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.
信達生物(01801.HK):ROS1抑制劑達伯樂(己二酸他雷替尼膠囊)獲國家藥品監督管理局批准上市
格隆匯 12-20 19:16

格隆匯12月20日丨信達生物(01801.HK)公吿,新一代ROS1酪氨酸激酶抑制劑(TKI)達伯樂(己二酸他雷替尼膠囊)的新藥上市申請(NDA)獲中國國家藥品監督管理局(NMPA)批准上市,用於經ROS1-TKI治療後進展的ROS1陽性局部晚期或轉移性非小細胞肺癌(NSCLC)成人患者的治療。

達伯樂是公司第13款商業化產品,這一創新精準療法將惠及ROS1突變的肺癌患者,並進一步加強公司在腫瘤精準治療領域的品牌和產品組合優勢。本次獲批是基於一項臨牀II期研究TRUST-I (NCT04395677)的積極結果。該試驗是一項在中國開展的多中心、開放標籤、單臂試驗,旨在評估達伯樂在中國ROS1陽性NSCLC患者中的安全性、耐受性和療效。TRUST-I臨牀研究的結果於美國《臨牀腫瘤學雜誌》(Journal of Clinical Oncology, JCO)發表,並在2024年美國臨牀腫瘤學會(ASCO)年會上以口頭報吿的形式展示。臨牀結果提示,特別在ROS1抑制劑經治的患者中,達伯樂充分展現了對這一未滿足需求的治療潛力。

達伯樂是一種口服、強效、腦滲透、選擇性、新一代潛在最佳的ROS1抑制劑。他雷替尼正在兩項2期臨牀研究中評估在ROS1陽性NSCLC患者中的作用,分別是在中國開展的臨牀研究TRUST-I (NCT04395677)和全球關鍵臨牀研究TRUST-II(NCT04919811)。

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