Akeso's 2024 Results: Strengthening Global Competitiveness and Transforming the Treatment Landscape with Bispecific Antibodies
Key Highlights:
Global first "immuno + anti-vascular" bispecific antibody approved: ivonescimab for EGFR-TKI resistant nsq-NSCLC. Phase III HARMONi study topline data expected mid-2025 (FDA FTD).
ivonescimab outperforms pembrolizumab in Phase III study for first-line PD-L1+ NSCLC: mPFS HR=0.51; sNDA under priority review.
Cadonilimab approved for first-line gastric cancer: Fills immunotherapy gap for patients with low or negative PD-L1 expression.
Cadonilimab's sNDA for first-line cervical cancer accepted by NMPA.
New commercial milestones: cadonilimab and ivonescimab added to the National Reimbursement Drug List (NRDL).
AK117 (CD47) enters Phase III trials: ivonescimab combined with AK117 for first-line HNSCC treatment, compared with pembrolizumab.
Cadonilimab and ivonescimab: Over 20 Phase III and 40+ Phase II trials ongoing, covering 40+ indications.
"IO+ADC" 2.0 strategy gaining momentum: First self-developed ADC and bispecific ADC enter clinical trials.
Non-oncology expansion: ebronucimab (PCSK9) approved, NDAs for ebdarokimab (IL-12/IL-23) and gumokimab (IL-17) under review.
3 drugs approved, 5 new drugs with 5 indications under regulatory review.
HONG KONG, March 30, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) ("Akeso", "the Company") released its 2024 annual report, emphasizing the company's key achievements in drug research, clinical development, and commercialization.
In 2024, Akeso achieved key success in antibody therapy research and development. The approval of new indications for cadonilimab and the launch of first-in-class drugs like ivonescimab expanded the company's footprint in major solid tumors, including lung and gastric cancers. Akeso continues to challenge current standard of care with head-to-head trials against pembrolizumab and other therapies, while advancing novel treatments such as anti-CD47 monoclonal antibody, antibody drug conjugates ("ADCs") and bispecific ADCs. The company also achieved major milestones in commercialization and patient access, with products included in national insurance directories. Currently, over 25 registrational and Phase III clinical trials are actively progressing.
On the commercial front, Akeso's adjustments in drug pricing and optimization of its commercial systems led to new drug sales revenue surpassing RMB 2 billion in 2024, a 25% year-on-year increase. The company continues to reduce operating losses, with an EBITDA loss of 225 million RMB in 2024.
Dr. Xia Yu, Founder, Chairwoman, President, and CEO of Akeso Biopharma:
"We are thrilled to have reached historic milestones in our innovative drug development in 2024. The approval of several globally competitive products and breakthroughs in advanced therapies have strengthened our global competitiveness in biopharmaceutical innovation.
Notably, our first-in-class bispecific antibodies, cadonilimab and ivonescimab, have been approved for commercial sales and included in China's NRDL. This significantly improves drug accessibility, reduces patient burdens, and fulfills a key strategic goal in our domestic commercialization efforts. In clinical development, cadonilimab and ivonescimab are currently in over 20 registrational/Phase III clinical trials globally, establishing a strong presence in first-line treatments for a wide range of high-incidence cancers. Additionally, more than 40 Phase II trials are ongoing, further strengthening our leadership in global cancer immunotherapy.
We've also made key advances in novel therapies, with ligufalimab (anti-CD47 mAb) moving to Phase III for solid tumors, and progress in next-gen ADCs, bispecific ADCs, and autoimmune bispecific antibodies.
These achievements have expanded our oncology pipeline and strengthened our global expansion strategy with a comprehensive 'IO 2.0+' combination therapy platform."
Akeso's Bispecific Antibody Clinical Portfolio Continues to Expand, Demonstrating Global Leadership in Next-Generation Tumor Immunotherapy
In 2024, Akeso continued to focus and make progress on research and clinical development. The accomplishments from these efforts include :
3 novel drugs approved for ...
