綠葉製藥(02186.HK):LY 06006在中國完成III期臨牀所有受試者末次給藥
格隆匯 1 月 25日丨綠葉製藥(02186.HK)發佈公吿,集團附屬公司山東博安生物技術有限公司(“山東博安”)的重組抗RANKL全人單克隆抗體注射液(地舒單抗注射液,LY 06006)已於中國完成III期臨牀所有受試者末次給藥。
LY 06006為重組抗RANKL全人單克隆抗體注射液(Prolia®生物類似藥),用於治療具有骨折高危風險的絕經後婦女骨質疏鬆症;增加具有骨折高危風險的男性骨質疏鬆症患者的骨量;治療骨折高危風險的糖皮質激素誘導的男性和女性骨質疏鬆症;增加因非轉移性前列腺癌接受雄激素剝奪治療所致的具有骨折高危風險的男性的骨量及增加因乳腺癌接受芳香化酶抑制劑治療所致的具有骨折高危風險的女性的骨量。
根據公開的財務報吿,Prolia®(LY 06006的市場可比產品)於2019年的全球銷售額為26.7億美元,同比年增長率為16.6%。於2020年1月至9月的全球銷售額為20.14億美元,同比增長率為4.9%。該產品於2020年6月獲得中國上市批准。山東博安共擁有四個抗體發現平台,即全人抗體轉基因小鼠及噬菌體展示技術、雙特異性T細胞銜接系統技術、抗體偶聯技術及納米抗體平台。基於這四個抗體發現平台,山東博安已開發出10餘個擁有國際知識產權保護的創新抗體,其中1個在I期臨牀階段,4個預期即將進入臨牀階段。
除創新抗體外,山東博安還擁有8個生物類似藥,其中LY 01008(Avastin的生物類似藥)已申報中國上市申請;LY 06006(Prolia的生物類似藥)處於中國III期臨牀及歐美I期臨牀;LY 01011(Xgeva的生物類似藥)處於中國III期臨牀;LY 09004(Eylea的生物類似藥)處於中國III期臨牀。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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