和黃醫藥(00013.HK)抑制劑獲納入突破性治療藥物品種
和黃醫藥(00013.HK)公佈,國家藥監局藥品審評中心將HMPL-689納入突破性治療藥物品種,用於治療復發或難治性流泡性淋巴瘤。HMPL-689是一種強效的高選擇性PI3KS抑制劑。
獲納入突破性治療藥物的品種,可在提交新藥上市申請時提出的條件批準申請和優先審評審批申請。此納入或有助加快HMPL-689治療復發或難治性濾泡性淋巴瘤的開發和審評速度,以更快地解決患者未滿足的需求。
和黃醫藥首席執行官Christian Hogg表示,期待HMPL-689下星期在ESMO年會上公佈的重要臨牀數據,並將繼續加快在全球範圍內開發這種創新療法。
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