遠大醫藥(00512.HK)獲批中國市場首款雙適應症創新冠脈介入治療藥物球囊產品醫療器械註冊證
格隆匯10月14日丨遠大醫藥(00512.HK)發佈公告，由集團及位於德國的聯營公司Cardionovum GmbH (“Cardionovum”)共同自主開發的中國市場首款同時具有支架內再狹窄( “ISR”) 和小血管病變(“SVD”)的雙適應症的創新冠脈介入治療產品“紫杉醇釋放冠脈球囊擴張導管”(商品名：RESTORE DEB Paclitaxel Releasing PTCA Balloon Catheter)(為一款藥物塗層球囊產品) (“RESTORE DEB”)，已於近日獲批國家藥品監督管理局頒發的“醫療器械註冊證”，並將會由集團負責於中國的推廣和銷售。
RESTORE DEB為自研藥物塗層球囊產品，採用獨有的SAFEPAX專利塗層技術，可減少導管送達病變過程中，球囊表面藥物被血液沖刷流失，提高藥物到達靶病變部位的比率，同時減少冠脈血管遠端微栓塞及痙攣風險，而且因為RESTORE DEB採用極小的紫杉醇藥物粒徑，可使病變目標獲得更佳的組織吸收，發揮更持久的藥物作用，從而提升臨牀有效性。
作為心血管權威專家期待的冠心病經皮冠狀動脈介入治療(PCI治療)原創產品之一，RESTORE DEB獲批後將成為目前中國市場首款及唯一一款具有支架內再狹窄和小血管病變的雙適應症產品，擁有廣闊的臨牀價值和市場前景。
公告表示，本次RESTORE DEB產品取得“醫療器械註冊證”，代表集團具備於中國銷售或分銷該產品的資格，有望與集團在心血管領域的優勢產生積極的協同作用。集團會充分發揮在心血管領域的資源優勢，積極推動該創新產品的上市銷售，同時籍以豐富集團的醫療器械產品種類，提高市場競爭力。
此外，集團另外兩款創新自研藥物塗層球囊產品Aperto及Legflow中國的臨牀研究和註冊進程也在積極推進中，上市後將豐富集團在血管介入領域內的產品管線。集團將持續在醫療器械領域(特別是創新、原研的產品)積極拓展，為醫生和患者提供更多的臨牀選擇。
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.
