Akeso, Inc. today announced that the National Center for Drug Evaluation of the State Drug Administration of the People's Republic of China (NMPA CDE) has granted priority review of the supplemental New Drug Application (sNDA) to (ivonescimab), a first-in-class PD-1/VEGF bi-specific antibody developed by Akeso, as  monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC).This marks the second indication for which ivonescimab has been granted priority review following the treatment of EGFR-mutant non-squamous NSCLC that has progressed after EGFR-TKI therapy, highlighting its significant clinical value.This new indication application for ivonescimab is based on the HARMONi-2 (AK112-303) study.At a prespecified interim analysis conducted by an independent Data Monitoring Committee,ivonescimab demonstrated a statistically significant and clinically meaningful improvement in PFS by blinded independent radiology review committee (BICR) compared to pembrolizumab, and the hazard ratio (HR) was significantly better than expected.

Akeso，Inc.今天宣布，中华人民共和国国家药品监督管理局国家药物评估中心（NMPA CDE）已优先审查补充新药申请（sNDA）至（ivonescimab），Akeso开发的一流PD-1/VEGF双特异性抗体，作为PD-L1阳性（PD-L1 TPS≥1%）局部晚期或转移性非小细胞肺癌（NSCLC）一线治疗的单一疗法。这标志着在EGFR-TKI治疗后进展的EGFR突变型非鳞状NSCLC治疗后，ivonescimab被授予优先审查的第二个适应症，突出了其重要的临床价值。ivonescimab的这种新适应症应用基于HARMONi-2（AK112-303）研究。在独立数据监测委员会进行的预先指定的中期分析中，与pembrolizumab相比，ivonescimab通过盲法独立放射学审查委员会（BICR）显示PFS有统计学意义和临床意义的改善，风险比（HR）明显优于预期。

There are no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting.In May 2024, ivonescimab combination therapy for EGFR-mutant non-squamous NSCLC that has progressed after EGFR-TKI therapy was approved through priority review, making it the world's first approved bispecific antibody that combines “tumor immunotherapy” and “anti-angiogenesis” mechanisms.About Ivonescimab (AK112/SMT112)Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso.

与pembrolizumab相比，在非小细胞肺癌中没有已知的III期临床试验显示出统计学上显着的改善。2024年5月，通过优先审查批准了EGFR-TKI治疗后进展的EGFR突变型非鳞状NSCLC的ivonescimab联合治疗，使其成为世界上第一个批准的结合“肿瘤免疫疗法”和“抗血管生成”机制的双特异性抗体。关于Ivonescimab（AK112/SMT112）Ivonescimab是由Akeso独立开发的新型全球一流PD-1/VEGF双特异性免疫治疗药物。

Ivonescimab is known as SMT112 in Summit Therapeutics' license territories, incl.

Ivonescimab在Summit Therapeutics的许可证领域被称为SMT112，包括。