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綠葉製藥(02186.HK):地舒單抗注射液(LY01011)啟動臨牀III期試驗
格隆匯 12-15 22:04

格隆匯 12 月 15日丨綠葉製藥(02186.HK))宣佈,集團子公司山東博安生物技術有限公司("博安生物")產品地舒單抗注射液(LY 01011)於中國啟動臨牀比對試驗(III期)。

LY 01011為地舒單抗注射液(Xgeva®生物類似藥),用於預防多發性骨髓瘤和實體瘤骨轉移患者骨相關事件;用於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;及用於治療雙膦酸鹽難治性惡性腫瘤引發的高鈣血癥(HCM)。

根據公開的財務報告,Xgeva®於2019年的全球銷售額為19.4億美元,同比增長率為8.3%,並於2019年5月獲得中國上市批准。集團的地舒單抗注射液亦已在美國和歐洲開始臨牀試驗。

除地舒單抗注射液外,博安生物憑藉高效創新的內部能力已開發出10餘個擁有國際知識產權保護的創新抗體和8個生物類似藥。生物類似藥方面,LY 01008(Avastin之生物類似藥)已申報中國上市申請;LY 06006(Prolia之生物類似藥)處於中國III期臨牀及歐美I期臨牀;LY 09004(Eylea之生物類似藥)處於中國III期臨牀。此外,一個創新抗體項目已進入中國I期臨牀。

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