China's NMPA Grants Priority Review to Ivonescimab for First-Line PD-L1 Positive NSCLC Treatment

Akeso, Inc. (HKEX: 9926.HK) has announced that the National Center for Drug Evaluation of the State Drug Administration of China has prioritized the review of a supplemental New Drug Application (sNDA) for ivonescimab, a groundbreaking PD-1/VEGF bispecific antibody developed by Akeso. This sNDA seeks approval for using ivonescimab as a first-line treatment for PD-L1 positive advanced or metastatic non-small cell lung cancer (NSCLC). The drug's potential for treating lung cancer has been underscored by its recent priority review status for another indication, emphasizing its clinical importance.

Previously, ivonescimab was approved in May 2024 for treating EGFR-mutant, non-squamous NSCLC that had progressed following EGFR-TKI therapy. This approval marked a significant milestone as ivonescimab became the world's first bispecific antibody leveraging both tumor immunotherapy and anti-angiogenesis mechanisms. The current priority review for its new indication is based on findings from the HARMONi-2 (AK112-303) study. An interim analysis by an independent Data Monitoring Committee revealed that ivonescimab considerably improved progression-free survival (PFS) compared to pembrolizumab, with the hazard ratio exceeding expectations. Notably, no other Phase III trials in NSCLC have demonstrated a statistically significant improvement over pembrolizumab in a direct comparison.

Ivonescimab, also known as SMT112 in regions licensed to Summit Therapeutics—including the U.S., Canada, Europe, Japan, and several other territories—has showcased its innovative potential. The drug has already received marketing approval in China for treating locally advanced or metastatic non-squamous NSCLC in patients with EGFR mutations who have progressed after EGFR TKI treatment. Akeso is currently conducting five Phase III trials for ivonescimab, including two global multi-regional clinical trials (MRCTs) and four registrational trials against anti-PD-1 therapies. Additionally, ivonescimab is being tested in multiple clinical trials for 16 different indications, including gastrointestinal cancer, hepatocellular carcinoma, and colorectal cancer.

Founded in 2012, Akeso is a prominent biopharmaceutical company dedicated to developing innovative biological medicines. The company has established a comprehensive R&D platform and a unique bi-specific antibody development technology known as Tetrabody. Akeso's integrated system includes a GMP-compliant manufacturing process and a sophisticated commercialization strategy, positioning it as a competitive player in the global biopharmaceutical industry.

Akeso's extensive pipeline includes over 50 innovative assets targeting a range of diseases, with 19 drug candidates currently in clinical stages, including eight multispecific antibodies. The company has successfully commercialized three biological drugs and submitted marketing applications for multiple indications of four new drugs. Among its notable achievements, Penpulimab® (an Fc-modified PD-1 monoclonal antibody) was approved in August 2021, and Cadonilimab® (a PD-1/CTLA-4 bispecific antibody) received approval in June 2022, marking significant advancements in tumor immunotherapy.

In May 2024, ivonescimab gained approval as the first-in-class PD-1/VEGF bispecific antibody for treating EGFR-mutant locally advanced or metastatic non-squamous NSCLC, further solidifying Akeso's position as a leader in innovative cancer treatments. The company's commitment to developing first-in-class and best-in-class new drugs aims to provide cost-effective therapeutic antibodies globally, continuously creating commercial and social value in its quest to become a leading biopharmaceutical enterprise.

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