欧康维视生物-B(01477.HK)：OT-301(NCX470)在中国获批III期临床试验
格隆汇 10 月 23日丨欧康维视生物-B(01477.HK)公告，作为集团产品管线一的OT-301(NCX470)日前获中华人民共和国("中国")国家药品监督管理局药品审评中心批准，在中国开展公司计划的两项III期临床试验的其中一项。OT-301(NCX470)是同类首创的第二代一氧化氮(NO)供体型贝美前列素类似物，旨在降低开角型青光眼及高眼压症患者的眼内压力("眼内压")。
与拉坦前列素滴眼液(0.005%浓度，在中国用于青光眼及高眼压症的最广泛的一线处方治疗药物)相比，OT-301(NCX470)滴眼液(0.065%浓度)在其II期临床试验中表现出更好的降低眼内压的治疗效果。透过在贝美前列素(被认为是迄今为止获批的最有效前列腺素类似物)中添加一氧化氮介导功效，OT-301(NCX470)有望成为降低青光眼及高眼压症患者眼内压的潜在同类最佳治疗药物。
此乃公司首次获批于中国开展的国际多中心III期临床试验。公司与其授权合伙人NicoxS.A.("Nicox"，NCX470的发起人)拟于取得监管机构批准后在美国及中国就OT-301(NCX470)开展两项国际多中心III期临床试验，旨在评估OT-301(NCX470)滴眼液(0.1%浓度)相比拉坦前列素滴眼液(0.005%浓度)对具有开角型青光眼或高眼压症状的受试者的安全性及功效。
具体而言，该等三期临床试验旨在证明OT-301(NCX470)不逊于(主要疗效指标)甚至优于拉坦前列素滴眼液(0.005%浓度)，同时证明计划给药时长达12个月时耐受性良好。Nicox已于2020年6月在美国开始首项III期临床试验。与Nicox合作开展OT-301国际多中心临床试验将进一步提升公司的研究实力，及将更好地配合OT-301在中国的预期新药申请。
OT-301(NCX470)由Nicox发明及开发。Nicox授予集团若干专利及专有技术的独家权利，以于大中华地区、韩国及东南亚另外12个国家开发、生产、制作、进口、出口、使用、分销、推广、宣传、许诺销售及销售OT-301(NCX470)。
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