You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
复星医药(02196.HK):马来酸阿伐曲泊帕片获国家药监局临床试验注册审评受理
格隆汇 08-12 20:46

格隆汇 8 月 12日丨复星医药(02196.HK)公告,近日,上海复星医药(集团)股份有限公司(以下简称“公司”)控股子公司上海复星医药产业发展有限公司(以下简称“复星医药产业”)收到《受理通知书》,其获许可的马来酸阿伐曲泊帕片(以下简称“该新药”)用于慢性免疫性血小板减少症适应症(ITP)获国家药品监督管理局(以下简称“国家药监局”)临床试验注册审评受理。

复星医药产业于2018年3月获美国AkaRx,Inc.(为DovaPharmaceuticals,Inc.控股子公司;以下简称“AkaRx”)关于该新药在区域内(即中国大陆及香港特别行政区)的独家销售代理权(包括为实现销售享有的独家注册、开发权)的许可,AkaRx仍为该新药在区域内的权利人,复星医药产业在区域内的销售将由AkaRx负责供货。该新药为化学药品,主要适用于(1)择期行诊断性操作或者手术的慢性肝病相关血小板减少症的成年患者、(2)肿瘤化疗引起的血小板减少症、(3)慢性免疫性血小板减少症等。

截至公告日,该新药适用于择期行诊断性操作或者手术的慢性肝病相关血小板减少症的成年患者已于美国、欧盟、中国境内(不包括港澳台地区,下同)上市,适用于慢性免疫性血小板减少症已于美国上市。截至公告日,该新药适用于肿瘤化疗引起的血小板减少症于中国境内处于III期临床试验中。

根据IQVIAMIDASTM最新数据(由IQVIA提供,IQVIA是全球领先的医药健康产业专业信息和战略咨询服务提供商),2019年度,阿伐曲泊帕片于全球销售额约为343万美元。

Follow us
Find us on Facebook, Twitter , Instagram, and YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
uSMART
Wealth Growth Made Easy
Open Account