石药康宁杰瑞ADC获突破性认定针对结直肠癌；Cogent新药获FDA突破性认定；GSK口服抗生素3期达效拟年内申报上市

药财社

10/22

●药闻快报▲关注药财社聚焦医药界▲1石药康宁杰瑞ADC获突破性认定针对结直肠癌10月20日石药集团宣布，其与康宁杰瑞合作开发的HER2双特异性ADC药物JSKN003又一次次获得CDE授予的突破性疗法认定。适应症为单药用于治疗既往经奥沙利铂、氟尿嘧啶和伊立替康治疗失败的HER2阳性晚期结直肠癌（CRC）。JSKN003是一种靶向HER2双表位ADC，通过糖基定点偶联将TOPO1抑制剂连接至抗体...

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href=http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251022182935a46e5204&s=b><strong>药财社</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>●药闻快报▲关注药财社聚焦医药界▲1石药康宁杰瑞ADC获突破性认定针对结直肠癌10月20日石药集团宣布，其与康宁杰瑞合作开发的HER2双特异性ADC药物JSKN003又一次次获得CDE授予的突破性疗法认定。适应症为单药用于治疗既往经奥沙利铂、氟尿嘧啶和伊立替康治疗失败的HER2阳性晚期结直肠癌（CRC）。JSKN003是一种靶向HER2双表位ADC，通过糖基定点偶联将TOPO1抑制剂连接至抗体...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251022182935a46e5204&s=b\">网页链接</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU1226287792.SGD","symbol_name":"UBS (LUX) KEY SEL S-CHINA ALLOCATION OPP \"P\" (SGDHDG) 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year","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"01093":1.5},"content_text":"●药闻快报▲关注药财社聚焦医药界▲1石药康宁杰瑞ADC获突破性认定针对结直肠癌10月20日石药集团宣布，其与康宁杰瑞合作开发的HER2双特异性ADC药物JSKN003又一次次获得CDE授予的突破性疗法认定。适应症为单药用于治疗既往经奥沙利铂、氟尿嘧啶和伊立替康治疗失败的HER2阳性晚期结直肠癌（CRC）。JSKN003是一种靶向HER2双表位ADC，通过糖基定点偶联将TOPO1抑制剂连接至抗体KN026（重组人源化抗HER2双特异性抗体）的N糖基化位点处。点击反应偶联物较马来酰亚胺－迈克尔反应的偶联物具有更好的血清稳定性。双表位HER2靶向性使JSKN003具有更强的内吞诱导及旁观者杀伤效应，使其在HER2表达肿瘤中具有较强的抗肿瘤活性。2Cogent新药获FDA突破性认定Cogent Biosciences日前宣布，美国FDA授予其在研小分子bezuclastinib突破性疗法认定。用于此前接受avapritinib治疗的非晚期系统性肥大细胞增多症（NonAdvSM）以及冒烟型系统性肥大细胞增多症患者。这些患者目前尚无获批的标准治疗方案。公司计划据此加速推进后续上市申请进程。Bezuclastinib是一款选择性受体酪氨酸激酶抑制剂，设计用以靶向KIT D816V突变，以及靶向KIT在外显子17上的其他突变。3GSK口服抗生素3期达效拟年内申报上市今日，GSK与Spero Therapeutics联合公布了关键性3期PIVOT-PO研究的完整积极结果。该研究评估了口服在研药物tebipenem HBr用于治疗复杂性尿路感染（cUTI），包括肾盂肾炎的疗效与安全性。研究结果显示，tebipenem HBr达到了主要终点，与静脉给药方案相比表现出非劣效性。相关数据将提交至监管机构，以支持后续的上市申请。","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":1,"need_auth":false,"code":"91000000","status":"200"}}}