四環醫藥(00460.HK)：吡洛西利片聯合芳香化酶抑制劑一線治療HR+╱HER2-晚期乳腺癌新適應症NDA獲NMPA受 理
格隆匯6月9日丨四環醫藥(00460.HK)宣佈，集團旗下非全資附屬公司軒竹生物自主研發的1類創新藥吡洛西利片(商品名：軒悦寧®)新增適應症的新藥上市申請("NDA")獲得中國國家藥品監督管理局("NMPA")受理，具體適應症為：與芳香化酶抑制劑聯用作為激素受體陽性(HR+)、人表皮生長因數受體2陰性(HER2-)("HR+/HER2-")晚期乳腺癌患者的初始內分泌治療，以及經他莫昔芬或託瑞米芬輔助治療後進展患者的後續治療。是該產品申報NDA的第3項適應症。
吡洛西利是軒竹生物自主研發的一款CDK4/6(細胞週期依賴性激酶4和6)抑制劑，憑藉其獨特的CDK2/4/6/9多靶點協同作用機制，在強效抑制腫瘤細胞增殖的同時，顯着降低傳統CDK4/6抑制劑常見的3/4級中性粒細胞減少等血液學毒性，提升患者治療耐受性。此前已獲批聯合氟維司羣二線內分泌治療及單藥後線治療兩大適應症，未來該產品將覆蓋HR+/HER2-晚期乳腺癌患者的一線、二線、後線治療的全部人羣，將進一步完善乳腺癌全程管理佈局，為國內患者提供更精準的治療選擇。
乳腺癌為全球女性發病率最高的惡性腫瘤，根據國際癌症研究機構(IARC)於二零二五年在《Nature Medicine》雜誌上發佈的最新數據，二零二二年全球乳腺癌新發病例230萬例，預計到二零五零年新發病例將達到320萬例，其中，約70%乳腺癌患者為HR+/HER2-亞型，具有龐大的治療需求。二零二四年全球CDK4/6抑制劑藥物市場規模近130億美元，同比增長約18%。
吡洛西利此次新適應症NDA獲受理，不僅是本集團創新研發實力的有力證明，也意味着我們在為乳腺癌患者提供更有效治療方案的道路上又邁出了堅實一步。未來，四環醫藥將繼續秉承創新驅動的發展理念，加大研發投入，加速創新成果轉化，為全球患者的健康福祉貢獻更多力量。
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