遠大醫藥(00512.HK)：全球創新放射性核素偶聯藥物TLX591-CDx於美國獲批上市
格隆匯12月21日丨遠大醫藥(00512.HK)公吿，集團在放射性核素偶聯藥物("RDC")領域的重要戰略合作伙伴 TelixPharmaceuticals Limited (ASX: TLX，集團持股約7.35%)用於前列腺癌診斷成像的全球創新型 RDC 藥物 TLX591-CDx (Illuccix®, 68Ga-HBED-CC-PSMA11)近日正式獲得美國食品藥品監督管理局(Food and Drug Administration，"FDA")的上市許可。
TLX591-CDx 是一款全球創新、基於放射性核素-抗體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。TLX591-CDx 中的靶向劑 PSMA11 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。此前，該產品於今年 11 月在澳大利亞獲批上市並於 12 月初在巴西獲得特別授權，准許正式獲批前銷售。臨牀研究方面，TLX591-CDx 於今年 6 月在日本開展的臨牀研究將會為產品在中國的註冊積累亞洲人羣的安全性資料，該項目中國的註冊工作正穩步推進，預計將於 2022 年第一季度向中國國家藥品監督管理局(NMPA)遞交臨牀研究申請(IND)。TLX591-CDx 在歐盟和加拿大的上市申請也在積極推進過程中。此次獲得 FDA 的上市許可將進一步為該產品在中國註冊落地奠定堅實的基礎。
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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