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綠葉製藥(02186.HK):國家藥監局受理LY01015臨牀試驗申請
格隆匯 02-25 22:34

格隆匯2月25日丨綠葉製藥(02186.HK)公佈,公司附屬公司山東博安生物技術有限公司的納武利尤單抗注射液(LY01015)臨牀試驗申請,已獲中國國家藥品監督管理局藥品審評中心(CDE)正式受理。

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,適用於治療黑色素瘤、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。

PD-1是免疫負性調控分子,與其配體PD-L1或PD-L2作用,可下調T細胞活性,導致腫瘤細胞逃逸免疫系統的識別和殺傷。納武利尤單抗是一種人免疫球蛋白G4(IgG4)單克隆抗體,其結合PD-1受體並阻斷它與PD-L1和PD-L2相互作用,通過T細胞介導的免疫應答而發揮抗腫瘤作用。

根據公開的財務報吿,OPDIVO(LY01015的市場可比產品)於2019年的全球銷售額為72.0億美元,同比年增長率為7.0%。OPDIVO於2018年6月獲得中國上市批准。除中國市場外,博安生物還將在全球其他國家和地區開展LY01015的註冊工作。

集團將持續加大對於生物製藥領域的研發投入,以加快推進創新型生物製品的開發,為全球患者提供更好的治療方案和藥品可及性。

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