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基石藥業-B(02616.HK)宣佈《British Journal of Clinical Pharmacology》發表擇捷美(舒格利單抗注射液)羣體藥代動力學研究成果
格隆匯 10-28 12:03

格隆匯10月28日丨基石藥業-B(02616.HK)宣佈,公司自研的PD-L1抗體擇捷美?(舒格利單抗注射液)羣體藥代動力學(PopPK)研究成果已在知名期刊《British Journal of ClinicalPharmacology》發表。

基石藥業首席執行官、研發總裁及執行董事楊建新博士表示:"該PopPK研究分析不僅通過模型揭示了舒格利單抗在不同患者羣體中的藥代動力學特徵,也為舒格利單抗標準劑量應用於不同患者羣體的合理性提供了詳實的科學證據。我們將繼續致力於推動舒格利單抗的全球開發和上市進程,力爭為更多患者提供創新的治療選擇。"

該研究通過PopPK建模,整合了九項I-III期臨牀試驗中1628名不同類型腫瘤患者的數據,涵蓋了非小細胞肺癌(NSCLC)、NK/T細胞淋巴瘤和食管鱗癌(ESCC)等多種適應症。研究結果顯示,舒格利單抗的PopPK模型能充分描述其在人體內的藥代動力學特徵。雖然體重、白蛋白、性別、抗藥抗體、腫瘤負荷和腫瘤類型對藥物清除率有一定影響,但這些因素影響的幅度較小(均小於20%),在臨牀上無顯著意義。

模型分析進一步支持了舒格利單抗已獲批的標準劑量(1200 mg、每三週一次給藥)在不同患者羣體中應用的合理性。結果表明,不同患者羣體,包括老年患者、不同種族的患者以及肝腎功能輕中度受損的患者,在該劑量下均能實現充分的藥物暴露,且無需針對特定協變量進行劑量調整,進一步表明了舒格利單抗用藥的便利性、以及對改善患者依從性的潛在助益。此外,模型的建立也為臨牀上一些極端情況下(如:體重>115kg)的用藥提供了指導。

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