双特异性抗体(bsAb)是与单特异性单克隆抗体(mAb)相比可介导新的作用机制的一类抗体。自从发现单克隆抗体并在1980年代和1990年代将其用作治疗剂以来,bsAbs的发展具有很大的吸引力。然而,只有三个bsAb(Catumaxomab,blinatumomab,emicizumab)在2020年底获得批准。然而,从那以后,11个bsAbs获得了监管机构的批准,其中九个(amivantamab,Tebentafusp,莫苏尼图珠单抗,Cadonilimab,替科利他单抗,Glofitamab,epcoritamab,talquetamab,elranatamab)被批准用于治疗癌症和两个(faricimab,ozoralizumab)在非肿瘤学适应症中。值得注意的是,在目前批准的13个bsAbs中,两个,emicizumab和faricimab,取得了轰动一时的地位,展示了这种新型疗法的前景。在2020年代,可以预期在血液恶性肿瘤中批准额外的bsAb,实体肿瘤和非肿瘤学适应症,建立bsAb作为治疗性医疗设备的重要组成部分。
Bispecific antibodies (bsAbs) are a class of antibodies that can mediate novel mechanisms of action compared to monospecific monoclonal antibodies (mAbs). Since the discovery of mAbs and their adoption as therapeutic agents in the 1980s and 1990s, the development of bsAbs has held substantial appeal. Nevertheless, only three bsAbs (catumaxomab, blinatumomab, emicizumab) were approved through the end of 2020. However, since then, 11 bsAbs received regulatory agency approvals, of which nine (amivantamab, tebentafusp, mosunetuzumab, cadonilimab, teclistamab, glofitamab, epcoritamab, talquetamab, elranatamab) were approved for the treatment of cancer and two (faricimab, ozoralizumab) in non-oncology indications. Notably, of the 13 currently approved bsAbs, two, emicizumab and faricimab, have achieved blockbuster status, showing the promise of this novel class of therapeutics. In the 2020s, the approval of additional bsAbs can be expected in hematological malignancies, solid tumors and non-oncology indications, establishing bsAbs as essential part of the therapeutic armamentarium.