石藥康寧傑瑞ADC獲突破性認定針對結直腸癌；Cogent新藥獲FDA突破性認定；GSK口服抗生素3期達效擬年內申報上市

藥財社

10/22

●藥聞快報▲關注藥財社聚焦醫藥界▲1石藥康寧傑瑞ADC獲突破性認定針對結直腸癌10月20日石藥集團宣佈，其與康寧傑瑞合作開發的HER2雙特異性ADC藥物JSKN003又一次次獲得CDE授予的突破性療法認定。適應症為單藥用於治療既往經奧沙利鉑、氟尿嘧啶和伊立替康治療失敗的HER2陽性晚期結直腸癌（CRC）。JSKN003是一種靶向HER2雙表位ADC，通過糖基定點偶聯將TOPO1抑制劑連接至抗體...

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18:01</span>\n</p>\n</h4>\n</header>\n<article>\n<div>\n<p>●藥聞快報▲關注藥財社聚焦醫藥界▲1石藥康寧傑瑞ADC獲突破性認定針對結直腸癌10月20日石藥集團宣佈，其與康寧傑瑞合作開發的HER2雙特異性ADC藥物JSKN003又一次次獲得CDE授予的突破性療法認定。適應症為單藥用於治療既往經奧沙利鉑、氟尿嘧啶和伊立替康治療失敗的HER2陽性晚期結直腸癌（CRC）。JSKN003是一種靶向HER2雙表位ADC，通過糖基定點偶聯將TOPO1抑制劑連接至抗體...</p>\n\n<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251022182935a46e5204&s=b\">網頁鏈接</a>\n\n</div>\n\n<div class=\"bt-text\">\n\n\n<p> 來源：<a href=\"http://gu.qq.com/resources/shy/news/detail-v2/index.html#/?id=nesSN20251022182935a46e5204&s=b\">藥財社</a></p>\n<p>為提升您的閱讀體驗，我們對本頁面進行了排版優化</p>\n\n\n</div>\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":"●藥聞快報▲關注藥財社聚焦醫藥界▲1石藥康寧傑瑞ADC獲突破性認定針對結直腸癌10月20日石藥集團宣佈，其與康寧傑瑞合作開發的HER2雙特異性ADC藥物JSKN003又一次次獲得CDE授予的突破性療法認定。適應症為單藥用於治療既往經奧沙利鉑、氟尿嘧啶和伊立替康治療失敗的HER2陽性晚期結直腸癌（CRC）。JSKN003是一種靶向HER2雙表位ADC，通過糖基定點偶聯將TOPO1抑制劑連接至抗體KN026（重組人源化抗HER2雙特異性抗體）的N糖基化位點處。點擊反應偶聯物較馬來酰亞胺－邁克爾反應的偶聯物具有更好的血清穩定性。雙表位HER2靶向性使JSKN003具有更強的內吞誘導及旁觀者殺傷效應，使其在HER2表達腫瘤中具有較強的抗腫瘤活性。2Cogent新藥獲FDA突破性認定Cogent Biosciences日前宣佈，美國FDA授予其在研小分子bezuclastinib突破性療法認定。用於此前接受avapritinib治療的非晚期系統性肥大細胞增多症（NonAdvSM）以及冒煙型系統性肥大細胞增多症患者。這些患者目前尚無獲批的標準治療方案。公司計劃據此加速推進後續上市申請進程。Bezuclastinib是一款選擇性受體酪氨酸激酶抑制劑，設計用以靶向KIT D816V突變，以及靶向KIT在外顯子17上的其他突變。3GSK口服抗生素3期達效擬年內申報上市今日，GSK與Spero Therapeutics聯合公佈了關鍵性3期PIVOT-PO研究的完整積極結果。該研究評估了口服在研藥物tebipenem HBr用於治療複雜性尿路感染（cUTI），包括腎盂腎炎的療效與安全性。研究結果顯示，tebipenem 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