君實生物(01877.HK):特瑞普利單抗聯合貝伐珠單抗一線治療晚期肝細胞癌的新適應症上市申請獲得批准
格隆匯3月21日丨君實生物(01877.HK)公吿,近日,公司收到國家藥品監督管理局核准簽發的《藥品註冊證書》,特瑞普利單抗(商品名:拓益)聯合貝伐珠單抗用於不可切除或轉移性肝細胞癌患者的一線治療的新適應症上市申請獲得批准。這是特瑞普利單抗在中國獲批的第11項適應症。
本次新適應症的獲批主要基於HEPATORCH研究(NCT04723004)的數據結果。該研究是一項國際多中心、隨機、開放、陽性藥對照的III期臨牀研究,由中國科學院院士、復旦大學附屬中山醫院樊嘉教授擔任主要研究者,在中國大陸、中國台灣和新加坡的57家臨牀中心開展,共入組326例患者。該研究旨在評估與標準治療索拉非尼相比,特瑞普利單抗聯合貝伐珠單抗一線治療不可切除或轉移性肝細胞癌的有效性和安全性。
在國際化佈局方面,截至本公吿披露日,特瑞普利單抗已在美國、歐盟、印度、英國、約旦、澳大利亞等國家和地區獲得批准上市,並在全球多個國家或地區接受上市審評。
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