concizumab

Concizumab (mAb 2021) is a high-affinity, humanized, monoclonal IgG4 antibody (mAb) developed by Novo Nordisk A/S. It was directed against the Kunitz-2 domain of human tissue factor (TF) pathway inhibitor (TFPI), designed to target and selectively block the factor X (FX) a (FXa) binding site of TFPI. As a mAb, concizumab has the advantage of being administered subcutaneously, and exhibits good solubility and stability, allowing administration as a liquid formulation via a ready- and easy-to-use portable pen device. Phase 2 trials of concizumab are ongoing for Haemophilia A and B. On 12 October 2017, orphan designation (EU/3/17/1940) was granted by the European Commission to Novo Nordisk A/S, Denmark, for concizumab for the treatment of haemophilia B.康昔单抗（Concizumab，mAb 2021）是由丹麦诺和诺德公司（Novo Nordisk A/S）开发的高亲和力人源化单克隆IgG4抗体（monoclonal antibody, mAb）。该抗体靶向人类组织因子（tissue factor, TF）途径抑制剂（TF pathway inhibitor, TFPI）的Kunitz-2结构域，旨在精准靶向并选择性阻断TFPI的X因子（factor X, FX）a（FXa）结合位点。作为单克隆抗体，康昔单抗具备皮下给药的独特优势，且溶解性与稳定性优异，可通过即用型、操作便捷的便携式笔式装置以液体制剂形式完成给药。目前，康昔单抗针对A型血友病与B型血友病的II期临床试验正在有序推进中。2017年10月12日，欧盟委员会向丹麦诺和诺德公司授予了康昔单抗用于治疗B型血友病的孤儿药资格认定（EU/3/17/1940）。