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.
山東新華製藥股份(00719.HK)收到國家藥監局核准簽發的阿託伐他汀鈣片《藥品補充申請批准通知書》

格隆匯5月25日丨山東新華製藥股份(00719.HK)公吿,近日,山東新華製藥股份有限公司(“新華製藥”、“公司”)收到國家藥品監督管理局核准簽發的阿託伐他汀鈣片(“該產品”)《藥品補充申請批准通知書》,該產品上市許可持有人變更申請獲得批准。

審批結論:根據《中華人民共和國藥品管理法》及相關規定,經審查,該產品此次申請事項符合藥品註冊的有關要求,同意按照《藥品上市後變更管理辦法(試行)》相關規定,批准該產品上市許可持有人變更申請,發給《藥品補充申請批准通知書》。

阿託伐他汀鈣片是由輝瑞公司研發,於1996年在美國獲FDA批准上市,商品名:“LIPITOR”,2000年進入中國。有關數據顯示,該品種國內市場近人民幣160億元,中國城市公立醫院2021年銷售總額約為人民幣23.29億元。

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