榮昌生物-B(09995.HK):抗體偶聯藥物RC118已在澳洲獲得I期臨牀試驗倫理許可
格隆匯7月30日丨榮昌生物-B(09995.HK)公吿,公司收到了澳洲人類研究倫理委員會就抗體偶聯藥物(ADC)RC118 I期臨牀試驗簽發的倫理許可。公司將在澳洲開展針對Claudin18.2表達陽性患者的局部晚期不可切除或轉移性惡性實體瘤的I期臨牀試驗。RC118是公司第四款進入臨牀開發階段的ADC藥物。
近來全球ADC藥物市場碩果累累,許多ADC產品對多種實體瘤適應症顯示出巨大潛力。公司在該領域不斷完善、優化自身的ADC產品線。這是繼RC48(維迪西妥單抗)、RC88、RC108之後公司開發的另一個重要的ADC產品。
RC118是公司第四款進入臨牀研究的抗體偶聯藥物(ADC)。它由重組的人源化抗Claudin18.2單克隆抗體和小分子微管抑制劑單甲基澳瑞他汀E(MonomethylAuristatin E, MMAE)(一種半最大抑制濃度(IC50)在亞納摩爾等級範圍內的有效微管蛋白結合劑,作為毒素載荷),通過可被組織蛋白酶可剪切的連接子(Linker)彼此偶聯而成,並具有優化的藥物-抗體比率。I期臨牀研究將圍繞Claudin18.2表達陽性患者的各類實體瘤展開。
公司亦於2021年7月向中國國家藥品監督管理局(NMPA)提交了該產品的IND申請,目前正在等待正式批准,然後公司將在中國啟動I期臨牀試驗。
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