綠葉製藥(02186.HK)附屬治療骨折骨質疏鬆症新藥向美國提交臨床試驗申請
綠葉製藥(02186.HK)公布,附屬山東博安生物技術已就其產品重組抗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床試驗(IND)申請。這亦是集團首個於海外提交的生物藥申請。
集團指,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(酉每)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巨細胞瘤,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症(HCM)。
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