百濟神州(06160.HK)宣佈與諾華在北美、歐洲和日本開發和商業化抗PD-1抗體百澤安®達成的合作正式生效
格隆匯 3 月 1日丨百濟神州(06160.HK)發佈公吿，百濟神州於2021年2月26日(美國東部時間)宣佈，與諾華於2021年1月11日達成的合作與授權協定正式生效，將在美國、加拿大、墨西哥、歐盟成員國、英國、挪威、瑞士、冰島、列支敦斯登、俄羅斯和日本開發、生產和商業化抗PD-1抗體百澤安® (替雷利珠單抗)。雙方已同意在上述國家對百澤安®進行共同開發，其中諾華將在過渡期後負責註冊申請，並在獲得批准後開展商業化活動。此外，雙方均可在全球範圍內開展臨牀試驗以評估百澤安®聯合其他抗腫瘤療法的潛在用藥組合；百濟神州可在北美地區共同進行產品銷售，其中部分運營資金將由諾華提供。
百濟神州聯合創始人、董事長兼首席執行官歐雷強先生(John V. Oyler)表示：“自與諾華宣佈合作以來，我們兩家公司一直在積極籌備相關執行工作，希望能將百澤安®帶給世界各地更多的患者，無論是通過諾華在授權地區或是百濟神州在全球其他地區對百澤安®進行商業化，還是雙方將百澤安®與自主研發或第三方藥物聯合開展臨牀試驗。在與諾華宣佈合作後的短短一個多月中，百澤安®更是接二連三達到新的里程碑事件，先是一項用於治療既往接受過治療的晚期不可切除或轉移性食管鱗狀細胞癌患者的全球3期臨牀試驗獲得積極主要結果，後又在中國獲批聯合化療用於治療一線晚期鱗狀非小細胞肺癌患者。我們很高興與諾華達成合作，以進一步實現這款潛在差異化的抗PD-1抗體在全球範圍內的發展機遇。”
根據合作與授權協定，百濟神州將獲得6.5億美元的預付款，並有資格在達到註冊里程碑事件後獲得至多13億美元的付款、在達到銷售里程碑事件後獲得2.5億美元的付款，另有資格獲得百澤安®在授權地區未來銷售的特許使用費。根據協定，百濟神州將負責為正在開展的百澤安®臨牀試驗提供資金，諾華將在授權地區為新開展的註冊性、橋接或藥品上市後的研究提供資金，每一方將負責為各自用於評估百澤安®聯合該方或第三方藥物開展的臨牀試驗提供資金。雙方將保留其自主開發產品聯合百澤安®用藥組合的全球商業化權利。
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