遠大醫藥(00512.HK)：中國藥監局受理SIR-Spheres® 釔[90Y]樹脂微球進口藥品NDA申請
格隆匯 11 月 25日丨遠大醫藥(00512.HK)發佈公告，集團附屬公司遠大醫藥(中國)有限公司及集團聯營公司 Sirtex Medical Pty Ltd正式向中國國家藥品監督管理局提交全球創新產品SIR-Spheres® 釔[90Y]樹脂微球上市許可申請(“NDA”)並獲得正式受理。SIR-Spheres® 釔[90Y]樹脂微球為集團在精準介入治療及放射性核素抗腫瘤藥物的重磅產品之一。
根據披露，SIR-Spheres®釔[90Y]樹脂微球是全球唯一獲得美國食品藥品管理局(“FDA”)正式批准的放射性微球，是一款針對肝臟惡性腫瘤的靶向內放射核素產品，採用全球領先的介入技術將釔[90Y]樹脂微球注入肝臟腫瘤血管，釋放高能量β放射線殺滅腫瘤細胞。
釔[90Y]樹脂微球在歐美及中國香港和中國台灣開展過多項高質量、大樣本量的臨牀研究，臨牀研究證實：釔[90Y]樹脂微球顯著提高腫瘤反應率，使患者腫瘤縮小、降期並重獲肝切除術機會；顯著延長肝臟無進展生存期，控制患者肝臟腫瘤進展，增加等待肝移植手術的時間；同時，釔[90Y]樹脂微球副作用較小、患者生活品質較高。
公告表示，集團將持續佈局抗腫瘤領域，以患者為核心，以科技創新為驅動，加大對放射性藥物和精準介入診療全球創新產品的投入，並聯合美國的OncoSec、澳洲的Sirtex 和 Telix Pharmaceuticals Limited (ASX: TLX)三家全球領先的抗腫瘤醫藥公司，針對尚未滿足的臨牀需求，持續引進不同癌種的全球創新產品，豐富和完善產品管線及產業佈局，致力於打造國際領先的放射性藥物和精準介入診療平台；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，充分發揮集團在國內的產業優勢和研發實力，快速將國際創新產品落地，為中國腫瘤患者提供更先進更多樣的治療方案。
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