華東醫藥(000963.SZ):華東醫藥(杭州)獨家商業化的IM19嵌合抗原受體T細胞注射液的註冊上市申請獲受理
格隆匯11月27日丨華東醫藥(000963.SZ)公佈,2024年11月27日,華東醫藥股份有限公司全資子公司華東醫藥(杭州)有限公司【以下簡稱“華東醫藥(杭州)”】獨家商業化的靶向CD19的自體CAR-T候選產品,IM19嵌合抗原受體T細胞注射液的藥品註冊上市許可申請獲國家藥品監督管理局受理。
IM19CAR-T細胞注射液是一種自體CD19(B細胞表面的一種白細胞分化抗原)靶向CAR-T細胞(嵌合抗原受體T細胞)產品,它是通過慢病毒轉導T細胞產生的。
IM19CAR-T細胞注射液註冊上市許可申請的受理,是基於一項在中國進行的開放標籤、單臂、多中心I/II期的臨牀試驗。研究結果顯示,IM19CAR-T細胞注射液針對復發或難治CD19陽性的非霍奇金淋巴瘤,具有良好的療效和安全性效。
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