綠葉製藥(02186.HK)：地舒單抗注射液(LY06006/LY01011)提交美國臨牀試驗申請
格隆匯5月8日丨綠葉製藥(02186.HK)宣佈，集團附屬山東博安已就其產品重組抗RANKL全人單克隆抗體注射液(地舒單抗注射液，LY06006/LY01011)向美國食品藥品監督管理局提交臨牀試驗(IND)申請。這亦是集團首個於海外提交的生物藥申請。
劑量為60毫克╱毫升的地舒單抗注射液(LY06006)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患者的骨量；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患者的骨量。
劑量為120毫克/1.7毫升的地舒單抗注射液(LY01011)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；用於治療雙膦酸鹽難治性惡性腫瘤引發的高鈣血癥(HCM)。
LY06006和LY01011分別為Prolia和Xgeva的生物類似藥，在中國分別處於臨牀III期和臨牀I期。根據公開的財務報告，Prolia(LY06006的市場可比產品)於2019年的全球銷售額為26.7億美元，同比增長率為16.6%，而該產品尚未於中國推出。Xgeva(LY01011的市場可比產品)於2019年的全球銷售額為19.4億美元，同比增長率為8.3%。該產品於2019年5月才於中國上市。
除LY06006/LY01011外，集團亦有5種處於不同開發階段的生物類似藥品種，包括LY01008(Avastin生物類似藥)，LY09004(Eylea生物類似藥)，LY01012(Zaltrap生物類似藥)，LY01015(Opdivo生物類似藥)，LY05008(Trulicity生物類似藥)。其中，LY01008(貝伐珠單抗注射液，Avastin生物類似藥)的上市許可申請已獲中國國家藥品監督管理局藥品審評中心受理。
公司表示，集團將持續加大對於生物製藥領域的研發投入，加快推進創新生物藥的佈局，進一步豐富集團產品線。
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