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遠大醫藥(00512.HK):全球創新放射性核素偶聯藥物TLX591加入國際多中心III期臨牀試驗的申請已獲中國藥監局受理

格隆匯5月7日丨遠大醫藥(00512.HK)公告,集團用於治療前列腺癌的全球創新放射性核素偶聯藥物(RDC)TLX591 (177Lu- HuJ591)加入國際多中心III期臨牀試驗的申請,近日已獲得中國國家藥品監督管理局正式受理,這是集團在覈藥抗腫瘤診療領域的重要研發進展。集團高度重視核藥產業全球化發展戰略,積極推進創新核藥產品的全球化開發及註冊進程,並將持續深化集團核藥產品管線的全球化拓展。

該研究是一項前瞻性、隨機、對照、開放標籤、國際多中心的III期臨牀試驗,擬在中國、美國、澳大利亞、新西蘭等全球多個國家入組500餘名患者,旨在評估TLX591聯合標準治療與僅接受標準治療相比,在既往接受過雄激素受體通路抑制劑(ARPI)治療進展的轉移性去勢抵抗性前列腺癌患者(mCRPC)中的療效和安全性。

集團正在有序推進甲級資質核素生產平臺的建設,並將於本年度正式取得輻射安全許可證投入運營。未來,集團將持續加強核藥抗腫瘤診療板塊的研發和建設,豐富和完善產品管線及產業佈局,形成以易甘泰®釔[90Y]微球注射液爲核心的核藥抗腫瘤診療產品集羣,持續夯實集團在全球核藥抗腫瘤診療領域領軍企業地位。

集團一直高度重視創新產品和先進技術的研發,以患者需求爲核心,以科技創新爲驅動,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,爲全球患者提供更先進更多樣的治療方案。

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