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綠葉製藥(02186.HK)引進的抗腫瘤產品獲准於澳門上市
阿思達克 12-04 12:15
綠葉製藥(02186.HK)公布,公司由PharmaMar許可引進的產品—注射用蘆比替定或LY 01017,已正式獲得澳門藥物監督管理局的上市批准,用於治療接受鉑類藥物化療期間或期後出現疾病進展的轉移性小細胞肺癌(SCLC)成人患者。此外,該產品有望通過粵港澳大灣區的相關政策,惠及更多有需要的SCLC患者,改善他們的生存獲益。 蘆比替定為一種選擇性的致癌基因轉錄抑制劑,獨特的雙重作用機制,使其在抑制腫瘤基因轉錄、導致腫瘤細胞凋亡的同時,還可調節腫瘤微環境,從而進一步發揮抗腫瘤作用。該藥物於2020年獲得美國食品藥品監督管理局(FDA)的附條件批准,是二十多年來唯一獲得FDA批准用於治療復發性SCLC的新分子實體。 除了在澳門地區獲得上市批准,蘆比替定分別在中國內地和香港處於上市審評階段,並被中國國家藥品監督管理局藥品審評中心納入優先審評品種名單。公司將持續推動蘆比替定在中國各大市場的註冊和商業化進程,讓該產品盡快服務臨床急需的患者。(cy/u) ~
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