和鉑醫藥(02142.HK)新一代HBM4003獲藥監局批準兩項臨牀試驗許可
和鉑醫藥(02142.HK)公佈,國家藥監局已批準集團新一代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抗體對晚期肝細胞癌及其他實體瘤患者聯合治療的臨牀試驗IND許可,以及HBM4003與PD-1抗體對晚期神經內分泌腫瘤或癌及其他實體瘤患者聯合治療的臨牀試驗IND許可。
集團指,已分別獲得美國食品藥品管理局及中國NMPA的IND批準,開展HBM4003單藥治療晚期實體瘤的一期試驗。同時亦正在澳洲及中國就HBM4003單藥療法進行I期臨牀試驗,及於中國就HBM4003聯合療法進行I期臨牀試驗。
HBM4003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,其在單藥及聯合用藥療法中具有提高治療效果並顯着降低藥物毒性的潛力。
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