遠大醫藥(00512.HK):全球創新型放射性藥物SIR-Spheres®釔[90Y]微球注射液獲批於中國上市
格隆匯2月9日丨遠大醫藥(00512.HK)公吿,集團聯營公司Sirtex的 SIR-Spheres®釔[90Y]微球注射液近日獲得中國國家藥品監督管理局("NMPA")頒發的藥品註冊證書,該藥物在中國獲批的首個適應症為用於經標準治療失敗的不可手術切除的結直腸癌肝轉移患者的治療。
國際癌症研究機構(IARC)最新癌症資料庫數據顯示:2020 年中國結直腸癌新發病例超過 55 萬人,死亡病例超過 28 萬人。"中國結直腸癌肝轉移診斷和綜合治療指南(2020)"顯示:在中國,肝轉移是直接導致結直腸癌患者死亡的重要原因,約 30-50%的結直腸癌患者會發生肝轉移,80-90%的肝轉移灶初始無法獲得根治性切除,肝轉移灶無法切除的患者的 5 年生存率低於10%,而 SIR-Spheres®釔[90Y]微球注射液是中國首個獲得批准用於治療結直腸癌肝轉移灶的產品。
此次SIR-Spheres®釔[90Y]微球注射液的獲批准於中國上市,預期將為中國肝臟惡性腫瘤患者提供一種全新且有效的治療方式,並提供潛在的手術切除機會,彌補了結直腸癌肝轉移局部治療的空白,標誌中國肝臟惡性腫瘤領域迎來了全新國際化精準介入治療方案。
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