復宏漢霖(02696.HK)：漢斯狀®(斯魯利單抗注射液)聯合貝伐珠單抗注射液聯合化療一線治療轉移性結直腸癌(mCRC)的國際多中心3期臨牀研究完成日本首例患者給藥
格隆匯10月24日丨復宏漢霖(02696.HK)宣佈，近日，一項漢斯狀®(斯魯利單抗注射液)("漢斯狀®")聯合貝伐珠單抗聯合化療一線治療轉移性結直腸癌(mCRC)的2/3期臨牀試驗的第三階段(國際多中心3期臨牀研究)已完成日本首例患者給藥。該3期臨牀研究亦正於中國境內與印度尼西亞開展中。
本研究是一項漢斯狀®聯合貝伐珠單抗及化療(XELOX)，對比安慰劑聯合貝伐珠單抗及化療(XELOX)，一線治療轉移性結直腸癌(mCRC)的多中心、隨機、雙盲、平行對照、分三階段開展的2/3期臨牀試驗。第一階段為單臂的安全導入期，主要目的為評價漢斯狀®聯合貝伐珠單抗及化療一線治療轉移性結直腸癌(mCRC)患者的安全性和耐受性。第二階段為多中心、隨機、雙盲、平行對照的2期臨牀研究，其主要目的為通過評估主要終點無進展生存期(PFS)比較兩個給藥組的臨牀療效，次要目的包括評估其他療效終點、藥物代謝動力學特徵、安全性和耐受性。第三階段為在2期研究主要療效結果的基礎上開展的國際多中心3期臨牀研究，試驗設計參照2期，並與2期研究主要目的及次要目的一致。
據悉，漢斯狀®為公司自主開發的創新型抗PD-1單抗。漢斯狀®於2022年3月在中國境內(不包括港澳台地區，下同)獲批上市，相關適應症包括聯合化療一線治療鱗狀非小細胞肺癌(NSCLC)，廣泛期小細胞肺癌(ES-SCLC)及食管鱗狀細胞癌(ESCC)等。2023年12月，漢斯狀®聯合化療一線治療非鱗狀非小細胞肺癌(NSCLC)的上市註冊申請(NDA)獲國家藥品監督管理局受理。同時，漢斯狀®亦已分別於印度尼西亞、柬埔寨、泰國獲批上市，用於治療廣泛期小細胞肺癌(ES-SCLC)。2023年3月，漢斯狀®一線治療廣泛期小細胞肺癌(ES-SCLC)的營銷授權申請(MAA)於歐盟獲歐洲藥品管理局("EMA」"受理；並於2024年9月獲EMA人用醫藥產品委員會(CHMP)積極審評意見。
此外，公司正有序推進漢斯狀®及相關聯合療法在全球開展的多項臨牀試驗，廣泛覆蓋肺癌、食管癌、頭頸鱗癌、結直腸癌和胃癌等適應症。
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