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於日本獲許可開展一線治療轉移性結直腸癌的國際多中心3期臨牀試驗
格隆匯7月2日丨復宏漢霖(02696.HK)宣佈，近日，向日本藥品醫療器械綜合機構(PMDA)提交的漢斯狀®(斯魯利單抗注射液)("漢斯狀®")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期臨牀試驗通知獲得默示許可，根據有關規定，相關臨牀試驗可以在日本開展。
漢斯狀®為公司自主開發的創新型抗PD-1單抗，於2022年3月在中國境內(不包括港澳台地區，下同)獲批上市。截至公吿日，漢斯狀®已於中國境內獲批四項適應症：(1)用於治療經標準治療失敗的、不可切除或轉移性微衞星高度不穩定(MSI-H)成人晚期實體瘤患者；(2)聯合卡鉑和白蛋白紫杉醇適用於不可手術切除的局部晚期或轉移性鱗狀非小細胞肺癌(NSCLC)的一線治療；(3)聯合卡鉑和依託泊苷適用於廣泛期小細胞肺癌(ES-SCLC)的一線治療；及(4)聯合含氟尿嘧啶類和鉑類藥物用於PD-L1陽性的不可切除局部晚期/復發或轉移性食管鱗狀細胞癌(ESCC)的一線治療。此外，漢斯狀®第五項適應症一線治療非鱗狀非小細胞肺癌(nsNSCLC)的上市註冊申請(NDA)亦獲國家藥品監督管理局(NMPA)受理。於國際市場，漢斯狀®用於治療廣泛期小細胞肺癌(ES-SCLC)已獲印度尼西亞食品藥品監督管理局(BPOM)批准，成為首個在東南亞國家獲批上市的國產PD-1單抗，其於歐盟的上市許可申請(MAA)亦獲得歐洲藥品管理局(EMA)受理，於美國的橋接試驗正穩步推進中。公司亦正有序推進漢斯狀®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。
截至公吿日，漢斯狀®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)正於中國境內處於2/3期臨牀試驗中。2期臨牀研究已有數據顯示，該聯合用藥方案可改善患者的無進展生存期及其他療效指標，且安全性可控。在此基礎上，公司計劃開展該聯合用藥方案的國際多中心3期臨牀研究。除已於日本獲批外，該國際多中心3期臨牀研究亦已於中國境內完成首例患者給藥。
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