礼来(LLY.US)FRα ADC获FDA突破性疗法认定_老虎社区_美港股上老虎

礼来(LLY.US)FRα ADC获FDA突破性疗法认定

智通财经01-21

智通财经APP获悉，1月20日，礼来(LLY.US)宣布FDA已授予sofetabart mipitecan(LY4170156)突破性疗法资格，用于治疗既往接受过贝伐珠单抗治疗、且符合用药条件的患者在接受过索米妥昔单抗治疗后的成人铂耐药上皮性卵巢癌、输卵管癌或原发性腹膜癌患者。LY4170156是Mablink Bioscience(已被礼来收购)开发的一款FRα ADC药物，采用自主研发的...

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Bioscience开发的一款FRα ADC药物，采用自主研发的连接子技术，搭载依沙替康作为有效载荷，DAR值为8。FDA此次授予突破性疗法认定是基于LY4170156的Ia/b期研究的积极初步数据。","collect":0,"end_time":0,"defaultTopTitle":"zhitongcaijing.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"SG9999015986.USD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (USD) ACC","LU0266013472.USD":"AXA WF - Framlington Longevity Economy A Cap USD","LU1035775433.USD":"AB SICAV I - AMERICAN GROWTH PORTFOLIO \"AD\" (USD) INC","SG9999017495.SGD":"UGDP UNITED GLOBAL QUALITY GROWTH \"B\" (SGD) ACC","LU0353189680.USD":"富国美国全盘成长基金Cl A Acc","IE00B2B36J28.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I1\" (USD) INC","LU0203201768.USD":"AB SICAV I - ALL MARKET INCOME PORTFOLIO \"AX\" (USD) INC","LLY":"礼来","LU2746668974.SGD":"MANULIFE DYNAMIC LEADERS \"AA\" (SGDHDG) ACC","LU1917777945.USD":"安联专题基金Cl AT Acc","LU1720051017.SGD":"Allianz Global Artificial Intelligence AT Acc H2-SGD","SG9999014914.USD":"UNITED GLOBAL QUALITY GROWTH (USDHDG) INC","LU1804176565.USD":"EASTSPRING INV 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ADC药物，采用自主研发的连接子技术，搭载依沙替康作为有效载荷，DAR值为8。FDA此次授予突破性疗法认定是基于LY4170156的Ia/b期研究的积极初步数据。研究结果显示，该药物在各剂量水平下均能产生疗效，且不受患者FRα表达水平的限制，即便是既往接受索米妥昔单抗治疗后疾病进展的患者，也能从中获益。初步数据还表明，该药物具有良好的耐受性，间质性肺病、周围神经病变、脱发等不良反应发生率较低，且未观察到显著的眼部毒性。","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":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"hasMoreComments":false,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"isCrawlerRequest":true}