性交易條款清單》。
阿斯利康與牛津大學在全球開發、生產和供應ChAdOx1腺病毒載體新冠疫苗(“AZD1222”或“許可產品”)。近期在頂級醫學期刊《柳葉刀》上公佈的I期/II期COV001臨牀試驗的中期結果顯示,在所有接受評估的受試者中,該疫苗可以耐受併產生針對SARS-CoV-2病毒的穩健的免疫應答。目前,該疫苗的II期/III期臨牀試驗正在全球多個國家進行。
阿斯利康獨家授權公司在中華人民共和國(不包括香港特別行政區、澳門特別行政區、台灣地區)(“區域”)內對許可產品進行研發、生產及商業化。未經阿斯利康事先書面同意,公司不得將其在本條款清單項下獲得的任何權利進一步授予分許可。
公司擁有在區域內開發許可產品的唯一權利,負責在區域進行監管批准所需的臨牀試驗,負責與監管機構的所有溝通。所有註冊相關申請文件均應以公司的名義遞交並由公司擁有,公司應盡最大努力完成許可產品的開發,取得註冊批準,並進行商業化。在其他區域對許可產品的供應、臨牀開發、註冊和商業化由雙方另行協商決定。
公司確保在2020年年底前能夠擁有至少每年生產1億劑的充足產能,並在2021年年底前擁有至少每年生產2億劑的產能。
公司將按照約定向阿斯利康支付許可費,如因任何原因導致公司無法按時向阿斯利康支付前述費用,則基於阿斯利康的選擇,公司應向阿斯利康投資(中國)有限公司支付前述費用。
此次公司與阿斯利康簽署《約束性交易條款清單》,公司將獨家獲得其腺病毒載體新冠疫苗的開發、生產及商業化的授權許可,有利於豐富公司的疫苗研發技術、增強公司的疫苗研發實力。
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