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基石藥業-B(02616.HK)與歐洲百年藥企Gentili就舒格利單抗在西歐和英國達成獨家戰略合作
格隆匯 07-08 08:09

格隆匯7月8日丨基石藥業-B(02616.HK)發佈公告,基石藥業與一家專注腫瘤領域,並在歐洲市場深耕百年的生物醫藥公司Istituto Gentili(“Gentili”)就舒格利單抗在西歐和英國的商業化達成獨家戰略合作。根據協議條款,Gentili將獲得舒格利單抗在包括十八個EEA國家(奧地利、比利時、塞浦路斯、丹麥、芬蘭、法國、德國、希臘、愛爾蘭、義大利、列支敦士登、盧森堡、馬爾他、荷蘭、挪威、葡萄牙、西班牙及瑞典),以及英國、安道爾、摩納哥、聖馬利諾及梵蒂岡在內的二十三個國家的獨家商業化權利。

基石藥業將從Gentili獲得首付款、註冊及銷售里程碑付款,交易總金額最高可達1.925億美元。此外,通過向Gentili供應舒格利單抗,公司還將獲得授權區域內舒格利單抗近50%淨銷售額的營收分成。Gentili將負責舒格利單抗在上述地區的註冊及商業化相關活動。

基石藥業首席執行官、研發總裁、執行董事楊建新博士表示:“舒格利單抗是首個在歐盟及英國獲批聯合化療一線治療IV期非小細胞肺癌全人羣(不限組織學分型及PD-L1表達水平)的PD-L1單抗,其針對III期NSCLC的新適應症申請也已獲歐洲藥品管理局(EMA)受理,若順利獲批,舒格利單抗將成爲歐洲第二款治療該適應症的PD-(L)1抗體。

Gentili憑藉深厚的腫瘤學專業積澱、成熟的商業化體系及以患者爲中心的創新理念,成爲加速舒格利單抗在歐洲市場可及性的理想合作夥伴。尤其當前以美國市場定價爲基準的免疫治療藥物,由於受到美國藥品定價體系改革爭議影響,其全球供應與支付模式正面臨新的變數。在此背景下,擴大舒格利單抗這類具有重大臨牀價值療法的可及性,已成爲全球醫療界的當務之急。

迄今我們已在歐洲、中東及非洲、拉丁美洲就舒格利單抗達成四大區域性合作,累計覆蓋六十餘個國家和地區。舒格利單抗的海外上市即將全面啓動,我們將通過深度整合夥伴優勢資源,加速全球佈局和商業化落地,全面釋放舒格利單抗的臨牀價值和市場潛力。與此同時,我們也在積極推動東南亞、加拿大等地區的合作洽談,並持續拓展舒格利單抗其他適應症的註冊申報。”

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