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博安生物(06955.HK):阿柏西普眼內注射溶液(BA9101)在中國完成Ⅲ期臨牀試驗及計劃遞交上市申請
格隆匯 04-08 16:35

博安生物(06955.HK)公吿,公司研發的阿柏西普眼內注射溶液("BA9101")已在中國完成Ⅲ期臨牀試驗(臨牀有效性安全性比對試驗),並計劃遞交上市申請。

阿柏西普是由人血管內皮生長因子受體(VEGFR)胞外結構域(即VEGFR1Ig2區和VEGFR2Ig3區)與人IgG1的Fc結構域融合後形成的同源二聚體糖蛋白,是一種可與VEGF-A、VEGF-B、PlGF結合的可溶性誘騙受體,可抑制內源性VEGF受體與VEGF-A和PlGF的結合和激活,從而治療視網膜及脈絡膜的病理性新生血管類眼部疾病。

原研藥艾力雅®(EYLEA®)於2011年和2012年分別在美國和歐盟獲批上市,目前在全球範圍內已獲批的適應症包括新生血管(濕性)年齡相關性黃斑變性(nAMD)、糖尿病性黃斑水腫(DME)、視網膜靜脈阻塞後黃斑水腫(RVO)、糖尿病性視網膜病變(DR)、近視脈絡膜新生血管(mCNV)和早產兒視網膜病變(ROP)。艾力雅®2018年在中國獲批上市,適應症為nAMD和DME。

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