Commercial Operations Enter a New Phase of Growth
In 2025, Akeso achieved record commercial sales revenue of RMB3,033.1 million, a 51.48% year-on-year increase. All approved products and indications are now included in China's National Reimbursement Drug List (NRDL). The strong commercial growth in 2025 was fueled by strong clinical validation and widespread adoption by both healthcare professionals and patients.
By the end of 2025, several high-impact indications were added to the latest NRDL, including:
Ivonescimab: 1L PD-L1(+) NSCLC
Cadonilimab: 1L gastric cancer and 1L cervical cancer
Other products: Multiple indications for penpulimab, ebdarokimab and ebronucimab
With stable pricing for core first-line (1L) indications and improved hospital access, Akeso's commercial platform is positioned for a transformative 2026.
Advanced Clinical Development of IO 2.0 Bispecifics
Ivonescimab (PD-1/VEGF):
As the world's first and only approved PD-1/VEGF bispecific antibody, ivonescimab solidified its global leadership in 2025 by iterating upon existing Standards of Care (SOC) to reshape the oncology landscape. Ivonescimab has benefited approximately 70,000 patients to date.
Ivonescimab's IO 2.0 value is anchored by a series of landmark Phase III victories: in the HARMONi-2 study, ivonescimab achieved a head-to-head win against pembrolizumab in 1L PD-L1(+) NSCLC, establishing a new "chemo-free" standard. Additionally, the HARMONi-A study marked it as the first immunotherapy to reach dual PFS and OS positivity in EGFR-TKI resistant NSCLC, while HARMONi-6 demonstrated its superiority over tislelizumab (anti-PD-1 monoclonal antibody) in combination with chemotherapy in 1L squamous NSCLC, successfully overcoming traditional anti-VEGF contraindications for squamous histology.
Currently, the U.S. FDA has accepted the BLA from our partner Summit Therapeutics for ivonescimab plus chemotherapy in nsq-NSCLC following third-generation EGFR-TKI failure. As the only commercialized PD-1/VEGF bispecific globally, ivonescimab has secured two approved lung cancer indications in China (both NRDL-listed) with another sNDA under review for the first-line treatment of advanced squamous NSCLC. The Company's expansive global development program now encompasses 15 Phase III trials, including 5 global studies and 7 head-to-head studies against PD-1/L1 therapies, targeting critical 1L indications, IO-resistant, and "cold" tumors.
Cadonilimab (PD-1/CTLA-4):
Cadonilimab (PD-1/CTLA-4) is the world's first and only approved bispecific antibody of its class. With approximately 120,000 patients treated to date, it has demonstrated "all-comer" clinical benefits across multiple tumor types. Its exceptional efficacy in treating challenging cases, such as IO-resistant and "cold" tumors, has solidified its status as a cornerstone therapy in the IO 2.0 era.
Akeso is advancing 12 registrational or Phase III clinical trials for cadonilimab globally, covering more than 10 major cancer types and spanning the full treatment lifecycle and clinical scenarios. Furthermore, the Company is spearheading two international registrational studies: a head-to-head Phase III trial against nivolumab in first line gastric cancer, and a registrational trial for IO-resistant hepatocellular carcinoma (HCC). These high-efficiency global studies aim to address significant unmet medical needs, further unlocking cadonilimab's ...
