香雪製藥(300147.SZ):TAEST1901注射液獲批臨牀試驗
格隆匯4月20日丨香雪製藥(300147.SZ)公佈,公司孫公司香雪生命科學技術(廣東)有限公司(簡稱“香雪生命科學”)收到了國家藥監局簽發的《藥物臨牀試驗批准通知書》(編號:2022LP00657),香雪生命科學於2022年1月向國家藥監局提交的TAEST1901注射液新藥臨牀註冊申請已獲得臨牀試驗許可。適應症:用於治療組織基因型為HLA-A*02:01,腫瘤抗原AFP表達為陽性的晚期肝癌或其它晚期腫瘤。
TAEST1901注射液是HLA-A*02:01/AFP特異性的親和力增強的TCR-T治療產品,針對的靶點是HLA-A*02:01及AFP抗原肽組成的複合物,使用慢病毒轉導自體T細胞,表達AFP抗原特異性的TCR。通過系統的臨牀前研究,TAEST1901注射液在安全特性上顯示了良好的安全性;在有效性上,TAEST1901在體內/外針對HLA-A*02:01和AFP雙陽性的靶細胞具有良好的特異性藥效。目前,香雪生命科學在中國完成了針對基因型為HLA-A*02:01,腫瘤抗原AFP表達為陽性的肝細胞癌的TCR-T新藥TAES1901的臨牀前研究工作。
香雪生命科學已建立TCR-T完整的技術平台及工藝,具有完整的自主知識產權,TAEST1901注射液是其自2019年3月獲得國內首個TCR-T產品(TAEST16001注射液)IND批件後的第二個獲得臨牀試驗許可的TCR-T產品,後續也會隨着研發進度開發更多的產品。
TAEST1901注射液屬於治療用生物製品1類創新藥,如產品能夠獲批上市,將豐富公司在抗腫瘤藥物領域的產品線,確立公司在TCR-T免疫細胞治療的領先地位,有利於增強公司的核心競爭力。
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