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.
普利製藥(300630.SZ):注射用比伐蘆定獲得澳大利亞藥物管理局(TGA)上市許可
格隆匯 08-15 15:40

格隆匯8月15日丨普利製藥(300630.SZ)公佈,公司於近日收到了澳大利亞藥物管理局(TGA)簽發的注射用比伐蘆定的上市許可。

比伐蘆定是一種人工合成的抗凝血藥物,其注射劑由The Medicine Company研發,於2000年12月獲美國食品藥品監督管理局(FDA)批准上市,注射用比伐蘆定原研藥目前在美國的申請持有人已轉變為Sandoz Inc.,2004年9月獲歐洲藥物管理局(EMA)批准上市,2019年2月獲國家藥品監督管理局(NMPA)批准上市。

普利製藥的注射用比伐蘆定成功研發後,分別提交了歐洲、中國、美國、英國、以色列、加拿大和澳大利亞等多個國家和地區的仿製藥註冊申請,屬於共線生產品種。本品於2020年4月獲得了荷蘭藥物評價委員會(CBG)的批准;於2020年6月獲得了德國聯邦藥物和醫療器械管理局(BfArM)的批准;於2020年9月獲得國家藥品監督管理局(NMPA)的批准;2021年2月注射用比伐蘆定ANDA美國挑戰專利成功,並於2021年5月獲得美國食品藥品監督管理局(FDA)的批准;於2021年9月獲得英國藥品和健康產品管理局(MHRA)的批准;於2023年1月獲得以色列衞生部藥劑司的批准;於2023年7月獲得加拿大衞生部(HealthCanada)的批准。

近日,公司收到澳大利亞藥物管理局(TGA)簽發的上市許可,這標誌着普利製藥生產的注射用比伐蘆定具備了在澳大利亞上市銷售的資格,將對公司拓展澳大利亞市場帶來積極影響。

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