产品：诺易^®

介绍：

诺易^®是第三代B结构域删减重组人凝血因子Ⅷ（Turoctocog alfa），用于成人和儿童血友病A(先天性凝血因子Ⅷ缺乏)患者按需和预防治疗出血。诺易^®（Turoctocog alfa）通过基因重组技术，利用中国仓鼠卵巢（CHO）细胞生产，生成过程中未添加人或动物来源蛋白，采用五步纯化工艺，降低病原体传播风险。多项Guardian临床研究证实，诺易^®（Turoctocog alfa）在重型血友病A既往经治疗患者（PTP）中可安全预防和治疗出血，PTP抑制物发生率为0。诺易^®（Turoctocog alfa）在中国全年龄组重型血友病A既往经治疗患者中可安全有效预防和治疗出血：止血治疗成功率为95.4%，接受预防治疗患者的中位年化出血率为1.18次出血/患者/年，在有治疗疗效记录的8例手术中，术中及术后均能有效控制出血。诺易^®：血友病A患者安心之选。

Product: NovoEight^®

Introduction:

NovoEight^® (Turoctocog alfa) is a third-generation, B domain-truncated, Recombinant Human Coagulation Factor Ⅷ for the treatment and prophylaxis of bleeding in patients of all ages with haemophilia A (congenital factor Ⅷ deficiency). NovoEight^® (Turoctocog alfa) is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells, and prepared without the addition of any human or animal derived protein in the cell culture process, purification or final formulation. The five-step purification process robust virus clearance.

NovoEight^® (Turoctocog alfa) demonstrated favorable safety in previously treated patients (PTP) with severe hemophilia A in many guardian clinical trials, no FⅧ inhibitors (≥0.6BU)were reported in guardian clinical trials. 

NovoEight^® (Turoctocog alfa) was safe and effective for prophylaxis and treatment of bleeding episodes in PTP patients from China with severe hemophilia A across all ages: hemostatic success was 95.4%, the overall median ABR was 1.18 bleeds/ patient/year for prophylaxis patients, hemostatic response to turoctocog alfa was successful during and after all eight surgeries for which responses were recorded. NovoEight^®, your reliable choice.

参考文献 Reference

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