復宏漢霖(02696.HK)：漢斯狀®(斯魯利單抗注射液)聯合化療同步放療用於侷限期小細胞肺癌(LS-SCLC)治療的3期臨牀試驗申請獲批
格隆匯3月31日丨復宏漢霖(02696.HK)宣佈，近日，公司自主開發的漢斯狀®(斯魯利單抗注射液)聯合化療同步放療用於侷限期小細胞肺癌(LS-SCLC)治療的3期臨牀試驗申請獲國家藥品監督管理局("NMPA")批准。
據悉，小細胞肺癌侵襲性強，預後極差，目前侷限期小細胞肺癌(LS-SCLC)標準治療方案為化療同步放療，治療效果有限。免疫治療聯合化療已被證實可延長廣泛期小細胞肺癌(ES-SCLC)患者的生存期，而放療已被證實可增加免疫檢查點治療的敏感性，提高免疫治療有效率，免疫治療聯合放化療標準治療有望成為侷限期小細胞肺癌(LS-SCLC)治療的新選擇。
漢斯狀®(斯魯利單抗注射液)為公司自主開發的創新型抗PD-1單抗，計劃用於多種實體瘤治療，除已獲批上市的經標準治療失敗的、不可切除或轉移性微衞星高度不穩定型(Microsatellite Instability-High, MSI-H)(「MSI-H」)實體瘤適應症外，公司亦同步就以漢斯狀®(斯魯利單抗注射液)為核心的9項聯合療法在全球多個國家和地區同步開展臨牀試驗。2021年9月，漢斯狀®(斯魯利單抗注射液)聯合化療一線治療局部晚期或轉移性鱗狀非小細胞肺癌(sqNSCLC)的上市註冊申請(NDA)獲NMPA受理。2021年12月，漢斯狀®(斯魯利單抗注射液)或安慰劑聯合化療(卡鉑－依託泊苷)在既往未接受過治療的廣泛期小細胞肺癌(ES-SCLC)患者中開展的一項隨機、雙盲、國際多中心3期臨牀研究第一次期中分析中，經獨立數據檢查委員會(IDMC)評估達到了總生存期(OS)的主要研究終點。2022年3月，NMPA附條件批准了漢斯狀®(斯魯利單抗注射液)用於治療不可切除或轉移性MSI-H的成人晚期實體瘤患者：既往經過氟尿嘧啶類、奧沙利鉑和伊立替康治療後出現疾病進展的晚期結直腸癌患者；既往至少二線治療後出現疾病進展且無滿意替代治療方案的晚期胃癌患者；既往至少一線治療後出現疾病進展且無滿意替代治療方案的其他晚期實體瘤患者。
基於漢斯狀®(斯魯利單抗注射液)良好的安全性數據及在其聯合化療(卡鉑－依託泊苷)一線治療廣泛期小細胞肺癌(ES-SCLC)3期臨牀研究中取得的顯着性的結果，公司擬在既往未接受過治療的侷限期小細胞肺癌(LS-SCLC)患者中開展國際多中心3期臨牀研究，以確證漢斯狀®(斯魯利單抗注射液)聯合化療同步放療的臨牀有效性和安全性。截至公吿日，於全球範圍內上市的靶向PD-1的單克隆抗體藥品包括默沙東製藥有限公司的可瑞達®、美國百時美施貴寶公司的歐狄沃®、再生元製藥(Regeneron Pharmaceuticals, Inc.)╱賽諾菲的Libtayo®等。於全球範圍內尚無PD-1產品獲批用於侷限期小細胞肺癌(LS-SCLC)治療。根據IQVIA MIDASTM提供的資料(IQVIA是全球領先的醫藥健康產業專業信息和戰略諮詢服務提供商)，2021年度，靶向PD-1的單克隆抗體藥品於全球範圍內的銷售金額約為280.8億美元。
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