復宏漢霖(02696.HK)擬向Alvogen Korea授出獨家許可，供其於韓國於領域內商業化漢斯狀®
格隆匯4月25日丨復宏漢霖(02696.HK)宣佈，公司於2025年4月25日與Alvogen Korea訂立一份許可協議，據此，公司向Alvogen Korea授出獨家許可，供其於韓國於領域內商業化漢斯狀®(斯魯利單抗注射液)(「許可產品」或「漢斯狀®」)。
漢斯狀®爲公司自主開發的創新型抗PD-1單抗，其於中國大陸境內(不包括中國港澳臺地區，下同)已獲批上市的適應症包括聯合化療一線治療鱗狀非小細胞肺癌(sqNSCLC)，廣泛期小細胞肺癌(ES-SCLC)、食管鱗狀細胞癌(ESCC)及非鱗狀非小細胞肺癌(nsNSCLC)。同時，漢斯狀®亦已分別於歐盟、印度尼西亞、柬埔寨、泰國獲批上市。漢斯狀®用於治療小細胞肺癌(SCLC)已分別於2022年4月、2022年12月獲美國食品藥品監督管理局(FDA)、歐盟委員會(EC)授予孤兒藥資格認定(Orphan-drug Designation)；漢斯狀®用於治療廣泛期小細胞肺癌(ES-SCLC)亦已獲韓國食品藥品安全部授予孤兒藥資格認定。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。
漢斯狀®在中國大陸境內的銷售推廣由本公司自建商業化團隊主導。截止目前，公司已分別與Intas Pharmaceuticals Ltd.、PT Kalbe Genexine Biologics、上海復星醫藥產業發展有限公司就漢斯狀®於約定的歐洲地區和印度、東南亞地區(10個國家)、中東及北非地區(12個國家)及美國等國家和地區的商業化達成合作。
漢斯狀®爲靶向PD-1的創新單抗產品，根據IQVIA MIDAS TM提供的資料(IQVIA是全球醫藥健康產業專業信息和戰略諮詢服務提供商)，2024年度，靶向PD-1的單抗藥品於全球範圍內的銷售金額約爲455.50億美元。
此次合作將有助於進一步拓展公司產品的海外市場，增強公司產品在國際市場的可及性和認可度，併爲公司收入的持續提升創造條件。
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