IO 2.0 + ADC 2.0 Strategy Builds a "Next-Generation" Platform with Global Competitive Edge
Key Highlights:
Final analysis of HARMONi-A Study: Ivonescimab met the overall survival (OS) endpoint, demonstrating a statistically significant and clinically meaningful OS benefit
First international Phase III HARMONi study of Ivonescimab: High concordance between international and Chinese data
Ivonescimab secures approval for first-line treatment of NSCLC (significant positive outcomes from HARMONi-2 compared to pembrolizumab)
sNDA for ivonescimab in first-line treatment of sq-NSCLC (significant positive findings from HARMONi-6 compared to tislelizumab + chemotherapy)
Global development of ivonescimab: 13 registrational/Phase III trials (8 for lung cancer + 5 for major tumors including cold tumors and IO-resistant indications)
Cadonilimab approved for first-line treatment of cervical cancer (inclusive of all patient populations), addressing global gap in immunotherapy for PD-L1 negative patients
First international registrational clinical trial for cadonilimab: second-line HCC
Global development of cadonilimab: 10 registrational/Phase III trials (including major tumors in first-line and IO-resistant indications)
Inclusion of ivonescimab and cadonilimab in National Reimbursement Drug List (NRDL)
IO2.0 + ADC2.0 strategy rapidly advancing, with global clinical development of next-generation ADCs such as AK146D1 bispecific ADC
Penpulimab receives U.S. FDA approval, validating Akeso's international development and registration capabilities
Immunology and autoimmune breakthrough: ebdarokimab (IL-12/IL-23) received market approval, with successful Phase III trials for gumokimab (IL-17) and from manfidokimab (IL-4Rα)
HONG KONG, Aug. 26, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced its 2025 interim results for the six month period ending June 30, 2025, highlighting record commercial sales in China and major global advances in its oncology and autoimmune pipelines. The company has strengthened its leadership in IO bispecific antibodies for first-line cancers, cold tumors, and IO-resistant indications, while rapidly progressing next-generation bispecific-ADC therapies. Its "IO 2.0 + ADC 2.0" strategy is accelerating changes in the global oncology treatment landscape. Outside of oncology, Akeso is set to launch its third and fourth commercial products, boosting both its commercial portfolio and market capabilities. Driven by breakthrough clinical value, Akeso continues to optimize its oncology strategies, demonstrating leadership to reshape global treatment standards and clearly outlining its international expansion.
Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso, said: "I want to sincerely thank the members of the Akeso family for their hard work, and also to say a big 'Thank You' to our partners for their strong support. Akeso has achieved historic results during this period.
First of all, in the first half of this year, we reached record commercial performance. With expanded indications for ivonescimab and cadonilimab, coupled with accelerated market access following their inclusion in the National Reimbursement Drug List (NRDL), our innovation driven commercialization has gained significant momentum.
Secondly, our 'IO 2.0 + ADC 2.0' strategy is establishing a lasting competitive advantage. Our first-in-class bispecific antibodies, cadonilimab and ivonescimab, position Akeso as a global leader in immuno-oncology bispecifics, reinforcing our pivotal role in shaping the future of cancer treatment.
We are advancing the global development of both cadonilimab and ivonescimab in first-line cancers, cold tumors, and immuno-oncology resistant settings. Together, they are being evaluated in 23 registrational/Phase III trials and in over 20 Phase II studies worldwide, highlighting our strong commitment to research and development and providing a solid foundation for global growth. Notably, ivonescimab's initial Phase III trial demonstrated a statistically significant overall survival (OS) benefit, affirming its value across multiple endpoints, including progression-free survival (PFS) and OS.
At the same time, our lead bispecific-ADC, AK146D1, and a next-generation ADC, AK138D1, have entered global early-stage clinical trials. Additional bispecific-ADC and ADC candidates are currently being developed.
Both ivonescimab and cadonilimab are first-in-class drugs that have achieved regulatory approvals. Backed by their breakthrough clinical profiles and broad indication coverage, along with our leadership in global commercialization and a robust ADC pipeline that includes bispecific and next-generation platforms, we are now fully deploying our IO2.0 + ADC2.0 strategy worldwide. This positions us to build a transformative, long-term competitive advantage across our portfolio.
