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歐康維視生物-B(01477.HK):OT-702 III期臨牀試驗於中國完成受試者入組

格隆匯3月13日丨歐康維視生物-B(01477.HK)宣佈,OT-702(阿柏西普生物類似藥)已於2023年3月3日完成III期臨牀試驗的416名受試者入組,標誌着OT-702在中國的III期臨牀試驗完成受試者入組。

OT-702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OT-702與EYLEA®(阿柏西普眼內注射溶液)對治療濕性年齡相關性黃斑變性的有效性及安全性。根據2020年10月訂立的合作及獨家推廣協議,集團與綠葉製藥集團有限公司(2186.HK)的附屬公司山東博安生物技術有限公司("博安生物")(6955.HK)共同開發OT-702的III期臨牀試驗。根據該協議,集團已獲得博安生物在中國內地推廣及商業化OT-702的獨家權利。

OT-702 為重組人血管內皮生長因子受體-抗體融合蛋白眼用注射液。作為EYLEA®(阿柏西普眼內注射溶液)的生物類似藥,OT-702適用治療新生血管濕性年齡相關性黃斑變性、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,OT-702可與VEGF-A、VEGF-B及PlGF等細胞因子結合,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的病理性新生血管類眼部疾病。OT-702與EYLEA®(阿柏西普眼內注射溶液)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,OT-702具有良好的安全性及耐受性。

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