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.
翰森製藥(03692.HK):阿美樂一線治療EGFR突變陽性局部晚期或轉移性非小細胞肺癌獲藥品註冊批件
格隆匯 12-16 21:12

格隆匯12月16日丨翰森製藥(03692.HK)公吿,公司附屬公司江蘇豪森藥業集團有限公司研發的1.1類創新藥甲磺酸阿美替尼片(商品名稱阿美樂)用於具有表皮生長因子受體(EGFR)外顯子19缺失或外顯子21(L858R)置換突變陽性的局部晚期或轉移性非小細胞肺癌(NSCLC)成人患者的一線治療適應症已獲得中國國家藥品監督管理局頒發藥品註冊批件。此次為阿美樂獲批的第二個適應症。阿美樂新適應症獲藥品註冊批件將進一步豐富和完善本集團的抗腫瘤產品綫佈局。

阿美樂是一種新型的,不可逆的表皮生長因子受體酪氨酸激酶抑制劑(EGFR-TKI),具有良好的藥學特性可以選擇性的抑制EGFR敏感和耐受突變。阿美樂第一個適應症(即用於既往經EGFR-TKI治療時或治療後出現疾病進展的,存在EGFRT790M突變陽性的局部晚期或轉移性NSCLC成人患者的治療)已於2020年3月獲得國家藥監局藥品註冊批件。此次為阿美樂獲批的第二個適應症(即用於具有EGFR外顯子19缺失或外顯子21(L858R)置換突變陽性的局部晚期或轉移性NSCLC成人患者的一線治療)。

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