綠葉製藥(02186.HK)地舒單抗注射液LY01011在華進入Ⅲ期臨牀，歐美臨牀進展順利
綠葉製藥集團宣佈，旗下子公司山東博安生物技術有限公司(博安生物)開發的Xgeva®的生物類似藥--地舒單抗注射液(LY01011)已在中國進入臨牀比對試驗(Ⅲ期臨牀)。該藥物在歐洲和美國開展的臨牀試驗也在順利進行中。
地舒單抗注射液(LY01011)是 Xgeva®(中文商品名：安加維®)的生物類似藥，獲批上市後將用於預防多發性骨髓瘤和實體瘤骨轉移患者骨相關事件；治療不可手術切除或者手術切除可能導致嚴重功能障礙的骨鉅細胞瘤，包括成人和骨骼發育成熟的青少年患者；以及治療雙膦酸鹽難治性惡性腫瘤引發的高鈣血癥(HCM)。
LY01011的市場前景廣闊，需求潛力大。Xgeva®於2010年11月獲得美國食品藥品監督管理局(FDA)批准上市，2011年7月獲得歐洲藥品管理局(EMA)批准上市，2019年5月獲得中國國家藥品監督管理局(NMPA)的批准進口。公開財務數據顯示：Xgeva®在2019年的全球銷售額達到19.4億美元，同比增長8.3%。
博安生物憑藉高效協同的創新能力，目前已開發出十多個擁有國際知識產權保護的創新抗體，其中某創新抗體項目正在中國開展Ⅰ期臨牀研究。在生物類似藥方面，除了LY01011以外，LY01008(Avastin®的生物類似藥)的上市申請已於2020年4月獲得中國藥品審評中心的受理，LY06006(Prolia®的生物類似藥)在中國進入臨牀比對試驗並在歐美進入Ⅰ期臨牀，LY09004(Eylea®的生物類似藥)也已在中國進入臨牀比對試驗階段。
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進生物藥的全球佈局，希望儘快將優質創新產品推向中國及全球市場。目前，博安生物已建立起一系列處於不同階段的創新抗體和生物類似藥產品管線，同時在抗體生物藥領域發展成為具備研發、規模化生產、商業化的完整產業鏈的生物製藥公司。
綠葉製藥集團管理層表示："公司正在積極進行技術轉型升級，進一步加大投入、拓寬生物藥產品組合，並加速推進管線中各產品的上市進度。我們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。"
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