復星醫藥(02196.HK)控股子公司藥品獲美國FDA孤兒藥資格認定
格隆匯3月19日丨復星醫藥(02196.HK)發佈公告，公司控股子公司Henlius USA Inc.(繫上海復宏漢霖生物技術股份有限公司的控股子公司）收到美國FDA（即美國食品藥品監督管理局，下同）函件，HLX22（重組人源化抗HER2單克隆抗體注射液）用於胃癌（GC）治療獲得孤兒藥資格認定（Orphan-drug Designation）。
HLX22爲集團自AbClon, Inc.許可引進、並後續自主研發的新型靶向HER2的單克隆抗體，擬用於胃癌和乳腺癌等實體瘤的治療。
截至本公告日期（即2025年3月19日），HLX22單藥用於治療HER2過表達晚期實體瘤於中國境內（不包括港澳臺地區，下同）已完成I期臨牀研究；HLX22聯合標準治療（即曲妥珠單抗聯合化療，下同）一線治療局部晚期或轉移性胃食管交接部癌和胃癌的國際多中心III期臨牀試驗正在中國境內開展，且該國際多中心III期臨牀試驗申請已分別於美國、日本及澳大利亞等國家/地區獲許可；HLX22聯合標準治療一線治療HER2陽性的局部晚期/轉移性胃癌於中國境內處於II期臨牀試驗階段；此外，HLX22聯合斯魯利單抗注射液聯合標準治療一線治療局部晚期/轉移性胃癌的II期臨牀試驗申請、HLX22聯合標準治療或聯合德曲妥珠單抗治療HER2表達實體瘤的II期臨牀試驗申請均已獲國家藥品監督管理局批準。
截至2025年2月，集團現階段針對HLX22（單藥）的累計研發投入約爲人民幣3.04億元（未經審計）。根據IQVIA MIDAS最新數據，2024年，靶向HER2的單抗產品於全球範圍內的銷售額約爲90.29億美元。
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