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華昊中天醫藥-B(02563.HK):美國食品藥品管理局批准優替德隆膠囊一線治療晚期胃癌II/III期國際多中心臨牀研究
格隆匯 02-05 23:00

格隆匯2月5日丨華昊中天醫藥-B(02563.HK)公吿,集團的重要海外管線一,優替德隆膠囊("UTD2")聯合卡培他濱和奧沙利鉑一線治療PD-L1陰性的局部晚期或轉移性胃或胃食管交界處腺癌("該聯合療法")的國際多中心II/III期註冊臨牀研究("BG02-2404")已獲得美國食品藥品管理局("FDA")的批准。

集團利用特有的合成生物學技術平台開發的UTD2已順利完成美國I期臨牀研究,其安全性和療效得到充分驗證。截至本公吿日期,優替德隆在針對胃癌的臨牀研究中展現出優異的數據:在一項已完成的優替德隆聯合PD-1和奧沙利鉑一線治療不可切除的局部晚期或復發╱轉移HER2陰性胃癌的臨牀II期研究中,共計23例患者完成療效評估,其中15例實現部分緩解,8例實現疾病穩定,客觀緩解率達到65.2%,臨牀獲益率達到100%。UTD2也因此獲得了FDA授予的治療晚期胃癌孤兒藥資格認定。

相較於難以開發成口服劑型的紫杉類藥物,優替德隆不易被P-糖蛋白泵出胞外,具有口服給藥的優勢。UTD2將顯著提升患者用藥便利性和依從性,有助於長期的輔助和維持治療,減輕患者治療成本,展現巨大的應用潛力和市場空間。BG02-2404是本公司針對UTD2開展的首個國際多中心II/III期註冊臨牀研究,旨在進一步夯實公司國際化開發戰略的實施。

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