和黄医药向美国FDA滚动提交索凡替尼新药上市申请
和黄医药(HCM.US)公布,已开始向美国食品药品监督管理局(FDA)滚动提交旗下产品索凡替尼(Surufatinib),用於治疗胰腺和非胰腺神经内分泌瘤的新药上市申请第一部分,并计划於2021年上半年完成新药上市申请提交,为和黄医药的首个美国新药上市申请。
FDA於今年初授予的快速通道资格,允许和黄医药以滚动提交的方式分批提交新药上市申请。和黄医药并计划启动一项扩充疗程方案,以确保选择有限的患者能够获得重要治疗,FDA批准该方案的监管许可後,预计将於2021年第一季度开始早期疗程方案的注册。
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.