HONG KONG, March 26, 2026 /PRNewswire/ -- Akeso, Inc. $(09926)$ ("Akeso" or the "Company") announced its 2025 annual results, highlighting a year of comprehensive, strategic leaps across all facets of its business.

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 global therapeutic value.

Oncology Therapy Matrix Continues to Expand

Akeso is pioneering the IO 2.0 + ADC 2.0 strategy, expanding its portfolio from bispecifics into trispecifics and TCE platforms. the Company is fast-tracking the global development of its next-gen ADCs, such as the bispecific Trop2/Nectin4 AK146D1, and the HER3 AK138D1. By combining these with its core IO assets (cadonilimab and ivonescimab), Akeso aims to address the narrow therapeutic windows associated with traditional ADCs. With AK150 (trispecific) now in the clinic and more trispecific/multispecific antibodies and TCE bispecific/multispecific antibodies approaching clinical entry, Akeso is rapidly building a formidable, next-generation oncology matrix.

Paradigm Shift in Bispecific Excellence: Continuous Expansion of the Oncology Portfolio

Akeso is methodically extending its IO 2.0 leadership into the emerging ADC 2.0 landscape, thereby operationalizing its integrated "IO 2.0 + ADC 2.0" platform thesis while systematically advancing bispecific antibody expertise into higher order trispecific/multispecific antibodies and TCE platforms. In the area of IO, Akeso remains the sole global player with two approved immuno-oncology bispecifics, a distinction that confers both first-mover clinical validation and a proprietary data moat in dual-check point/dual-pathway blockade. On the ADC front, the Company's next-generation candidates, notably bispecific ADC AK146D1 and novel ADC AK138D1, are purpose-engineered to overcome the narrow therapeutic window that chronically plagues current ADCs, advancing the field into ADC 2.0.

Phase II trials combining these proprietary ADCs with cadonilimab and ivonescimab are now underway, with global expansion planned. Both IO bispecifics are also being explored broadly with external high-potential ADCs. Meanwhile, the Company's first trispecific antibody, AK150, is in clinical development, with more trispecific/multispecific and TCE assets approaching the clinic.

Immune and CNS Diseases Enter the Dual-Target Era

Beyond building global competitiveness in oncology, Akeso has created a powerful new growth engine in immune-related diseases. Leveraging its bispecific and multispecific antibody platforms, the Company is advancing a pipeline of novel candidates in autoimmune, respiratory, allergy, and CNS indications, including AK139, AK152 (siRNA), KF111 (siRNA), and KF115 (siRNA), alongside commercial-stage products like ebdarokimab, gumokimab and manfidokimab. This layered portfolio is rapidly strengthening Akeso's global presence beyond oncology.

AI-Powered R&D and Cutting-Edge Platforms

Building atop its globally competitive command in monoclonal and bispecific antibody development, Akeso has executed a deliberate expansion into frontier therapeutic modalities by embedding AI end-to-end across the entire R&D and manufacturing continuum - from discovery and cell-line/process development through to smart manufacturing. The outcome is a tightly orchestrated portfolio of differentiated platforms: the Tetrabody antibody technology platform, the AI-powered drug R&D platform, the Dual-Shield ADC technology platform, the Dual-Lock T-cell engager (TCE) technology platform, the Tissue-Smart siRNA/mRNA technology platform, and the cell therapy technology platform. These assets collectively solidifies Akeso's global innovation edge, unlocking 0-to-N breakthroughs across multiple high-barrier domains where conventional therapeutic modalities have historically stalled.

Akeso continues to iterate and scale its AI-powered, integrated drug discovery platform, which now provides comprehensive coverage across the entire R&D lifecycle for both antibody and nucleic acid therapeutics, while extending into additional frontier modalities. At its core lies a proprietary AI technology matrix that fuses high-precision structure prediction, immunogenicity prediction, fully automated humanization, and one-step sequence optimization. This closed-loop, data-rich architecture enables end-to-end precise engineering from sequence design to clinical development, significantly accelerating the efficient and high throughput development of innovative therapies.

Dr. Michelle Xia, Founder, Chairwoman, President, and CEO of Akeso, commented:

"2025 marked a definitive strategic leap for Akeso across commercialization, global clinical expansion, and our broadening multi-platform innovation ecosystem. We achieved over 50% sales revenue growth. This success provides a powerful springboard for continued commercial and clinical execution in 2026.

We are now pioneering a shift in therapeutic paradigms. Leveraging our leadership in IO bispecifics, we are expanding into 'IO 2.0 + ADC 2.0,' including bispecific ADCs, trispecifics, and TCE platforms. Beyond oncology, we are bringing the immense therapeutic benefit of bispecific antibodies to immunology, respiratory, and CNS diseases, all powered by our integrated AI discovery engine.

Our vision to bring transformative and life saving medicine to every patient on Earth is coming to fruition. With over ten products in international trials, including studies that includes ivonescimab and cadonilimab, we are advancing our mission to deliver world-class medicines to patients worldwide. By integrating global talent, capital, and R&D resources, and integrating AI into our research and development efforts, we are building a robust institutional framework to sustain Akeso's long-term leadership in innovation in the global biopharmaceutical industry."

About Akeso

(MORE TO FOLLOW) Dow Jones Newswires

March 26, 2026 23:54 ET (03:54 GMT)