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.
九典制藥(300705.SZ):撤回藥品註冊申請
格隆匯 08-11 16:33

格隆匯8月11日丨九典制藥(300705.SZ)公吿,湖南九典制藥股份有限公司(以下簡稱“公司”)於近日向國家藥品監督管理局提交了撤回椒七麝凝膠貼膏藥品註冊申請報吿。椒七麝凝膠貼膏是公司基於臨牀經驗方開發的局部經皮給藥製劑,具有温經散寒、活血止痛的作用,用於寒凝血瘀所致的痺病,症見關節疼痛、壓痛、局部畏寒、得温痛減、關節活動不利、僵硬重滯;骨性關節炎等見上述證候者。

椒七麝凝膠貼膏於2006年4月獲得國家藥品監督管理局藥物臨牀試驗批件,2008年8月取得Ⅱ期臨牀試驗總結報吿,2010年5月取得Ⅲ期臨牀試驗總結報吿。2016年2月國家藥品監督管理局發佈《關於開展藥物臨牀實驗數據自查核查工作的公吿》,公司對椒七麝凝膠貼膏完成臨牀實驗數據自查,根據現行技術指導原則及法規的要求,並與藥品審評中心溝通後重新開展Ⅲ期臨牀試驗,於2023年11月取得第二次Ⅲ期臨牀試驗總結報吿,2023年12月公司向國家藥品監督管理局遞交了上市許可申請並獲得受理。

因椒七麝凝膠貼膏需進一步完善有關試驗數據,公司已於近日提交了該產品的撤回註冊申請報吿,尚未收到國家藥品監督管理局簽發的《藥品註冊申請終止通知書》。後續公司將根據國家藥品監督管理局的要求,待進一步完善相關研究後再次啟動本產品的申報註冊工作。

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