智通财经APP获悉，荣昌生物(09995)早盘大涨近14%，该股年内累计涨幅已高达6倍。截至发稿，涨13.9%，报110.2港元，成交额4.94亿港元。
消息面上，9月9日，荣昌生物宣布，该公司自主研发的全球首创BLyS/APRIL双靶点融合蛋白创新药泰它西普（商品名：泰爱®）用于治疗干燥综合征（Sjogren's syndrome）的上市申请，已获国家药品监督管理局药品审评中心（CDE）正式受理，成为干燥综合征领域全球首个申请上市的生物药。据悉，目前全球尚无治疗干燥综合征的靶向药物获批上市。
目前，泰它西普的干燥综合征适应症已获美国FDA授予的快速通道资格并获准在美国开展Ⅲ期临床试验，治疗系统性红斑狼疮（SLE）、类风湿关节炎（RA）、全身型重症肌无力（gMG）三个适应症已先后在国内上获批市。
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.