Third, we are pioneering advancements in the field of autoimmune diseases and our non-oncology pipeline serves as a significant growth driver. With the recent launches of ebdarokimab (IL-12/IL-23) and ebronucimab (PCSK9), and upcoming launches of gumokimab (IL-17) and manfidokimab (IL-4Rα), alongside innovative candidates such as our IL-4R/ST2 bispecific and assets targeting neurological diseases, we are enhancing our non-oncology portfolio and broadening our competitive position globally.
Backed by progress in R&D, clinical development, commercialization, and global strategy, Akeso has entered a new stage of growth. We remain committed to pioneering innovation, delivering transformative therapies to patients, and creating shared value for healthcare providers, patient communities, investors, and our team as we become a fully integrated global biopharma."
Breakthrough IO Bispecific Antibodies Demonstrate Sustained Commercial Momentum with High-Quality Growth
In the first half of 2025, Akeso's total commercial sales, net of distribution cost increased by 49.20% from RMB939.4 million for the six months ended June 30, 2024 to RMB1,401.6 million for the six months ended June 30, 2025. The growth underscores the company's robust commercial execution and deepening market penetration.
Research and development expenses for the six months ended June 30, 2025 was RMB731.2 million. As of June 30, 2025, The company's total balance of cash, cash equivalents, time deposits, and financial products were RMB7,138.4 million.
Key Growth Drivers Include:
First-line Indication Approvals with Superior Clinical Profiles
Cadonilimab in gastric and cervical cancers, and ivonescimab in NSCLC, are addressing critical unmet needs with clinically meaningful benefits, driving rapid adoption among physicians and patients.
Enhanced Market Access via NRDL Inclusion
Inclusion in China's National Reimbursement Drug List (NRDL) for cadonilimab (recurrent/metastatic cervical cancer) and ivonescimab (EGFR-TKI resistant NSCLC) significantly expands patient access and reduces out-of-pocket burden. Focused commercial efforts and clinician education accelerated uptake across key treatment centers.
Diversified Growth from Non-Oncology Portfolio
As the approvals for ebdarokimab (IL-12/IL-23) and ebronucimab (PCSK9) have followed one after another, the company's development efforts in non-oncology areas such as autoimmune diseases and metabolic diseases are beginning to significantly contribute to the growth of our commercial franchise.
Ivonescimab Meets OS Endpoint in HARMONi-A Final OS Analysis; Demonstrates Potential to Reshape Global Treatment Landscape Across 8 Lung Cancer and 5 Other Major Tumor Indications
Ivonescimab has consistently demonstrated superior efficacy compared to current IO 1.0 therapies, with an expanding number of global clinical program that includes multiple registrational and Phase III trials across a broad spectrum of tumors. With particular focus in first-line high-incidence cancers, cold tumors, and IO-resistant indications, ivonescimab further establishes its international leadership in cancer therapeutics.
In August, Akeso announced that the final OS analysis of this clinical trial showed that ivonescimab met the OS clinical endpoint, demonstrating a statistically significant and clinically meaningful OS benefit. As the first Phase III final analysis for ivonescimab, these results not only reinforce its breakthrough value in progression-free survival (PFS), but also highlight its ability to deliver significant OS improvement, a key endpoint in global oncology drug development.
During the reporting period, an interim analysis of the first global multicenter Phase III trial (HARMONi) also demonstrated strongly positive PFS outcomes. Although statistical significance for OS was not yet reached at the time of the announcement, a promising trend toward OS benefit was observed. With 38% of the patients enrolled from regions such as Europe and North America, the intent-to-treat (ITT) survival outcomes were highly consistent with those from the China-based HARMONi-A study, supporting ivonescimab's cross-regional consistency in efficacy and safety and enhancing its global market potential.
Furthermore, following positive results from HARMONi-2—a randomized, double-blind, head-to-head Phase III trial against pembrolizumab monotherapy that led to its approval in first-line PD-L1-positive NSCLC (its second approved indication), ivonescimab plus chemotherapy has now also demonstrated significant positive outcomes in another head-to-head Phase III study against tislelizumab plus chemotherapy in first-line squamous NSCLC. This clinical outcome demonstrates that ivonescimab shows significant clinical breakthroughs, whether compared to PD-1 monotherapy, or compared to PD-1 in combination with chemotherapy (the optimal standard of care for many cancer treatments), or compared to VEGF-related therapies in the area of anti-angiogenesis. This highlights the remarkable capability of ivonescimab to make leapfrog advancements in cancer treatment.
