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通化金馬:新藥審評(píng)按CDE工作流程已經(jīng)處于臨近審批階段

2025-08-07 19:46  來源:證券日?qǐng)?bào)網(wǎng) 

    證券日?qǐng)?bào)網(wǎng)訊 ?通化金馬8月7日在互動(dòng)平臺(tái)回答投資者提問時(shí)表示,公司的新藥審評(píng)按CDE工作流程已經(jīng)處于臨近審批階段。提問信息所涉及到的臨床試驗(yàn)不是用于補(bǔ)充III期臨床試驗(yàn)數(shù)據(jù),而是公司處于對(duì)新藥未來市場(chǎng)的判斷及國際化的戰(zhàn)略規(guī)劃,從深度研發(fā)、擴(kuò)大適應(yīng)癥等方面,積極籌備IV期臨床試驗(yàn),不影響目前新藥綜合審評(píng)的推動(dòng)進(jìn)程。有關(guān)新藥的信息公司將根據(jù)有關(guān)規(guī)定和要求予以披露。

(編輯 王雪兒)

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