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基石藥業-B(02616.HK):國產PD-L1出海重大里程碑!歐盟人用藥品委員會推薦批准Cejemly®(舒格利單抗)用於一線治療非小細胞肺癌
格隆匯 06-03 08:06

格隆匯6月3日丨基石藥業-B(02616.HK)發佈公吿,歐洲藥品管理局(EMA)人用藥品委員會(CHMP)已發佈其推薦批准舒格利單抗聯合化療用於轉移性非小細胞肺癌(NSCLC)患者的一線治療的正面意見。NSCLC是全球最高發的癌症之一,也是導致死亡的最主要癌種之一。舒格利單抗有望成為全球首個將在歐洲上市、不論PD-L1表達水平、且同時覆蓋一線鱗狀和非鱗狀NSCLC的PD-L1單抗,基石藥業亦有望成為首家將國產PD-L1單抗成功推向國際市場的創新生物醫藥企業。

基石藥業首席執行官、研發總裁兼執行董事楊建新博士表示,“CHMP的正面意見一般標誌着我們即將迎來歐盟委員會的正式上市批准,這無論是對於舒格利單抗這款藥物、還是對於基石藥業本身,甚至對於整個中國創新藥行業來説都是一個振奮人心的重要里程碑!這不僅意味着我們離為歐洲肺癌患者提供這一創新療法更近了一步,更彰顯了基石藥業在國際化戰略上的重大突破。IV期NSCLC是舒格利單抗多個適應症中首個被證實能顯着獲益的適應症,我們也計劃為其他適應症提交註冊申請,包括III期NSCLC,胃癌,食管癌等。此外,繼近期與Ewopharma在18箇中歐/東歐國家與瑞士達成舒格利單抗的戰略商業化合作之後,我們陸續又與多個其他國家和地區的潛在合作伙伴進行深入洽談。我們滿懷信心,期待共同攜手將這一創新藥迅速推向更廣闊的全球市場,讓更多患者受益。同時,我也想借此機會感謝基石團隊多年來為實現這一重要里程碑所付出的辛勤努力和堅持。”

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