海西新药（02637）早盘一度涨超14%，截至发稿，股价上涨5.42%，现报196.40港元，成交额2128.27万港元。
海西新药发布公告，公司自主研发的创新药候选分子HX9428治疗新生血管性年龄相关性黄斑变性（nAMD）的美国临床试验申请已获美国食品药品监督管理局（FDA）批准，正式启动II期临床试验；同时，公司在中国启动第二项采用阳性对照（阿柏西普）的II期临床试验，计划入组60例患者。
公开资料显示，HX9428为口服候选创新药，旨在突破当前nAMD治疗主要依赖玻璃体腔注射的局限，提供便捷给药方案，提升患者长期治疗依从性。此前已完成I期及II期剂量扩展研究。公司表示，此次美国II期获批及中国对照研究启动，标志着全球临床开发取得重要进展。HX9428尚未获批上市，安全性和有效性需进一步验证。
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