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復星醫藥(02196.HK):HLX22用於胃癌(GC)治療獲得歐盟孤兒藥資格認定
格隆匯 05-26 17:27

格隆匯5月26日丨復星醫藥(02196.HK)公佈,公司控股子公司 HenliusEurope GmbH 收到歐盟委員會(EC)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 為集團(即公司及控股子公司/單位,下同)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。2025 年 3 月,HLX22 用於治療胃癌(GC)已獲美國食品藥品監督管理局(FDA)授予孤兒藥資格認定(Orphan-drug Designation)。

截至本公吿日期(即 2025 年 5 月 26 日),HLX22 單藥用於治療 HER2 過表達晚期實體瘤於中國大陸境內已完成 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、日本及澳大利亞開展,且該國際多中心 III 期臨牀試驗申請已於美國等國家/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、HLX22 聯合標準治療或聯合德曲妥珠單抗治療 HER2 低表達 HR 陽性的局部晚期或轉移性乳腺癌於中國境內分別處於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 期臨牀試驗申請已獲中國國家藥品監督管理局批准。

截至 2025 年 4 月,集團現階段針對 HLX22(單藥)的累計研發投入約為人民幣 3.10 億元(未經審計;包含許可費)。

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