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信達生物(01801.HK)IBI343治療晚期胃癌新藥上市申請獲國家藥監局受理
信達生物(01801.HK)公布，IBI343用於晚期胃癌人群的國際III期臨床研究(G-HOPE-001,NCT06238843)按預設方案完成第一次期中分析，達到主要研究終點。基於這個積極的臨床結果，公司已向中國國家藥品監督管理局遞交IBI343的新藥上市申請。該申請已獲受理並予以優先審評，用於至少接受過兩種系統性治療的局部晚期不可切除或轉移性CLDN1...
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信達生物(01801.HK)IBI343治療晚期胃癌新藥上市申請獲國家藥監局受理
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信達生物(01801.HK)  +0.200 (+0.262%)    Short selling $414.90M; Ratio 35.508%   公布，IBI343用於晚期胃癌人群的國際III期臨床研究(G-HOPE-001,NCT06238843)按預設方案完成第一次期中分析，達到主要研究終點。基於這個積極的臨床結果，公司已向中國國家藥品監督管理局遞交IBI343的新藥上市申請。該申請已獲受理並予以優先審評，用於至少接受過兩種系統性治療的局部晚期不可切除或轉移性CLDN18.2陽性胃或胃食管結合部腺癌。

IBI343是全球首個獲監管審評受理的CLDN18.2靶向ADC藥物。(sl/a)(HK stocks quote is delayed for at least 15 mins.Short Selling Data as at 2026-06-05 16:25.)

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