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遠大醫藥(00512.HK):創新放射性核素偶聯藥物TLX591-CDx中國III期臨牀研究完成全部患者入組給藥並計劃今年內遞交上市申請
格隆匯 05-12 19:29

格隆匯5月12日丨遠大醫藥(00512.HK)發佈公吿,集團用於診斷前列腺癌的創新在研放射性核素偶聯藥物(RDC)TLX591-CDx (Illuccix, gallium Ga 68 PSMA-11)在中國進行的 III 期臨牀試驗,近日已完成全部患者入組給藥,並計劃於今年內在中國遞交新藥上市申請,這是集團在核藥抗腫瘤診療領域的又一次重要研發進展。

該研究是一項單臂、開放標籤的 III 期臨牀研究,擬在超過100例前列腺癌生化復發患者中使用TLX591-CDx並進行正電子發射斷層成像/電腦斷層掃描(PET/CT)或正電子發射斷層成像/磁共振成像(PET/MRI)檢測,以評估產品的診斷有效性,同時評估產品在中國人羣中的安全性和耐受性。集團享有該產品在中國大陸、香港特別行政區、澳門特別行政區及台灣地區的獨家開發及商業化權益。

TLX591-CDx是一款全球創新、基於放射性核素-小分子偶聯技術的靶向前列腺特異性膜抗原(PSMA)的診斷型放射性藥物,適用於轉移性前列腺癌及複發性前列腺癌的診斷。基於公開數據,TLX591-CDx中的靶向劑PSMA-11能以高親和力的方式特異性結合在前列腺癌中高表達的PSMA上,具有可內化入細胞、生物學活性穩定、體內循環半衰期短以及對腫瘤實質的滲透性好且可被非靶向組織快速清除的五大特點。

集團一直高度重視創新產品和先進技術的研發,以患者需求為核心,以科技創新為驅動,針對尚未滿足的臨牀需求,加大對全球創新產品和先進技術的投入,豐富和完善產品管線及產業佈局,採用「全球化運營佈局,雙循環經營發展」策略,形成國內國際雙循環聯動發展並相互促進的新格局,充分發揮集團的產業優勢和研發實力,快速將科技創新產品落地上市,為全球患者提供更先進更多樣的治療方案。

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