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中國同輻(01763.HK):中核高通首批GMP級氯化鑥(177Lu)溶液順利供應市場
格隆匯 12-08 18:59

格隆匯12月8日丨中國同輻(01763.HK)發佈公吿,於2020年12月6日,公司所屬成都中核高通同位素股份有限公司首批GMP級氯化(177Lu)溶液順利供應科研院所、醫療機構開展藥物及臨牀應用研究。

中核高通與德國ITM公司(IsotopenTechnologienMünchenAG)自2019年合作以來,在生產線準備、質量管理體系建設、分析測試方法及工藝驗證、設備確認等方面均取得了突破性成果,三批試製產品全部符合歐盟原料藥質量標準要求。首批氯化(177Lu)溶液發往16家用户進行藥物研發及臨牀研究工作,邁出符合GMP要求的177Lu核素國產化生產第一步,為促進我國核技術應用產業高質量發展貢獻力量。

放射性核素177Lu憑藉優良的核素性質,已成為目前最具市場前景的靶向放射性治療核素,其標記藥物可用於神經內分泌腫瘤、前列腺癌、乳腺癌等疾病的靶向放射性治療。在全球範圍內,已批准上市的177Lu標記藥物在臨牀應用研究中均取得了顯著療效。

未來,中核高通將按計劃穩定供應GMP級氯化(177Lu)溶液,積極推進我國新一代放射性診療藥物研發及臨牀應用,為癌症患者提供靶向放射性核素治療(TRT)新選擇,共同改善患者預後生活質量,積極踐行責任、安全、創新、協同的企業核心價值觀,推進健康中國戰略落地。

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