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於歐盟國家獲批
格隆匯4月20日丨復宏漢霖-B(02696.HK)公吿，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的臨牀試驗申請獲拉脱維亞國家藥物署批准，這是HLX04-O首次於歐盟國家獲批開展臨牀試驗。
公司已先後於匈牙利、西班牙、捷克共和國等歐盟國家遞交HLX04-O的臨牀試驗申請，預計將於近期陸續獲批。HLX04-O的3期、全球、多中心臨牀研究擬於近期啟動，以進一步評估HLX04-O治療濕性年齡相關性黃斑變性的有效性及安全性。根據臨牀研究方案，該研究將於中國大陸、澳大利亞、俄羅斯聯邦、新加坡、西班牙、波蘭等國家╱地區開展。
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，在活性成份不變的基礎上，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。2021年1月、3月，HLX04-O用於濕性年齡相關性黃斑變性的治療已分別獲批准於澳大利亞、美國開展3期臨牀試驗。
截至本公吿日，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(wAMD)適應症，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的最新數據，2020年相關藥物於全球範圍內的銷售額分別為：艾力雅60.71億美元，諾適得39.05億美元，朗沐1.06億美元。
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