億勝生物科技(01061.HK)：HLX04-O的1/2期臨牀研究結果顯示其安全性及耐受性良好
格隆匯7月26日丨億勝生物科技(01061.HK)宣佈，近日，用以治療濕性AMD的重組抗血管內皮生長因子("anti-VEGF")人源化單克隆抗體眼用注射液HLX04-O("HLX04-O")的1/2期臨牀研究結果顯示其安全性及耐受性良好，並展現出初步療效。
此1/2臨牀研究是一項單臂、開放標籤及多中心的研究，旨在評估玻璃體內注射("IVT")HLX04-O在活動性濕性AMD患者中的安全性和初步療效，幷包括兩部分。第一部分為安全導入期，共入組6名患者，而第二部分為單臂、開放標籤及多中心的二期研究，共入組20名患者(包括第一部分中的6名患者)。所有患者均接受每四周一次的HLX04-OIVT(1.25mg/0.05mL)，直至發生死亡、撤回知情同意、失訪、申辦方終止研究或完成一年治療期。第一部分的主要終點為在HLX04-O首次給藥後四周內發生與HLX04-O相關的安全性事件，次要終點為第一、第四次給藥後的HLX04-O全身藥代動力學特徵。第二部分的主要終點為第12周時最佳矯正視力(BCVA)較基線改善的平均字母數變化，次要終點包括其他療效指標、安全性、免疫原性和全身藥代動力學特徵。研究結果顯示，HLX04-OIVT在濕性AMD患者中安全性和耐受性良好，且展現出初步療效。
據悉，HLX04-O是在復宏漢霖自主研發的漢貝泰®(貝伐珠單抗注射液)的基礎上，根據眼科用藥的需求對漢貝泰®(貝伐珠單抗注射液)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AMD的治療。於2021年11月，用於治療濕性AMD的HLX04-O的三期臨牀研究於中國完成首例患者給藥。截至目前，HLX04-O在濕性AMD患者中開展的國際多中心三期臨牀研究先後於拉脱維亞(一個歐盟國家)、澳大利亞及美國等國家完成首例患者給藥。
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