欧康维视生物-B(01477.HK)OT-401获准在海南博鳌开展真实世界研究
格隆汇12月28日丨欧康维视生物-B(01477.HK)公告,集团的核心产品OT-401(YUTIQ)已获准在中国海南省博鳌乐城医疗旅游先行区开展真实世界研究,为公司的重要里程碑,进一步凸显了其创新力并可能加快OT-401在中国的新药申请提交审批。
公司的核心产品OT-401(YUTIQ)是一种从EyePoint Pharmaceuticals,Inc.引入许可的同类首创、创新的可注射、缓释微型植入剂,用于治疗累及眼后段的慢性非感染性葡萄膜炎。OT-401是一种无菌、非生物降解的玻璃体内植入剂,该植入剂将在门诊单次植入后36个月内,按经控制速度持续释放共计0.18毫克活性成分氟轻松(一种皮质类固醇)。迄今为止,YUTIQ是首款且唯一经美国食品药品监督管理局批准可释放氟轻松长达36个月的葡萄膜炎疗法。
得力于公司科学且严谨的真实世界研究计划以及公司专业眼科临床研究团队采取的详细研发策略,公司的OT-401真实世界研究数据预期将加快OT-401在中国的商业化进程。
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