Ivonescimab (®) 是康方生物制药开发的一款针对程序性细胞死亡蛋白 1 (PD-1) 和血管内皮生长因子 (VEGF)-A 的一流人源化四价双特异性单克隆抗体，用于治疗非小细胞肺癌（NSCLC）和其他实体瘤，包括乳腺癌、肝癌和胃癌。 Ivonescimab 同时阻断 PD-1 与其配体 (PD-L1) 的结合，从而缓解 PD-1/PD-L1 介导的免疫抑制，并阻断 VEGF-A 与其受体 (VEGFR2) 的结合，从而阻断肿瘤血管生成在肿瘤微环境中。 2024年5月，ivonescimab联合培美曲塞和卡铂在中国首次获得批准，用于治疗经酪氨酸激酶抑制剂（TKI）治疗后病情进展的EGFR突变局部晚期或转移性非鳞状NSCLC患者。全球多个国家正在进行 ivonescimab 的临床研究。本文总结了 ivonescimab 开发过程中的里程碑，这些里程碑导致首次批准用于治疗 TKI 治疗后病情进展的 EGFR 突变局部晚期或转移性非鳞状 NSCLC。© 2024。作者获得 Springer Nature Switzerland 的独家许可股份公司。

Ivonescimab (®) is a first-in-class, humanized, tetravalent bispecific monoclonal antibody targeting programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF)-A being developed by Akeso Biopharma for the treatment of non-small cell lung cancer (NSCLC) and other solid tumours, including breast cancer, liver cancer and gastric cancer. Ivonescimab simultaneously blocks the binding of PD-1 to its ligand (PD-L1), thereby relieving PD-1/PD-L1-mediated immunosuppression, and blocks the binding of VEGF-A to its receptor (VEGFR2), thus blocking tumour angiogenesis in the tumour microenvironment. In May 2024, ivonescimab, in combination with pemetrexed and carboplatin, received its first approval in China for the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after tyrosine kinase inhibitor (TKI) therapy. Clinical studies of ivonescimab are underway in multiple countries worldwide. This article summarizes the milestones in the development of ivonescimab leading to this first approval for EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after TKI therapy.© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.