東曜藥業-B(01875.HK)替莫唑胺膠囊獲批上市
格隆匯5月31日丨東曜藥業-B(01875.HK)宣佈,公司自主研發的替莫唑胺膠囊(TOZ309,擬使用商標名稱為“替至安®(Tazian®)”)(“該產品”)已獲得國家藥品監督管理局(“NMPA”)藥品註冊批件。該產品為視同通過質量和療效一致性評價的仿製藥,可在中國境內(即不包括香港、澳門和台灣地區)上市,用於治療:(1)新診斷的多形性膠質母細胞瘤,開始先與放射治療聯合治療,隨後作為維持治療;及(2)常規治療後復發或進展的多形性膠質母細胞瘤或間變性星形細胞瘤。
該產品是按照NMPA化學藥品新4類仿製藥申請上市,其規格包括20mgⅹ5粒╱瓶和100mgⅹ5粒╱瓶。
TOZ309替至安®是替莫唑胺膠囊“泰道®(TEMODAR®)”的仿製藥。替莫唑胺為咪唑並四嗪類具有抗腫瘤活性的烷化劑,可通過破壞DNA殺死癌細胞。與常規化化療相比,隨着療效加強及副作用減少,替莫唑胺膠囊被用作新診斷及複發性腦膠質瘤的一線藥物。
中國境內市場上僅有三款替莫唑胺膠囊,包括原研藥“泰道®(TEMODAR®)”,其已於1999年獲美國藥品監督管理局批准,並於2007年獲NMPA批准進入中國市場。根據弗若斯特沙利文的資料,替莫唑胺膠囊在中國境內市場的銷售額於2018年達到人民幣約18億元,預期於2023年將增至人民幣約25億元。
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.