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Telix公司稱,其膠質瘤成像候選藥物的上市許可申請已獲歐洲審查委員會受理;股價上漲3%。

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-- Telix Pharmaceuticals(ASX:TLX)週五宣布,其膠質瘤成像候選藥物TLX101-Px在歐洲提交的上市許可申請已獲驗證並被受理,進入為期210天的積極評估階段。 該公司在聲明中表示,正在尋求符合當前臨床實踐指南的廣泛臨床適應症,預計在第210天取得積極結果後,將很快獲得各國的上市許可。 該公司表示,其目標是擴大患者獲得先進影像技術的機會,該技術能夠區分成人和兒童的進展性或復發性膠質瘤與治療相關變化,並有可能在未來開發出其他適應症。 聲明也指出,TLX101-Px同時也被開發為Telix膠質母細胞瘤治療候選藥物TLX101-Tx的病患選擇和療效評估工具。 TLX101-Tx已在歐洲和美國取得孤兒藥資格認定。 該公司表示,TLX101-Tx治療復發性膠質母細胞瘤患者的III期IPAX-BrIGHT試驗已在全球範圍內啟動患者給藥,並將在多個歐洲國家進行。 Telix Pharmaceuticals的股價在上週五的交易中上漲了3%。

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