四環醫藥(00460.HK)：軒竹生物自主研發的1類創新藥吡洛西利片單藥及聯合氟維司羣治療HR+╱HER2－晚期乳腺癌的兩個適應症獲國家藥監局上市批準
格隆匯5月15日丨四環醫藥(00460.HK)公告，集團旗下非全資附屬公司軒竹生物科技股份有限公司（軒竹生物）自主研發的CDK4/6（細胞週期依賴性激酶4和6）抑制劑1類新藥吡洛西利片（曾用名「吡羅西尼」，XZP-3287，商品名：軒悅寧）2個適應症的新藥上市申請(NDA)獲得中國國家藥品監督管理局頒發的藥品註冊批件。具體爲：(1)單藥用於既往轉移性階段接受過兩種及以上內分泌治療和一種化療後出現疾病進展的激素受體陽性（HR+）、人表皮生長因子受體2陰性（HER2-）的晚期或轉移性乳腺癌成人患者；(2)與氟維司羣聯合用於既往接受內分泌治療後出現疾病進展的HR+、HER2-晚期或轉移性乳腺癌成人患者。
吡洛西利片爲國內唯一獲批單藥用於HR+╱HER2-晚期乳腺癌後線治療的CDK4/6抑制劑，也是軒竹生物首個獲批上市的抗腫瘤創新藥。針對我國乳腺癌患者發病特點，吡洛西利臨牀試驗數據具有顯著臨牀價值。研究數據顯示，我國乳腺癌患者中位發病年齡較西方國家更早，Luminal B型腫瘤、原發耐藥及化療人羣比例更高，預後相對較差。本項臨牀研究精準匹配中國治療現狀：研究組中既往接受晚期化療的患者佔比23.9%，原發耐藥患者25.6%，絕經前患者37%，內臟轉移患者68.2%。聯合氟維司羣用藥使二線治療患者的中位無進展生存期（mPFS）達14.7個月（研究者評估），盲態獨立評審委員會(BIRC)評估的mPFS更是長達17.5個月。更突破性地實現吡洛西利單藥後線治療應用，患者mPFS長達11個月，刷新全球同類療法紀錄，爲全球晚期乳腺癌後線治療提供更優方案。
吡洛西利此次獲批上市，不僅是集團創新研發實力的有力證明，也意味着公司在爲乳腺癌患者提供更有效治療方案的道路上邁出了堅實一步。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，爲全球患者的健康福祉貢獻更多力量。
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