海思科(002653.SZ):创新药环泊酚乳状注射液获受理通知书
格隆汇1月19日丨海思科(002653.SZ)公告,海思科医药集团股份有限公司(以下简称“公司”)及公司全资子公司四川海思科制药有限公司、辽宁海思科制药有限公司于2020年01月19日收到国家药品监督管理局下发的《受理通知书》,基本情况如下:
环泊酚乳状注射液(以下简称“环泊酚”)是公司开发的全新的具有自主知识产权的静脉麻醉药物,拟用于手术全麻诱导、内镜诊疗的镇静/麻醉、ICU镇静等适应症。按我国新化学药品注册分类规定,其药品注册分类为化药1类。
环泊酚于2016年1月获得国家食品药品监督管理局下发的《药物临床试验批件》,启动“消化道内镜诊断和治疗镇静和/或麻醉”和“全身麻醉诱导”适应症的临床试验。“消化道内镜诊断和治疗镇静和/或麻醉”适应症新药申请(特殊审批程序)于2019年07月29日获得国家药品监督管理局受理(受理号:CXHS1900019国、CXHS1900020国),“全身麻醉诱导”适应症新药申请(特殊审批程序)于2020年1月19日获得国家药品监督管理局受理。
基于未来开拓环泊酚国际市场的考虑,公司拟在美国开展临床试验,公司已于2019年7月31日与美国FDA召开了Pre-IND会议,计划2020年底启动美国全麻诱导III期临床试验。
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.