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復宏漢霖-B(02696.HK):HLX04-O用於濕性年齡相關性黃斑變性治療的臨牀試驗申請獲澳大利亞藥品管理局批准
格隆匯 01-29 20:05

格隆匯1月29日丨復宏漢霖-B(02696.HK)公佈,近日,用於濕性年齡相關性黃斑變性(wAMD)治療的重組抗VEGF人源化單克隆抗體眼用注射液HLX04-O通過Therapeutic Goods Administration(澳大利亞藥品管理局)的臨牀試驗備案,被批准於澳大利亞開展3期臨牀試驗(CTN號:CT-2020-CTN-04843-1),該項目在澳大利亞的3期臨牀研究擬於近期啟動。

HLX04-O是在公司自主研發的貝伐珠單抗生物類似藥HLX04的基礎上,根據眼科用藥的需求對HLX04的處方、規格和生產工藝進行優化,在活性成分不變的基礎上,開發的新的眼科製劑產品,擬用於濕性年齡相關性黃斑變性的治療。通過可比性研究表明生產工藝和製劑處方的變更對藥物製劑的質量、安全性和有效性未產生不利影響。HLX04-O主要作用機制為:通過抑制VEGF與其位於內皮細胞上的受體Flt-1和KDR相結合,抑制其酪氨酸激酶信號通路激活,抑制內皮細胞增生,減少新生血管生成,從而治療血管增生眼部疾病。

截至本公吿日期,於全球上市的貝伐珠單抗產品均無濕性年齡相關性黃斑變性適應症。截至目前,於全球範圍內上市的針對濕性年齡相關性黃斑變性適應症的大分子藥物有艾力雅(阿柏西普),諾適得(雷珠單抗)和朗沐(康柏西普)等。根據IQVIAMIDASTM的數據顯示,2019年,相關藥物的銷售額為:艾力雅36.53億美元,諾適得42.26億美元,朗沐0.95億美元;2020年1月至9月,相關藥物的銷售額為:艾力雅43.46億美元,諾適得29.03億美元,朗沐0.75億美元。

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