復宏漢霖(02696.HK)：漢斯狀®(斯魯利單抗注射液)用於治療小細胞肺癌(SCLC)獲歐盟委員會(EC)孤兒藥資格認定
格隆匯12月15日丨復宏漢霖(02696.HK)公吿，近日，公司控股子公司Henlius Europe GmbH收到歐盟委員會(EC)的函件，公司自主開發的漢斯狀®(斯魯利單抗注射液)("漢斯狀®")用於治療小細胞肺癌(SCLC)獲歐盟委員會(EC)授予孤兒藥資格認定。該資格認定乃由歐盟委員會(EC)根據歐洲藥品管理局(EMA)孤兒藥委員會(COMP)的積極意見授予。
漢斯狀®為公司自主開發的創新型抗PD-1單抗，於2022年3月在中國境內獲批上市。截至公吿日，漢斯狀®已於中國境內獲批兩項適應症：(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；及(2)聯合卡鉑和白蛋白紫杉醇用於一線治療不可手術切除的局部晚期或轉移性鱗狀非小細胞肺癌(sqNSCLC)患者。
此外，漢斯狀®另有2個適應症的上市註冊申請已獲國家藥品監督管理局("NMPA")受理：2022年4月，漢斯狀®聯合化療一線治療既往未經治療的廣泛期小細胞肺癌(ES-SCLC)的上市註冊申請(NDA)獲NMPA受理；2022年8月，漢斯狀®聯合化療一線治療局部晚期/復發或轉移性食管鱗狀細胞癌(ESCC)的上市註冊申請(NDA)獲NMPA受理。漢斯狀®用於治療小細胞肺癌(SCLC)已分別於2022年4月及2022年12月獲美國食品藥品監督管理局(FDA)及歐盟委員會(EC)授予孤兒藥資格認定(Orphan-drugDesignation)。2022年9月，漢斯狀®聯合化療一線治療廣泛期小細胞肺癌(ES-SCLC)的3期臨牀研究結果在全球四大頂級醫學期刊一的《美國醫學會雜誌》(JAMA，影響因子：157.3)在線發表。
漢斯狀計劃用於多種實體瘤治療，除已獲批上市的MSI-H實體瘤及鱗狀非小細胞肺癌(sqNSCLC)適應症外，本公司亦正就以漢斯狀為核心的11項聯合療法在全球多個國家和地區同步開展臨牀試驗。
本次獲歐盟委員會(EC)授予孤兒藥資格認定，有助於於漢斯狀®(斯魯利單抗注射液)用於治療小細胞肺癌(SCLC)在歐盟的後續研發、註冊及商業化等方面享受一定的政策支持，包括但不限於(1)臨牀研究方案協助；(2)可享受藥品集中審批程序；(3)在藥品獲批上市後享有10年市場獨佔權；及(4)監管活動費用的減免。歐盟孤兒藥資格認定的授予基於歐盟委員會No.141/2000法規，根據相關規定，若獲授予認定的產品在其獲得上市許可前已被確定不再符合孤兒藥資格認定標準的，應移除其孤兒藥註冊。
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