甲磺酸艾多替尼片(TY-9591)提交Pre-NDA申请

智通财经2025-04-24

智通财经APP获悉，同源康医药(股票代码：02410)今日宣布，已于近日向国家药品监督管理局药品审评中心(CDE)提交了其在研1类新药甲磺酸艾多替尼片(TY-9591)的Pre-NDA申请，该药有望成为全球首款针对非小细胞肺癌(NSCLC)脑转移患者的第三代EGFR -TKI。本次Pre-NDA申请是基于TYKM1601202研究(ESAONA)的卓越结果。该研究是一项前瞻性、多中心、随机、活性...

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Barnholtz-Sloan JS, Sloan AE, Davis FG, et al. Incidence proportions of brain metastases in patients diagnosed (1973 to 2001) in the Metropolitan Detroit Cancer Surveillance System. J Clin Oncol. 2004;22(14):2865-2872. doi:10.1200/JCO.2004.12.149.2. London D, Patel DN, Donahue B, et al. The incidence and predictors of new brain metastases in patients with non-small cell lung cancer following discontinuation of systemic therapy. J Neurosurg. 2021;137(2):544-554. doi:10.3171/2021.9.JNS212150.3. Kim M, Suh CH, Lee SM, et al. Diagnostic Yield of Staging Brain MRI in Patients with Newly Diagnosed Non-Small Cell Lung Cancer. Radiology. 2020;297(2):419-427. doi:10.1148/radiol.2020201194.4. Zhao W, Zhou W, Rong L, et al. Epidermal growth factor receptor mutations and brain metastases in non-small cell lung cancer. Front Oncol. 2022;12:912505. doi:10.3389/fonc.2022.912505.5. Ouyang W, Yu J, Zhou Y, et al. Risk factors of metachronous brain metastasis in patients with EGFR-mutated advanced non-small cell lung cancer. BMC Cancer. 2020;20(1):699. doi:10.1186/s12885-020-07202-8.6. Sperduto PW, Mesko S, Li J, et al. Survival in Patients With Brain Metastases: Summary Report on the Updated Diagnosis-Specific Graded Prognostic Assessment and Definition of the Eligibility Quotient. J Clin Oncol. 2020;38(32):3773-3784. doi:10.1200/JCO.20.01255.","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":1,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":false,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.40.0","shortVersion":"4.40.0","platform":"web","vendor":"web","appName":"laohu8","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2529616793","isCrawlerRequest":true}