智通财经APP获悉，海西新药(02637)涨超3%，截至发稿，涨2.89%，报195.5港元，成交额618.26万港元。
消息面上，海西新药发布公告，本公司自主研发的创新药项目HXP056的候选药物分子HX9428，已于2026年8月31日正式向中国国家药品监督管理局(NMPA)药品审评中心(CDE)递交新适应症糖尿病性黄斑水肿(DME)的IIa期新药临床试验申请(IND)。DME是HX9428推进的第二个适应症，标志着这款口服眼底创新药研发的又一个里程碑。公司表示，将继续全力推进HX9428在中美两地多项临床研究的进展。
公司表示，HX9428已获美国食品药品监督管理局(U.S. Food and Drug Administration，简称“FDA”)授予快速通道资格(Fast Track Designation，简称“FTD”)，并正同步在中美两地开展第一个适应症新生血管性年龄相关性黄斑变性(neovascular age-related macular degeneration，简称“nAMD”，亦称湿性年龄相关性黄斑变性，wAMD)的II期临床研究。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.