康哲藥業(00867.HK)捐贈CytoSorb細胞因子吸附器以救治肺炎重症患者
格隆匯2月19日丨康哲藥業(00867.HK)發佈公告,集團於2020年2月19日與CytoSorbents Corporation簽訂協議,約定將攜手向中國大陸選定醫療機構捐贈首批CytoSorbents的CytoSorb體外細胞因子吸附器,用於臨牀評估其用於重症2019新型冠狀病毒肺炎患者的效果。
CytoSorb已於2012年在歐洲上市銷售,是獲得CE的Ⅱb類醫療設備認證的產品,用於減少由細胞因子和其他炎症介質從而減輕機體系統性過度炎症反應。CytoSorb療法的目標是治療或預防由細胞因子風暴導致的危及生命的併發症,如休克、急性呼吸窘迫綜合徵(ARDS)和其他器官衰竭。CytoSorb在全球58個國家銷售,迄今為止已被用於超過80,000例患者的治療,這些患者包含由細菌和病毒引起的敗血症患者,在一般情況下CytoSorb具有良好的耐受性及安全性。
近期,中國大陸暴發嚴重的2019冠狀病毒疾病(COVID-19),已有多篇醫學文獻表明相當比例的危重COVID-19患者有高炎症反應,在許多情況下,由此產生ARDS、休克和多器官衰竭,從而導致患者預後不良或死亡。
鑑於上述情況,公司與CytoSorbents達成緊急協議,約定攜手聯合捐贈首批特定數量的CytoSorb血液淨化盒給中國大陸選定醫療機構,以支持將CytoSorb用於出現高炎症反應且需要使用體外血液淨化(連續腎臟替代療法(CRRT)/體外膜氧合(ECMO)等)的COVID-19危重患者救治的臨牀評估。
為滿足疫情防控需要,集團將根據中華人民共和國國家藥品監督管理局(NMPA)《關於緊急進口未在中國註冊醫療器械的意見》等相關規定,向有關當局申請緊急進口CytoSorb,以儘快將其捐贈至選定醫療機構。根據臨牀評估的效果,集團可能適時與CytoSorbents展開進一步商業合作。
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