药捷安康-B(02617.HK)：替恩戈替尼(TT-00420)被授予治疗MCRPC快速通道认证

格隆汇06-24

格隆汇6月24日丨药捷安康-B(02617.HK)发布公告，美国食品药物管理局(“FDA”)授予替恩戈替尼(tinengotinib, TT-00420)治疗转移性去势抵抗性前列腺癌(“mCRPC”)患者的快速通道认证(fast track designation)。mCRPC是一种晚期前列腺癌，指对去势治疗产生耐药，及╱或出现新转移的前列腺癌。前列腺癌是全球男性死亡率第二高的肿瘤。mCRPC是...

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HK): Tengotinib (TT-00420) was granted MCRPC fast-track certification for treatment","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02617":1,"TT":1,"00420":1},"content_text":"格隆汇6月24日丨药捷安康-B(02617.HK)发布公告，美国食品药物管理局(“FDA”)授予替恩戈替尼(tinengotinib, TT-00420)治疗转移性去势抵抗性前列腺癌(“mCRPC”)患者的快速通道认证(fast track designation)。mCRPC是一种晚期前列腺癌，指对去势治疗产生耐药，及╱或出现新转移的前列腺癌。前列腺癌是全球男性死亡率第二高的肿瘤。mCRPC是导致前列腺癌患者死亡的主要因素。随着人口老龄化，全球mCRPC的发病率从2019年的180,500例上升至2024年的209,300例。替恩戈替尼是一款自主研发、处于全球III期注册实验的多靶点激酶抑制剂，靶向FGFR/VEGFR、JAK和Aurora激酶发挥抗肿瘤作用。目前正在美国与中国进行的临床试验显示，替恩戈替尼在多种实体瘤治疗中具有疗效潜力。替恩戈替尼就治疗CCA获FDA授予孤儿药(ODD)及快速通道认证(FTD)，于中国获国家药品监督管理局突破性疗法认证(BTD)，就治疗胆道癌获EMA孤儿药认证。替恩戈替尼是全球首个和唯一一个有潜力同时抑制FGFR/JAK通路，且针对mCRPC有临床疗效证据的研究药物。于替恩戈替尼单一疗法I期 ╱II期临床试验中，共有13名患者有可测量病灶。整体缓解率(ORR)为46%及疾病控制率(DCR) 为85%。超过90%的患者的肿瘤体积缩小，超过60%的患者肿瘤体积缩小超过 30%。主要结果于2024年ASCO GU公布。作为集团继CCA适应症后获得的第二个快速通道认证，此凸显集团临床与注册团队一贯高效的执行能力，替恩戈替尼的良好疗效数据将支持此药物在mCRPC领域的进一步开发。","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":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"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,"deviceId":"web-server-community-laohu8-v3","version":"4.35.10","shortVersion":"4.35.10","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/2545423968","isCrawlerRequest":true}