Ivonescimab continues to validate its clinically meaningful profile and potential with a strategically expanded development program targeting key immuno-oncology settings:
Phase III trials for Lung cancer (8 registrational/Phase III trials, 4 already met primary endpoints):
First-line NSCLC, squamous and non-squamous (versus pembrolizumab + chemotherapy; global trial)
First-line squamous NSCLC (versus tislelizumab + chemotherapy)
NSCLC after progression on EGFR-TKI therapy (HARMONi-A and HARMONi studies)
First-line PD-L1-positive NSCLC (versus pembrolizumab monotherapy)
First-line PD-L1-high expressing NSCLC (versus pembrolizumab)
IO-resistant NSCLC
Consolidation therapy for limited-stage small cell lung cancer (LS-SCLC) without progression after concurrent chemoradiotherapy (cCRT)
Phase III trials for core immuno-oncology indications (first-line therapy ):
First-line biliary tract cancer (versus durvalumab + chemotherapy)
First-line PD-L1-positive head and neck squamous cell carcinoma (HNSCC) in combination with ligufalimab (anti-CD47) versus pembrolizumab
Phase III trials for cold tumors and more：
First-line triple-negative breast cancer (TNBC)
First-line MSS/pMMR colorectal cancer (representing about 95% of CRC cases)
First-line pancreatic cancer
Additional global Phase III trials are in advanced stages of planning
An extensive clinical foundation includes over 20 Phase II studies across more than 10 additional tumor types, generating compelling efficacy and safety data to enable rapid transition to further registrational studies worldwide.
Ivonescimab uniquely targets both PD-1 and VEGF, producing a synergistic anti-tumor effect. This dual mechanism not only combines the benefits of PD-1 and VEGF inhibition but also overcomes the efficacy and safety limitations of each target alone, resulting in pronounced clinical benefits. These advantages have been confirmed across multiple Phase III trials and real-world use, rapidly establishing ivonescimab as a next-generation leader in immunotherapy and anti-angiogenic therapy.
For context, pembrolizumab (anti-PD-1) is approved for over 40 oncology indications, and bevacizumab (anti-VEGF) for more than 10. Akeso is implementing a dual-path strategy to maximize the value of ivonescimab world wide: accelerating domestic commercialization and label expansion in China, while simultaneously advancing global development in partnership with Summit Therapeutics.
Cadonilimab Advances with Global Registrational Trial Launch Following Demonstration of Broad Efficacy Across 10 Major Tumor Types First-line Therapy and IO-Resistant Settings
Cadonilimab is currently approved for recurrent/metastatic cervical cancer, first-line cervical cancer, and first-line gastric cancer, addressing significant unmet needs across multiple oncology indications. As the world's first approved immuno-oncology bispecific antibody, its breakthrough clinical value has been consistently demonstrated across numerous clinical studies and real-world applications.
Robust evidence-based medical data confirms that cadonilimab delivers clinical benefit across a broad spectrum of patient populations, showing superior efficacy regardless of PD-L1 expression status. Furthermore, cadonilimab has exhibited significant clinical advantages over current standard therapies in multiple IO-resistant tumors and cold tumors that respond poorly to existing PD-1/L1 inhibitors.
The benefits of cadonilimab stem from its unique ability to simultaneously target both PD-1 and CTLA-4, resulting in a synergistic anti-tumor effect. This innovative mechanism not only leverages the therapeutic advantages of both targets but also addresses the efficacy and safety limitations traditionally associated with them, culminating in significant clinical value. Notably, cadonilimab effectively overcomes the efficacy constraints often encountered with the toxicity of CTLA-4 monotherapies. These compelling advantages have been validated across multiple Phase III clinical trials and in real-world applications, positioning cadonilimab as a transformative advancement in the landscape of current immunotherapies.
