浙江醫藥(600216.SH):抗HER2-ADC獲批開展臨牀試驗
格隆匯4月22日丨浙江醫藥(600216.SH)公佈,近日,公司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HER2表達或突變晚期實體瘤治療的臨牀試驗。
注射用重組人源化抗HER2單抗-AS269偶聯物(ARX788)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,該臨牀研究已達到研究終點,仍有部分受試者持續接受後續治療;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86家中心同時開展。
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,目前該試驗已完成。2021年進入ARX788治療HER2陽性晚期轉移性胃癌及胃食管連接部腺癌的II/III期臨牀研究,該臨牀研究正在中山大學腫瘤防治中心等80家中心同時開展。
截至2022年3月31日,公司ARX788項目已累計投入研發費用5.55億元人民幣。
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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