君實生物(01877.HK)：特瑞普利單抗一線治療黑色素瘤的新適應症上市申請獲得批準
格隆匯4月25日丨君實生物(01877.HK)公告，公司收到國家藥品監督管理局覈準簽發的《藥品註冊證書》，特瑞普利單抗（商品名：拓益）用於不可切除或轉移性黑色素瘤的一線治療的新適應症上市申請獲得批準。這是特瑞普利單抗在中國內地獲批的第12項適應症。
本次新適應症的獲批主要基於MELATORCH研究(NCT03430297)的數據結果。該研究是一項多中心、隨機、開放、陽性對照的III期臨牀研究，也是國內首個達成陽性結果的PD-(L)1抑制劑一線治療晚期黑色素瘤的關鍵註冊臨牀研究，由北京大學腫瘤醫院郭軍教授擔任主要研究者，在全國11家臨牀中心開展。該研究旨在比較特瑞普利單抗對比達卡巴嗪在既往未接受系統抗腫瘤治療的不可切除或轉移性黑色素瘤患者中的有效性和安全性。此前，MELATORCH的研究成果在第27屆全國臨牀腫瘤學大會暨2024年中國臨牀腫瘤學會(CSCO)學術年會上首次發佈。結果顯示，相較於達卡巴嗪組（N=128），特瑞普利單抗組（N=127）基於盲態獨立中心閱片(BICR)評估的無進展生存期（PFS）顯著延長，兩組中位PFS分別爲2.3個月和2.1個月，疾病進展或死亡風險降低29.2%（風險比HR=0.708,95%CI:0.526-0.954；P=0.0209）；矯正後續抗腫瘤治療影響的中位總生存期（OS）敏感性分析結果顯示，與達卡巴嗪組相比，特瑞普利單抗治療組顯示出明顯的生存獲益趨勢，中位OS分別爲15.1個月和9.4個月（HR=0.680,95%CI：0.486-0.951)；特瑞普利單抗的安全性良好，與既往研究一致，未發現新的安全信號。
在國際化佈局方面，截至本公告日期，特瑞普利單抗已在美國、歐盟、印度、英國、約旦、澳大利亞、新加坡等國家和地區獲得批準上市，並在全球多個國家和地區接受上市審評。
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