Cadonilimab is currently being evaluated in 10 global registrational/Phase III trials spanning first-line indications in major tumors, cold tumors, and IO-resistant diseases. Beyond its already approved indications (recurrent/metastatic cervical cancer, first-line cervical cancer, first-line gastric cancer), ongoing studies include:
Combination therapy with pulocimab (anti-VEGFR-2) in PD-1-resistant gastric cancer (phase III)
Perioperative treatment for resectable gastric cancer (phase III)
First-line treatment of PD-L1-negative NSCLC (versus PD-1+ chemotherapy)(phase III)
Consolidation therapy after concurrent/sequential chemoradiation in NSCLC (versus PD-L1 inhibitor) (phase III)
Adjuvant therapy after hepatocellular carcinoma (HCC) resection (phase III)
Intermediate-stage HCC (phase III)
Global multicenter registrational Phase II trial is underway for the treatment of second-line HCC
Notably, the first global multicenter registrational study of cadonilimab in combination with lenvatinib for the treatment of second-line HCC has recently been initiated (COMPASSION-36). This represents a significant milestone in its international development and regulatory pathway. The study aims to further validate cadonilimab's potential to overcome the limitations of single-target immunotherapies in global clinical practice, while also demonstrating the synergistic anti-tumor effect achieved through the dual targeting of PD-1 and CTLA-4. Additional multinational registrational and Phase III trials are currently in preparation.
While advancing cadonilimab's global development independently, Akeso remains open to strategic collaborations to integrate worldwide resources and accelerate its international expansion, maximizing global patient reach and therapeutic value.
Global Clinical Development of Bispecific ADCs,
Leading a Transformative "IO 2.0 + ADC 2.0" Strategy in Oncology
As IO-ADC combinations emerge as a pivotal direction in cancer therapy, Akeso as the only company globally with two approved immuno-oncology bispecific antibodies (cadonilimab and ivonescimab), is leveraging its strong leadership in the IO field to advance a next-generation pipeline of ADCs, bispecific ADCs, and dual-payload ADCs. Building on extensive international experience in bispecific/multispecific development, Akeso is combining its IO bispecifics with novel ADC platforms to create multidimensional, iterative treatment strategies aimed at redefining the global oncology landscape.
The company has advanced its novel bispecific ADC targeting Trop2/Nectin4 (AK146D1) , and its differentiated novel HER-3 ADC (AK138D1) into global clinical development. Studies evaluating AK138D1 and AK146D1 in combination with cadonilimab or ivonescimab are currently in preparation.
Additional next-generation internally developed ADCs, bispecific ADCs, and dual-payload ADCs are set to enter clinical trials in the future.
Furthermore, ivonescimab and cadonilimab are also being widely explored in combination studies with ADCs from industry partners.
Notably, Akeso's proprietary differentiated PD-1 inhibitor, penpulimab, has received approval from the U.S. FDA, making it the company's first internally developed innovative drug to be approved in the United States, and the first biologic entirely led (from R&D and clinical development to manufacturing and regulatory submission) by a Chinese company to achieve U.S. FDA approval.
During the reporting period, other oncology assets also achieved key milestones:
Akeso's in-house developed next-generation anti-CD47 antibody, ligufalimab, is being evaluated in multiple Phase III trials alongside cadonilimab and ivonescimab across several tumor types. Global clinical development of ligufalimab in hematologic malignancies is also ongoing
The in-house developed pulocimab (VEGFR-2) is being evaluated in several Phase III trials in combination with cadonilimab and ivonescimab
Two Additional Phase III Successes in Autoimmune Therapies Accelerate Non-Oncology Commercial Growth
Beyond its oncology portfolio, Akeso has achieved significant milestones in autoimmune diseases with its in-house developed novel therapeutics:
Ebronucimab (anti-PCSK9) has been approved in China for hypercholesterolemia, which affects approximately 110 million patients in China
Ebdarokimab (anti-IL-12/IL-23) is approved in China for the treatment of psoriasis, a condition affecting around 6.7 million patients in China
Gumokimab (anti-IL-17) has had its New Drug Application (NDA) accepted by NMPA for moderate-to-severe plaque psoriasis
Additionally, gumokimab has achieved positive results in a Phase III trial for active ankylosing spondylitis, and manfidokimab (anti-IL-4Rα) has also reported Phase III success in atopic dermatitis. NDA submissions for these indications are currently underway
The successive approvals and advanced development of these four non-oncology drugs enable Akeso to address diverse treatment needs across chronic, autoimmune diseases with large patient populations, creating a synergistic product portfolio that significantly enhances the company's competitiveness in the immunology sector.
With further global innovations such as the IL-4R/ST2 bispecific antibody (AK139) and candidates targeting neurological diseases advancing through multi-indication development, Akeso continues to strengthen its non-oncology pipeline with first-in-class innovation.
Moving forward, Akeso remains committed to pioneering novel therapeutics through original innovation. We will continue to develop medicines with global competitiveness, aiming to benefit patients worldwide and grow into a leading global biopharmaceutical company.
About Akeso
Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.
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