歐康維視生物-B(01477.HK):OT-1001獲納入國家藥品監督管理局優先審查和批准程序
格隆匯4月26日丨歐康維視生物-B(01477.HK)宣佈,具有抗過敏特性的強效及高選擇性組胺H-1受體拮抗劑OT-1001 (ZERVIATE)已於近日獲中華人民共和國國家藥監局納入優先審查和批准程序。
OT-1001 (ZERVIATE)由Nicox Ophthalmics, Inc.("Nicox")研發。集團於2019 年3 月獲Nicox獨家許可,以在大中華地區開發、製造、委託製造、進口、出口、使用、分銷、營銷、推廣、要約出售及銷售(或另行進行商業化)OT-1001(ZERVIATE),並於2020年3月將獨家權利擴大至東南亞11個國家。OT-1001是抗組胺藥鹽酸西替利嗪(ZYRTEC®的活性成分)的首款且唯一的滴眼液配方,目前已於美國上市,用於治療過敏性結膜炎相關的眼癢。2023年4月,OT-1001新藥上市申請獲國家藥監局受理。
國家藥監局的優先審評審批程序旨在加快審批解決未滿足醫療需求或可能對現有治療方案提供重大改進的藥物。OT-1001 (ZERVIATE)獲納入國家藥監局優先審評審批程序,將加快其新藥上市申請的審評審批程序,這是實現OT-1001(ZERVIATE)商業化的重要一步。
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