歐康維視生物-B(01477.HK):OT-401新藥申請獲國家藥品監督管理局受理
格隆匯 4 月 7日丨歐康維視生物-B(01477.HK)公吿,公司的主要候選藥物一OT-401(YUTIQ)新藥申請已於2021年4月7日獲中華人民共和國國家藥品監督管理局("國家藥監局")受理。OT-401(YUTIQ)為公司首款眼科藥物,其新藥申請已獲國家藥監局受理,並且該藥物亦為首款在中國內地提交新藥申請的緩釋微型植入劑,其在長達36個月內擁有經控制釋放速度。這是國家藥監局首次受理基於真實世界研究數據的新藥申請。
OT-401(YUTIQ)是一種從EyePoint Pharmaceuticals, Inc.(一家普通股股份於納斯達克股票市場上市(股份代號:EYPT)的公司)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。
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