綠葉製藥(02186.HK)：博安生物LY09004在中國完成III期臨牀首例患者給藥
格隆匯2月8日丨綠葉製藥(02186.HK)宣佈，公司子公司山東博安生物技術有限公司(“山東博安”)的重組人血管內皮生長因數受體—抗體融合蛋白眼用注射液(阿柏西普眼內注射液，LY09004)已於中國完成III期臨牀首例患者給藥。
LY09004為重組人血管內皮生長因數受體—抗體融合蛋白眼用注射液(規格11.12毫克(0.278ml)╱瓶)。作為EYLEA®(阿柏西普眼內注射液)的生物類似藥，LY09004適用於治療新生血管濕性年齡相關性黃斑變性(wAMD)、視網膜靜脈阻塞(RVO)後黃斑水腫、糖尿病性黃斑水腫(DME)及糖尿病性視網膜病變(DR)的患者。作為可溶性的誘餌受體，LY09004可與VEGF-A、VEGF-B及PlGF等細胞因數結合，阻斷VEGFR的下游信號通路、抑制新生血管生成並降低血管通透性，從而治療視網膜及脈絡膜病理性新生血管類眼部疾病。
LY09004與EYLEA®(阿柏西普眼內注射液)的頭對頭比較研究表明，在理化特性及生物學活性上具有高度相似性。其I期臨牀試驗結果顯示，LY09004具有良好的安全性及耐受性，並無嚴重不良反應發生。截至本公吿日期，LY09004的III期臨牀試驗計劃為一項隨機、雙盲、平行對照及多中心臨牀試驗，以比較LY09004與EYLEA®(阿柏西普眼內注射液)對於治療濕性年齡相關性黃斑變性(wAMD)的有效性及安全性。
此前，山東博安與歐康維視生物(股份代號：1477.HK)的全資附屬公司歐康維視(浙江)醫藥有限公司(“浙江歐康維視”)訂立合作及獨家推廣協議，以共同開發LY09004在中國的III期臨牀試驗。此外，山東博安授予浙江歐康維視在中國內地(就協議而言，不包括香港、澳門及台灣)獨家推廣及商業化LY09004的權利。
董事會相信，歐康維視生物作為知名眼科公司，具備專業的團隊，將加快推動LY09004的臨牀試驗及商業化，以滿足中國患者迫切的臨牀需求，增強集團在生物製品領域的行業地位。
除中國市場外，山東博安還在美國、日本、歐洲等國家或地區開發該等產品。根據公開資料顯示，EYLEA®(阿柏西普眼內注射液)於2019年的全球銷售額為75.42億美元，同比增長12%，可見該等產品在全球市場的需求及增長潛力。
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