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.
華大基因(300676.SZ):全資子公司腸癌檢測產品獲得沙特FDA批准上市
格隆匯 01-07 11:48

格隆匯1月7日丨華大基因(300676.SZ)公佈,公司全資子公司BGI Europe A/S(簡稱”歐洲醫學“)的腸癌輔助診斷產品於近日獲得Saudi Food & Drug Authority(英文簡稱”SFDA“,中文譯名”沙特阿拉伯食品藥品管理局“)批准上市。

公司此次獲得SFDA批准的檢測產品,是針對人糞便樣本人源基因組中與結直腸癌發生發展相關的甲基化標誌物進行檢測,適用於臨牀結直腸癌的輔助診斷,具有較高的靈敏度;該檢測產品可實現自採樣,方便快捷的取樣方式及其非侵入性的特徵,有助於提升沙特本地腸癌診斷能力。

歐洲醫學的腸癌檢測產品符合沙特阿拉伯醫療器械臨時條例(Medicaldevices interim regulation, MDIR)及醫療器械銷售授權(Medical Device Marketing Authorisation, MDMA)實施規則的規定及要求,獲得SFDA批准上市,具備了在沙特阿拉伯進行銷售的准入資質。

上述產品獲得SFDA批准上市,進一步擴大了公司在沙特乃至整個中東地區的影響力和業務範圍,以期助力區域腫瘤防控工作,為長期本地化發展與合作奠定基礎。此外,該次註冊獲批是公司深入拓展國際佈局,實現海外業務可持續發展的又一重要成果,有利於加速提升公司全球市場份額,進一步加強公司產品的國際競爭力。

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