復宏漢霖(02696.HK):重組抗VEGF人源化單克隆抗體注射液HLX04-O用於溼性年齡相關性黃斑變性(wAMD)治療的3期臨牀研究達到主要研究終點
格隆匯4月2日丨復宏漢霖(02696.HK)公告,近日,重組抗VEGF人源化單克隆抗體注射液HLX04-O("HLX04-O")在一項於溼性年齡相關性黃斑變性(wetage-related macular degeneration, wAMD)中國患者中開展的3期臨牀研究達到主要研究終點。
本研究爲一項多中心、隨機、雙盲、陽性對照的非劣效3期臨牀研究,旨在比較HLX04-O與雷珠單抗玻璃體內注射("IVT")在溼性年齡相關性黃斑變性(wAMD)患者中的有效性和安全性。入組的患者按照1:1的比例隨機接受HLX04-O(1.25mg)IVT或雷珠單抗(0.5mg)IVT給藥,每四周一次,在患者未發生死亡、撤回知情同意、失訪或申辦方終止研究的情況下,持續治療一年。
本次研究的主要研究終點爲第48周最佳矯正視力("BCVA")較基線改善的平均字母數變化,次要研究終點爲其他有效性、安全性、耐受性及藥代動力學指標。研究結果顯示,HLX04-O組第48周BCVA較基線改善的平均字母數變化結果非劣於雷珠單抗組,達到主要研究終點。此外,HLX04-O和雷珠單抗對溼性年齡相關性黃斑變性(wAMD)患者人羣整體、眼部、非眼部的安全性特徵均相似,且安全性良好。
截至本公告日,於中國境內上市的貝伐珠單抗產品均無溼性年齡相關性黃斑變性(wAMD)適應症。根據IQVIACHPA的最新數據(IQVIA是全球醫藥健康產業專業信息和戰略諮詢服務提供商),2024年,於中國境內上市的針對溼性年齡相關性黃斑變性(wAMD)適應症的藥物的銷售額約爲人民幣41.8億元。
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