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.
景峯醫藥(000908.SZ):尚進慢性心絞痛治療藥獲美國ANDA批准文號
格隆匯 03-24 16:01

格隆匯3月24日丨景峯醫藥(000908.SZ)公佈,近日,公司控股子公司Sungen Pharma, LLC(下稱“尚進”)收到美國食品藥品監督管理局(即美國FDA)的通知,尚進向美國FDA申報的雷諾嗪口服緩釋片的簡略新藥申請(ANDA,即美國仿製藥申請,申請獲得美國FDA審評批准意味着申請者可以生產並在美國市場銷售該產品)已獲得批准。

雷諾嗪可降低心率不齊的發生,包括室性心率失常、新發動脈纖維顫動、因冠狀動脈疾病導致的心動過緩,還可降低糖尿病病人的糖化血紅素。雷諾嗪緩釋片是用於治療慢性心絞痛,尤其適合於對常規藥物最大劑量無效或出現嚴重副反應或不能耐受者、使用多種藥物治療者、或有慢性阻塞性肺部疾病或慢性心功能不全者。

雷諾嗪緩釋片是長效緩控釋製劑,研發、臨牀等效試驗壁壘較高。目前美國市場的主要生產商有魯賓(Lupin)、梯瓦(Teva)、太陽製藥(Sun)等。根據IMS數據顯示,雷諾嗪口服緩釋片2018年在美國市場的銷售額為9.5億美元,2019年為4.8億美元。

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