
以創新脂質奈米粒平台為核心的TLC-KY今日宣布,旗下子公司台微體已與日本臟器製藥簽訂獨家授權契約,取得長效止痛藥TLC599在日本的獨家開發與商業化權利。
TLC-KY旗下台微體與日本臟器製藥簽訂獨家授權契約,日本臟器取得長效止痛藥TLC599在日本的開發與商業化權利。總金額高達2.03億美元,創下台日生技合作史上最高金額紀錄。
AI-generated summary
TLC-KY以創新脂質奈米粒平台為核心,旗下子公司台微體開發長效止痛藥TLC599。
TLC執行長葉志鴻(資料照)
〔記者陳永吉/台北報導〕以創新脂質奈米粒(LNP)平台為核心的興櫃生技製藥公司TLC-KY(7924)今日與日本製藥公司日本臟器製藥株式會社共同宣布,TLC旗下子公司台微體已與日本臟器簽訂獨家授權契約。依據契約協議,日本臟器取得台微體開發的長效止痛藥TLC599在日本的獨家開發與商業化權利,台微體可取得包含簽約金、開發、法規及銷售里程碑金合計最高達2.03億美元(約新台幣65億元),另於產品上市後依日本地區產品淨銷售額收取最高可達雙位數百分比之分級銷售權利金,創下台日生技合作史上最高金額紀錄。
TLC-KY表示,TLC599為採用TLC專有BioSeizer®脂質技術開發,用於治療膝骨關節炎疼痛之長效型關節腔注射劑。TLC599透過關節腔內注射,旨在延長活性藥物成分於局部的釋放時間,可望為膝骨關節炎疼痛提供新的治療選擇。TLC599 於日本膝骨關節炎患者進行之二期藥物動力學試驗近期已完成收案;於日本及美國進行的三期多區域臨床試驗目前亦持續推進中。
TLC-KY指出,日本臟器製藥株式會社長期深耕疼痛治療,並在骨科及疼痛管理領域從事藥品開發、製造與商業化。透過本次合作,TLC與日本臟器將進一步深化合作關係,共同推進TLC599在日本的開發。
TLC執行長葉志鴻表示:「本次合作是TLC的重要商業里程碑,也印證了我們專有BioSeizer®平台的臨床與商業潛力。日本臟器在日本擁有深厚的商業基礎及疼痛管理領域專業,是拓展TLC599市場可及性的理想合作夥伴。我們期待與日本臟器緊密合作,共同推進TLC599在日本的開發,並儘早將這項極具潛力的治療選擇帶給患者。」
AI outlook — possibilities, not facts
持續推進TLC599在日本及美國的三期多區域臨床試驗
Very likely · Within months

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