榮昌生物(09995.HK):國家藥品監督管理局批準注射用維迪西妥單抗用於治療HER2陽性且存在肝轉移的晚期乳腺癌在中國上市
格隆匯5月9日丨榮昌生物(09995.HK)公告,注射用維迪西妥單抗(商品名:愛地希)正式獲得中國國家藥品監督管理局(NMPA)在中國上市的批準,用於治療HER2陽性且存在肝轉移的晚期乳腺癌的患者。
本適應症獲得批準是基於RC48-C006 III期臨牀研究,詳細數據在2024年12月的聖安東尼奧乳腺癌研討會(SABCS)公佈,結果顯示:相比拉帕替尼聯合卡培他濱組,維迪西妥單抗組顯著延長了無進展生存期(PFS),疾病進展或死亡風險降低了44%(中位PFS:9.9個月vs 4.9個月;風險比(HR)=0.56,P=0.0143)。總生存期(OS)數據尚未成熟,但維迪西妥單抗組已顯示出更強的獲益趨勢,中位OS分別爲不可評估(Not Evaluable) vs 25.9個月(HR=0.56, 95% CI:0.25-1.29)。維迪西妥單抗組整體安全性良好,未發現新的安全性信號。
維迪西妥單抗是公司研發的中國首個原創抗體偶聯(ADC)藥物,以腫瘤表面的HER2蛋白爲靶點,能精準識別和殺傷腫瘤細胞,在治療胃癌、尿路上皮癌、乳腺癌等腫瘤的臨牀試驗中均取得了全球領先的臨牀數據,是中國首個獲得美國FDA、中國NMPA突破性療法雙重認定的ADC藥物,其用於治療胃癌、尿路上皮癌的新藥上市申請經優先審評審批程序,並作爲具有突出臨牀價值的臨牀急需藥品分別於2021年6月、2021年12月在中國獲附條件批準上市。
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