博安生物(06955.HK)：阿柏西普眼內注射溶液(BA9101)在中國上市申請獲受理
格隆匯7月16日丨博安生物(06955.HK)發佈公吿，公司自主研發的阿柏西普眼內注射溶液（BA9101）的上市申請已獲中國國家藥品監督管理局藥品審評中心受理（CDE）。BA9101為艾力雅（EYLEA）的生物類似藥，擬用於治療成人新生血管（濕性）年齡相關性黃斑變性（nAMD）及糖尿病性黃斑水腫（DME）。
阿柏西普是由人血管內皮生長因子受體(VEGFR)胞外結構域（即VEGFR1 Ig2區和VEGFR2 Ig3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nAMD、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。
根據CDE發佈的《生物類似藥相似性評價和適應症外推技術指導原則》，BA9101可申請獲批艾力雅（EYLEA）在中國獲批的全部適應症。國際上，阿柏西普作為nAMD、DME、RVO、DR、mCNV和ROP的一線用藥被廣泛應用於這些疾病的治療中，並在臨牀需求的推動下，呈現廣闊的市場前景。根據IQVIA數據，2023年中國眼部抗新生血管藥物的市場銷售額約為38.68億元人民幣，較2022年增長24.5%；其中，艾力雅在中國的銷售額約為8.38億元人民幣，較2022年增長30.1%。此外，根據公開數據顯示，2023年艾力雅（EYLEA）在全球的銷售額達到92.1億美元。
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