双特异抗体的应用包括癌症治疗、靶向递送(双特异抗体可以用于将药物或其他治疗剂更精准地递送到特定的病变部位,从而减少对健康组织的副作用)、阻断多重信号通路(在一些疾病中,多种信号通路可能同时参与疾病进展,双特异抗体可以同时阻断这些信号通路,从而提高治疗效果)等等。目前,已经有15款双抗获批用于临床治疗,除3款(Emicizumab、Faricimab、Ozoralizumab)用于非肿瘤适应症,其他都是针对肿瘤适应症(Klein et al., 2024. Nat Rev Drug Discov 23:301–319)。更多的双特异抗体正在进行临床试验。
Trade Name
Active Ingredient
Targets
Year Approved
Indication
Removab
Catumaxomab
EpCAMxCD3
2009 (EU)
Malignant ascites (MA) in adults
Blincyto
Blinatumomab
CD19xCD3
2014
Relapsed or refractory B cell precursor ALL
Hemlibra
Emicizumab
FIXa / FX
2017
To prevent or reduce the frequency of bleeding episodes in hemophilia A with factor VIII inhibitors
Rybrevant
Amivantamab
EGFRxMET
2021
NSCLC with certain mutations
Kaitanni
Cadonilimab
PD1xCTLA4
2022 (China)
Relapsed or metastatic cervical cancer
Kimmtrak*
Tebentafusp
(MHC:gp100p)xCD3
2022
To treat a form of unresectable or metastatic uveal melanoma
Vabysmo
Faricimab
Ang-2xVEGF-A
2022
Neovascular (wet) age-related macular degenerated and diabetic macular edema
Tecvayli
Teclistamab
BCMAxCD3
2022
Relapsed or refractory multiple myeloma (RRMM)
Lunsumio
Mosunetuzumab
CD20xCD3
2022
RRMM
Epkinly
Epcoritamab
CD20xCD3
2023
To treat relapsed or refractory diffuse large B-cell lymphoma
Columvi
Glofitamab
CD20xCD3
2023
To treat relapsed or refractory diffuse large B-cell lymphoma or large B-cell lymphoma