浙江醫藥(600216.SH):注射用重組人源化抗HER2單抗-AS269偶聯物(ARX788)獲批臨牀試驗
格隆匯 2 月 24日丨浙江醫藥(600216.SH)公佈,近日,公司及其下屬子公司浙江新碼生物醫藥有限公司收到國家藥品監督管理局核准簽發的注射用重組人源化抗HER2單抗-AS269偶聯物(ARX788)(原公吿簡稱“抗HER2-ADC”)《藥物臨牀試驗批准通知書》,同意開展用於胃癌和胃食管連接部腺癌治療的II/III期臨牀試驗。
重組人源化抗HER2單抗-AS269偶聯注射液是公司於2013年6月14日與美國Ambrx公司簽署《合作開發和許可協議》合作研發的新一代單克隆抗體偶聯藥物,用於治療HER2陽性晚期乳腺癌和胃癌等,屬於創新生物技術藥物。
公司於2019年啟動ARX788治療HER2陽性晚期轉移性胃癌及胃食管連接部腺癌患者的I期臨牀研究,該臨牀研究在中山大學腫瘤防治中心等5家臨牀中心同時開展,目前已完成所有受試者入組。
公司於2017年啟動ARX788單藥治療HER2陽性晚期乳腺癌的I期臨牀研究,該臨牀研究已完成所有受試者入組;2020年進入ARX788治療HER2陽性局部晚期或轉移性乳腺癌的II/III期臨牀研究,該臨牀研究正在復旦大學附屬腫瘤醫院等49家中心同時開展(臨牀許可獲得詳見公司於2019年12月20日在上海證券交易所網站www.sse.com.cn披露的臨2019-042號公吿)。
截至2020年12月31日,公司ARX788項目已累計投入研發費用3.45億元人民幣,其中胃癌I期臨牀研究投入700.43萬元人民幣。
目前國外已上市的靶向HER2治療用藥包括曲妥珠單抗(羅氏公司原研,商品名Herceptin,2020年銷售額為37.32億瑞士法郎)和fam-trastuzumab deruxtecan(阿斯利康/第一三共公司原研,商品名Enhertu,暫無銷售數據),其中曲妥珠單抗聯合化療為HER2陽性晚期胃或胃食管交界性(GEJ)腺癌一線治療,國內已上市;fam-trastuzumab deruxtecan於2021年01月15日獲得FDA批准用於曲妥珠單抗治療進展的HER2陽性轉移性GEJ腺癌患者,目前國內未進行相關研究,藥物未上市。榮昌生物製藥(煙台)有限公司的RC48-ADC正在申報上市用於HER2陽性晚期GEJ三線治療。
根據國際癌症研究機構的數據,2018年有超過一百萬新診斷的胃癌病例,胃癌已成為全球第五大最常見的惡性腫瘤。根據美國癌症協會的估計,2020年將有27,600例胃癌患者確診。根據EVALUATEPHARMA的數據,2018年HER2靶點抗腫瘤市場全球銷售額達110.7億美元,並預計2024年可增長至156億美元。
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