歌礼制药-B(01672)今日早盘表现强劲,股价涨幅超过8%。截至发稿时,该股上涨8.07%,报10.31港元,成交额达926.46万港元。
该公司近日发布公告,其专有的每日一次口服小分子胰高血糖素样肽-1受体(GLP-1R)激动剂ASC30,用于长期体重管理的全球III期临床项目已顺利完成首例受试者给药。该药物目前正处于临床研究阶段,旨在开发用于长期体重管理及糖尿病治疗。
根据公告披露,歌礼制药-B预计将于2028年第三季度公布AURORA III期临床项目的顶线数据。公司计划于2028年底向美国食品药品监督管理局(FDA)递交新药上市申请(NDA),并预计于2029年初向欧洲药品管理局(EMA)提交上市许可申请(MAA)。
歌礼制药-B管理层表示,公司拥有稳健的资产负债表和充裕的现金储备,足以覆盖该项目在美国和欧洲的监管申请费用,并可支持公司日常运营至2029年。
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.
Comments