石藥集團(01093.HK):注射用西羅莫司(白蛋白結合型)於中國獲突破性治療認定
格隆匯2月28日丨石藥集團(01093.HK)公吿,集團開發的注射用西羅莫司(白蛋白結合型)("該產品")獲中華人民共和國國家藥品監督管理局授予突破性治療認定,擬定適應症為單藥用於惡性血管周圍上皮樣細胞瘤(PEComa)("該適應症")。
西羅莫司又稱為雷帕黴素,是一種常用的特異性mTOR抑制劑。此前已有口服制劑的西羅莫司獲批上市,主要適用於預防接受腎移植患者的器官排斥。該產品採用特殊技術將西羅莫司包裹於人血白蛋白中,克服口服制劑無法向靶部位遞送足夠濃度藥量的缺點,實現了西羅莫司的注射給藥,且無需激素預處理。同時,該產品拓展了西羅莫司的應用領域,有望實現治療mTOR信號通路驅動的一系列疾病。
該產品目前正在中國開展用於治療乳腺癌、軟組織肉瘤、肺癌、腎癌等實體瘤及血液瘤的多項II期及III期臨牀研究。乳腺癌位居女性惡性腫瘤的首位,全球女性乳腺癌新發病例約230萬例,經CDK4/6抑制劑治療失敗後的HR+/HER2-晚期乳腺癌患者存在極大未滿足的臨牀需求。該產品與內分泌治療聯合,是國內首款在CDK4/6抑制劑耐藥的HR+/HER2-晚期乳腺癌患者中開展臨牀試驗的mTOR抑制劑,集團已向監管部門遞交關鍵III期臨牀試驗溝通交流申請。
惡性PEComa國內尚無標準治療,存在未被滿足的臨牀需求。該產品已有臨牀數據證實其單藥療效顯著優於歷史數據,目前已進入關鍵III期入組階段。本次獲授予的突破性治療認定,將有助於進一步加快該產品的開發進度,使其有望成為國內首個針對該適應症的標準治療。
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