亚虹医药(688176.SH)：APL-2401在澳大利亚获得开展Ⅰ期临床试验许可

智通财经01-22

智通财经APP讯，亚虹医药(688176.SH)发布公告，近日，公司子公司Asieris Pharmaceuticals (Aus) Pty Ltd收到澳大利亚人类研究伦理委员会签发的关于批准公司开发的产品APL-2401(药物名称为ASN-8639片)在FGFR2/3驱动的晚期实体瘤患者中开展Ⅰ期临床试验的临床试验伦理许可，并于澳大利亚卫生部所属的Therapeutic Goods ...

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SH): APL-2401 obtained license to conduct phase I clinical trials in Australia","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"688176":1.5},"content_text":"智通财经APP讯，亚虹医药(688176.SH)发布公告，近日，公司子公司Asieris Pharmaceuticals (Aus) Pty Ltd收到澳大利亚人类研究伦理委员会签发的关于批准公司开发的产品APL-2401(药物名称为ASN-8639片)在FGFR2/3驱动的晚期实体瘤患者中开展Ⅰ期临床试验的临床试验伦理许可，并于澳大利亚卫生部所属的Therapeutic Goods Administration(即澳大利亚药品管理局)完成临床试验备案。按照澳大利亚药品注册相关法律法规，公司已获得该产品I期临床试验许可。此前APL-2401临床试验申请已获得国家药品监督管理局批准，公司将积极推进该产品的国际多中心临床研究。APL-2401是公司自主研发的高选择性成纤维生长因子受体2/3(FGFR2/3)双靶点小分子抑制剂，有望为晚期实体瘤(例如：尿路上皮癌、胆管癌、子宫内膜癌、胃癌、乳腺癌、卵巢癌、非小细胞肺癌和其他特定实体瘤)患者提供一种新的治疗选择。公司通过TAIDD平台进行靶点多构象模拟，并以其选择性机制作为苗头化合物发现和设计为核心，从而优化出最终的临床前候选化合物APL-2401。 APL-2401是一款通过非共价结合模式与靶点相结合的高选择性的FGFR2/3小分子抑制剂。相比现阶段FGFR2或FGFR3选择性抑制剂，APL-2401体现出卓越的双重激酶抑制活性，肿瘤细胞杀伤及调节肿瘤微环境的效果;相比pan-FGFR 抑制剂，APL-2401显著降低了FGFR1和FGFR4相关的毒副作用。临床前实验表明APL-2401在多种FGFR2/3基因突变，扩增或过表达模型中展现出优异的疗效和更宽的安全窗。与现有同类产品相比，APL-2401在活性、选择性、安全性和成药性方面均显示出潜在的同类最佳优势，有望成为FGFR2/3靶向治疗领域的重磅产品。","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,"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":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,"tenantId":"TBCN","deviceId":"web-server-community-laohu8-v3","version":"4.42.0","shortVersion":"4.42.0","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/2605461931","isCrawlerRequest":true}