遠大醫藥(00512.HK):全球創新放射性核素偶聯藥物TLX101的中國臨牀試驗申請獲藥監局受理
格隆匯2月5日丨遠大醫藥(00512.HK)董事會欣然公吿,集團用於治療多形性膠質母細胞瘤的全球創新放射性核素偶聯藥物(“RDC”) TLX101的新藥臨牀試驗(“IND”)申請,近日已獲得中華人民共和國國家藥品監督管理局(“藥監局”)正式受理,是集團在核藥抗腫瘤診療領域的重要研發進展。
TLX101 (131I-IPA)是一種基於放射性核素-小分子偶聯技術用於治療多形性膠質母細胞瘤的治療性放射性藥物,可自由通過血腦屏障進入大腦,並靶向膠質母細胞瘤過度表達的L型氨基酸轉運蛋白1 (LAT-1)精準輻射癌細胞,促使其凋亡以達到治療效果。TLX101已獲美國食品藥品監督管理局(FDA)孤兒藥認定,在歐洲和澳洲開展的I/II期臨牀試驗也在順利進行中。膠質母細胞瘤是僅次於腦膜瘤的第二最常見的腦腫瘤,年發病率約為3.2/10萬,5年存活期僅5%。目前臨牀上現有的治療手段僅能延緩腫瘤的進展,但無法避免腫瘤的復發,治療效果並不理想。TLX101有望成為膠質母細胞瘤治療領域中的一種開拓性的治療手段。
圍繞腫瘤診療一體化的治療理念,集團核藥抗腫瘤診療板塊目前已儲備13款創新產品(其中三款產品的IND申請已獲得藥監局受理),涵蓋68Ga、177Lu、131I、90Y、89Zr、99mTc在內的6种放射性核素,覆蓋了肝癌、前列腺癌、腦癌等在內的8個癌種;在產品種類方面,涵蓋診斷和治療兩類核素藥物,為患者提供多適應症治療選擇、多手段且診療一體化的全球領先的抗腫瘤方案。
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