復宏漢霖-B(02696.HK):斯魯利單抗注射液上市註冊申請獲國家藥監局受理並擬納入優先審評
格隆匯4月22日丨復宏漢霖-B(02696.HK)公吿,近日,公司自主開發的斯魯利單抗注射液(重組抗PD-1人源化單克隆抗體注射液,原項目代號:HLX10)用於經標準治療失敗的、不可切除或轉移性高度微衞星不穩定型(Microsatellite Instability-High,MSI-H)實體瘤治療的上市註冊申請(NDA)獲國家藥品監督管理局(NMPA)藥品審評中心受理,並進入擬納入優先審評審批程序公示期。
此次斯魯利單抗注射液就經標準治療失敗的、不可切除或轉移性高度微衞星不穩定型實體瘤向NMPA遞交的上市註冊申請(NDA)主要基於目前已獲得的有效性和安全性數據。2021年3月,斯魯利單抗注射液用於經標準治療失敗的、不可切除或轉移性高度微衞星不穩定型實體瘤的關鍵性2期臨牀研究達到主要研究終點,該臨牀研究結果表明了斯魯利單抗注射液在該適應症上良好的療效及安全性。此外,斯魯利單抗注射液多項正在進行的其他臨牀研究也支持了其在腫瘤患者中的安全性。
斯魯利單抗注射液為公司自主開發的創新型抗PD-1單抗,計劃用於實體瘤及慢性B型肝炎(即慢性乙型肝炎)治療,目前正在全球開展多項單藥及聯合療法的臨牀研究。
截至本公吿日,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、蘇州盛迪亞生物醫藥有限公司(江蘇恆瑞醫藥股份有限公司的全資子公司)的艾瑞卡等。截至目前,國內尚無同類產品就該適應症(經標準治療失敗的、不可切除或轉移性高度微衞星不穩定型實體瘤)獲批上市。根據IQVIAMIDASTM提供的資料,2020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230.75億美元。
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