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開拓藥業-B(09939.HK)與復星醫藥就普克魯胺治療新冠在印度和非洲商業化達成合作

格隆匯7月15日丨開拓藥業-B(09939.HK)發佈公吿,2021年7月14日,公司全資附屬公司蘇州開拓藥業股份有限公司與復星醫藥(600196.SH/02196.HK)的全資附屬公司復星醫藥產業就普克魯胺治療新冠在印度和28個非洲國家治療新冠適應症的商業化達成普克魯胺項目許可協議書,雙方同意相互合作、共同推進普克魯胺治療新冠適應症的緊急使用授權(EUA)申請、推廣和銷售工作。

根據許可協議,復星醫藥產業將獲得普克魯胺在合作區域的獨家註冊和商業化銷售權益。同時,開拓藥業有權收取總金額不超過人民幣5.6億元的首付款及里程碑付款(首付款和開發里程碑付款約人民幣1.1億元及商業化里程碑付款不超過人民幣4.5億元)。此外,開拓藥業有權按雙方約定的基於淨銷售額的分級收取合作區域內不低於50%的利潤總額作為提成。

根據披露,普克魯胺是新一代雄激素受體拮抗劑。自2020年初新冠疫情大流行以來,開拓藥業普克魯胺在用於潛在新冠治療的研究上取得迅速進展。2021年,開拓藥業取得美國食品藥品監督管理局(FDA)及巴西國家衞生監督局(ANVISA)同意或批准,以開展普克魯胺用於治療新冠患者的III期臨牀試驗。該集團正在全球開展普克魯胺用於治療非住院新冠患者的兩項註冊性III期臨牀試驗(全球多中心)和一項用於治療住院新冠患者的註冊性III期臨牀試驗(全球多中心),包括美國、南美洲(含巴西)、歐盟、亞洲等國家和地區。

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