Akeso Inc. (9926.HK), a leading biopharmaceutical company, has announced major advancements in its antibody drug pipeline, underscoring a transformative year in oncology and immunotherapy.

ivonescimab, the world’s first immuno + anti-vascular bispecific antibody, has been approved for EGFR-TKI resistant non-squamous NSCLC, with topline results from the pivotal Phase III HARMONi study expected mid-2025. The drug also received FDA Fast Track Designation (FTD), positioning it as a next-generation immunotherapy option.

Further validating its potential, ivonescimab outperformed pembrolizumab in a Phase III study for first-line PD-L1+ NSCLC, with a hazard ratio (HR) for mPFS of 0.51, and is now under priority review in China.

Akeso also celebrated the approval of cadonilimab for first-line gastric cancer, marking a critical advancement for PD-L1 low/negative patients, and the sNDA for cervical cancer is currently under review. Together, cadonilimab and ivonescimab are now part of China’s National Reimbursement Drug List (NRDL), ensuring broader patient access and reinforcing Akeso’s commercial strength.

In its growing pipeline, AK117 (anti-CD47) entered Phase III in combination with ivonescimab for head and neck squamous cell carcinoma (HNSCC). Akeso now boasts over 20 Phase III and 40+ Phase II trials, spanning 40+ indications, solidifying its global leadership in bispecific antibody development.

Beyond oncology, Akeso is also expanding into chronic disease segments with ebronucimab (PCSK9) approved for hypercholesterolemia, and two additional NDAs for ebdarokimab (IL-12/IL-23) and gumokimab (IL-17) under review.

With 3 drugs approved and 5 new therapies under regulatory review, Akeso continues to accelerate global innovation in oncology and chronic disease therapeutics.