復宏漢霖(02696.HK):地舒單抗生物類似藥HLX14(重組抗RANKL全人單克隆抗體注射液)用於治療骨折高風險的絕經後婦女的骨質疏鬆症的國際多中心3期臨牀研究達到主要研究終點
格隆匯4月5日丨復宏漢霖(02696.HK)發佈公吿,近日,一項公司自主研發的地舒單抗生物類似藥HLX14(重組抗RANKL全人單克隆抗體注射液)(HLX14)用於治療骨折高風險的絕經後婦女的骨質疏鬆症的國際多中心3期臨牀研究達到了主要研究終點。
本研究是一項隨機、雙盲、國際多中心、平行對照的3期臨牀試驗,旨在比較HLX14與原研地舒單抗(Prolia) 在高危骨折風險的絕經後骨質疏鬆症女性受試者中的有效性、安全性、耐受性和免疫原性。合格的受試者將按1:1的比例隨機分為兩組,每六個月接受一次皮下注射60mg的HLX14或原研地舒單抗(Prolia) 治療。研究的主要終點為中心影像評估的基線至第52周(D365)的腰椎骨密度(BMD)的變化率,以及基線至第26周(D183)的血清膠原蛋白C端肽(s-CTX)較基線改變百分比-時間曲線下面積(AUEC0-26W)。次要終點包括其他療效評估和藥效學特徵、伴發事件發生率、安全性、藥代動力學特徵及免疫原性。本研究主要終點已達到。
HLX14是公司自主研發的地舒單抗生物類似藥,擬用於治療骨折高風險的絕經後婦女的骨質疏鬆症及╱或與原研藥藥品標籤相符的其他適應症。目前HLX14的原研藥地舒單抗已在多個國家和地區以不同商品名獲批用於如骨折高風險的絕經後婦女的骨質疏鬆症等一系列不同適應症。2022年6月,公司與Organon LLC(Organon & Co.,的全資附屬公司)簽訂協議,同意向其授出一項獨家許可,供其及其附屬公司於除中國境內及港澳台地區以外全球範圍內商業化HLX14。2024年1月,一項HLX14在中國男性健康受試者中開展的1期臨牀研究已成功完成。
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