迪哲醫藥(688192.SH):舒沃哲®一線治療 EGFR 20 號外顯子插入突 變的晚期非小細胞肺癌獲得 CDE 突破性療法認定
格隆匯10月13日丨迪哲醫藥(688192.SH)公佈,國家藥品監督管理局藥品審評中心(以下簡稱“CDE”)授予公司首款自主研發的新型肺癌靶向藥舒沃哲®(通用名:舒沃替尼片)突破性療法認定(Breakthrough
Therapy Designation, BTD),用於未接受過系統性治療、攜帶表皮生長因子受體(EGFR)20
號外顯子插入突變(Exon20ins)的局部進展或轉移性非小細胞肺癌(NSCLC)。
舒沃哲®是肺癌領域首個獲中、美兩國雙
BTD 資格的國產創新藥,用於二/ 後線治療 EGFR Exon20ins NSCLC。今年 4 月,舒沃哲®一線治療該適應症獲美國食品藥品管理局(FDA)授予
BTD,此次一線治療再獲 CDE 認定,舒沃哲®成為首個且唯一全線治療 EGFR Exon20ins NSCLC 獲四項中、美“突破性療法認定”的創新藥物。
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.