國內首個3.3類Opdivo®生物類似藥臨牀申請獲得受理
綠葉製藥集團(02186.HK)宣佈，旗下子公司博安生物開發的納武利尤單抗注射液(LY01015)的臨牀試驗申請，已獲得國家藥品監督管理局藥品審評中心受理。
LY01015為首個按照治療用生物製品3.3類註冊分類申報的Opdivo®(歐狄沃®)的生物類似藥，用於治療黑色素瘤、非小細胞肺癌、惡性胸膜間皮瘤、腎細胞癌、典型霍奇金淋巴瘤、頭頸部鱗狀細胞癌、尿路上皮癌、結直腸癌、肝細胞癌、食管鱗狀細胞癌以及胃或胃食管連接部腺癌的患者。
以PD-1抑制劑為代表的腫瘤免疫療法已成為中國乃至全球範圍內腫瘤治療的主要手段之一。相較於傳統治療方法，PD-1抑制劑通過激活人體自身的免疫系統來對抗腫瘤細胞——阻斷腫瘤細胞誘導人體免疫細胞T細胞“休眠”的通路，從而部分恢復T細胞殺傷腫瘤細胞的功能，達到長期控制或消除腫瘤的效果，為癌症的治癒帶來希望。
作為全球首個獲得監管機構批准的PD-1免疫檢查點抑制劑，納武利尤單抗注射液已成為治療多種腫瘤的重要選擇，並已在全球獲批十多項適應症。公開財務報吿顯示：LY01015的市場可比產品Opdivo®的2019年全球銷售額達到72億美元，同比增長率為7.0%。業內預計：PD-1抑制劑藥物將在全球抗腫瘤市場規模的增長中持續扮演重要角色；鑑於國內龐大的腫瘤患者數量，且PD-1抑制劑藥物在適應症上的覆蓋相對廣泛，該類產品將在國內和國際市場繼續保持快速放量。
“我們看好LY01015的市場前景，並計劃在中國市場以外的全球其他國家和地區開展該藥物的註冊工作，”博安生物首席執行官姜華表示：“公司正在密集推進研發管線中各候選藥物的研發進程，期待通過提供高品質、可負擔的生物抗體產品，造福中國乃至全球更多有需要的患者。”
作為集團發展的業務重心之一，綠葉製藥正在持續加大對於生物藥的研發投入，通過博安生物加速推動生物藥的全球佈局。目前，博安生物已構建了10多個擁有國際知識產權保護的創新抗體以及8個生物類似藥的產品組合，並在細胞治療等前沿技術領域積極佈局。
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