和鉑醫藥-B(02142.HK):NMPA批准HBM4003治療NSCLC與實體瘤聯合臨試IND申請
格隆匯 2 月 26日丨和鉑醫藥-B(02142.HK)發佈公吿,國家藥品監督管理局(“NMPA”)已批准集團在研產品HBM4003抗CTLA-4全人源單克隆重鏈抗體、與程序性細胞死亡蛋白1(PD-1)抗體╱化療治療晚期鱗狀非小細胞肺癌(“NSCLC”)及其他實體瘤患者聯合治療的臨牀試驗IND許可。
集團就以HBM4003作為晚期實體瘤的單一療法進行一期試驗,已獲得美國食品藥品管理局IND批准,並在中國獲得NMPA的IND批准。另外,集團亦獲得 NMPA就HBM4003進行聯合療法的另一項IND批准。集團亦正在澳洲進行I期臨牀試驗。
據悉,HBM4003是抗CTLA-4全人源單克隆重鏈抗體,產生自和鉑醫藥特有的Harbour Mice®平台。HBM4003 顯示出增強的抗體依賴性細胞介導的細胞毒性作用(ADCC),對腫瘤組織中的CTLA-4(high) Treg細胞具有極高的特異性。其強效的抗腫瘤作用、差異化的藥代動力學特徵和持久的藥效展現出良好的產品特性,這種新穎和差異化的作用機制使其具有提高治療效果並顯著降低藥物毒性的潛力。
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