雲頂新耀(01952.HK):Nefecon獲南韓納入快速通道審批品種
雲頂新耀(01952.HK)宣佈,口服靶向布地奈德遲釋膠囊Nefecon近日獲南韓食品醫藥品安全部納入全球創新產品快速通道計劃,用於治療原發性IgA腎病。此前中國國家藥品監督管理局亦已將Nefecon納入優先審評。
雲頂新耀首席執行官羅永慶表示,IgA腎病在東亞的發病率遠高於世界其他地區,希望儘快將該創新療法帶給該地區的患者,以滿足患者的醫療需求。
雲頂新耀於2019年與Calliditas簽訂獨家授權許可協議,獲得在大中華地區和新加坡開發以及商業化Nefecon的權利。該協議於2022年3月擴展,將南韓納入雲頂新耀的授權許可範圍。
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