歐康維視生物-B(01477.HK)OT-401獲准在海南博鰲開展真實世界研究
格隆匯12月28日丨歐康維視生物-B(01477.HK)公吿,集團的核心產品OT-401(YUTIQ)已獲准在中國海南省博鰲樂城醫療旅遊先行區開展真實世界研究,為公司的重要里程碑,進一步凸顯了其創新力並可能加快OT-401在中國的新藥申請提交審批。
公司的核心產品OT-401(YUTIQ)是一種從EyePoint Pharmaceuticals,Inc.引入許可的同類首創、創新的可注射、緩釋微型植入劑,用於治療累及眼後段的慢性非感染性葡萄膜炎。OT-401是一種無菌、非生物降解的玻璃體內植入劑,該植入劑將在門診單次植入後36個月內,按經控制速度持續釋放共計0.18毫克活性成分氟輕鬆(一種皮質類固醇)。迄今為止,YUTIQ是首款且唯一經美國食品藥品監督管理局批准可釋放氟輕鬆長達36個月的葡萄膜炎療法。
得力於公司科學且嚴謹的真實世界研究計劃以及公司專業眼科臨牀研究團隊採取的詳細研發策略,公司的OT-401真實世界研究數據預期將加快OT-401在中國的商業化進程。
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