Portfolio News

HONG KONG, July 28, 2025 - Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is pleased to announce that the National Medical Products Administration (NMPA) has accepted the supplementary New Drug Application (sNDA) for ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC). 

This submission represents the third accepted application for ivonescimab in China, following previous filings for its combination therapy in EGFR-TKI resistant locally advanced or metastatic non-squamous NSCLC (nsq-NSCLC), as well as its monotherapy for first-line treatment of PD-L1 positive advanced NSCLC.  

PD-1 combined with chemotherapy has become a cornerstone in cancer therapy. The sNDA for ivonescimab’s new indication is based on the strong positive outcomes from its Phase III trial (AK112-306/HARMONi-6 study), which showed that ivonescimab combined with chemotherapy is superior to tislelizumab plus chemotherapy. Building on the success of its head-to-head comparison with pembrolizumab, ivonescimab’s ability to outperform PD-1 combination therapy marks a significant step forward in the evolution of global cancer immunotherapy. 

Currently, ivonescimab is involved in over 12 registrational/Phase III clinical trials worldwide, including six head-to-head studies with PD-1/L1 inhibitors. These trials span a diverse range of malignancies, such as various subtypes of lung cancer, first-line colorectal cancer, first-line head and neck squamous cell carcinoma, first-line biliary tract cancer, first-line pancreatic cancer, and first-line triple-negative breast cancer, among others. Ivonescimab has established a broad and strategic footprint across key cancer immunotherapy indications. As part of the company’s “IO+ADC” 2.0 oncology strategy, ivonescimab is positioned as a cornerstone agent in immuno-oncology, being evaluated in combination with innovative therapies targeting novel mechanisms and pathways.