Akeso, Inc.

Akeso, Inc. is a publicly listed Chinese biopharmaceutical company dedicated to the research, development, manufacturing, and commercialization of innovative antibody drugs. Headquartered in Zhongshan, Guangdong, China, the company's mission is to develop first-in-class and best-in-class new drugs, providing affordable therapeutic antibodies to patients worldwide, with the aim of becoming a leading global biopharmaceutical enterprise.

The company maintains a robust pipeline of over 50 innovative assets, with 27 candidates currently in clinical trials, including 15 bispecific/multispecific antibodies and bispecific antibody-drug conjugates (ADCs). Key approved products include cadonilimab (a PD-1/CTLA-4 bispecific antibody), ivonescimab (a PD-1/VEGF bispecific antibody), penpulimab (a PD-1 inhibitor), ebronucimab (a PCSK9 inhibitor), and ebdarokimab (an IL-12/IL-23 inhibitor). Akeso focuses on addressing unmet clinical needs in major diseases, particularly within oncology, autoimmune diseases, inflammation, and metabolic disorders.

Led by co-founder, Chairwoman, President, and CEO Michelle Xia, Akeso has achieved significant milestones in its market positioning. Notably, its ivonescimab has received multiple authoritative updates and upgrades in the 2026 Chinese Society of Clinical Oncology (CSCO) Guideline for Non-Small Cell Lung Cancer (NSCLC), solidifying its status as a new standard of care. In April 2025, the U.S. Food and Drug Administration (FDA) approved Akeso's Penpulimab, marking the company's first product to receive U.S. regulatory approval. Akeso is also advancing its ADC strategy, with its first ADC drug, AK138D1, entering Phase I clinical trials in Australia in February 2025. The company is recognized as the only global biopharmaceutical firm with two approved bispecific checkpoint antibodies for cancer immunotherapy.

Latest updates

Akeso's Ivonescimab Gains Ground in China's NSCLC Treatment Guidelines

Event summary

  • Akeso's ivonescimab, a PD-1/VEGF bispecific antibody, received Class I recommendations in the 2026 CSCO NSCLC guidelines for first-line treatment of both squamous and non-squamous NSCLC with PD-L1 TPS ≥1%.
  • The combination of ivonescimab and chemotherapy received a new Class II recommendation for first-line treatment of squamous NSCLC, pending regulatory review.
  • Ivonescimab has been demonstrated in dozens of clinical trials involving over 70,000 patients.
  • The drug is already approved in China and included in the National Reimbursement Drug List (NRDL).

The big picture

This guideline upgrade significantly strengthens Akeso's position in the rapidly growing Chinese immuno-oncology market, which is increasingly important as global markets become saturated. The Class I recommendations provide a substantial boost to ivonescimab’s adoption and reimbursement prospects, potentially accelerating revenue growth. However, the competitive landscape remains intense, and Akeso will need to defend its market share against established players and emerging therapies.

What we're watching

Regulatory Approval
The approval timeline for the combination therapy with chemotherapy will be critical for Akeso's near-term revenue projections and market share gains in squamous NSCLC.
Market Adoption
The extent to which oncologists and patients embrace ivonescimab as a standard of care, despite existing PD-1 inhibitors, will determine the drug's long-term commercial success.
Competition
The emergence of other bispecific antibodies or novel immunotherapies could erode ivonescimab’s market position, necessitating continued innovation and clinical data generation.

Akeso's Cadonilimab Shows Promise in Pancreatic Cancer, Bolstering Immunotherapy Portfolio

Event summary

  • Akeso presented Phase II data (COMPASSION-26 study) for cadonilimab, a PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy for first-line treatment of advanced pancreatic ductal adenocarcinoma (PDAC).
  • The combination demonstrated a median progression-free survival (PFS) of 11.1 months and a median overall survival (OS) exceeding 23 months in patients with locally advanced disease.
  • Landmark survival rates included a 12-month OS rate of 91.7% and a 24-month OS rate of 44.1% in the locally advanced disease subgroup.
  • The objective response rate (ORR) was 33.9% and the disease control rate (DCR) reached 96.4% across the overall study population.
  • Cadonilimab received marketing approval in 2022 and is described as a 'cornerstone therapy' in tumor immunotherapy 2.0.

The big picture

Pancreatic cancer remains a devastating disease with limited treatment options, representing a significant unmet medical need. Akeso's cadonilimab combination offers a potential breakthrough, but the long-term durability and broader applicability of these results require further validation. The success of this therapy could solidify Akeso's position as a leader in the burgeoning bispecific antibody market, which is attracting significant investment and competition.

What we're watching

Regulatory Pathway
The strength of these Phase II results will likely accelerate discussions with regulatory bodies, but approval hinges on demonstrating similar efficacy in larger, Phase III trials.
Competitive Landscape
While cadonilimab is the first approved bispecific antibody for cancer, other companies are aggressively pursuing similar therapies, and Akeso must demonstrate sustained differentiation.
Commercialization
The high cost of immunotherapy treatments will necessitate a robust patient access strategy and potentially value-based pricing models to ensure widespread adoption in key markets.

Akeso's Cadonilimab Combo Shows Promise in NSCLC, Bolsters Immunotherapy Portfolio

Event summary

  • Akeso presented updated Phase Ib/II data at ELCC 2026 for cadonilimab in combination with anlotinib and docetaxel.
  • The study included patients with advanced NSCLC who progressed after prior PD-(L)1 inhibitor therapy, with a median follow-up of 21.45 months.
  • The combination regimen demonstrated a median progression-free survival (PFS) of 7.0 months and a disease control rate (DCR) of 95.2%.
  • ctDNA clearance after the first treatment cycle correlated with a median PFS of 9.1 months.

The big picture

Akeso's cadonilimab, already approved as a bispecific antibody, is demonstrating versatility in treating immunotherapy-resistant cancers. This Phase Ib/II data expands its potential beyond initial indications, addressing a significant unmet need in NSCLC. The combination approach highlights a broader trend in oncology towards more complex therapeutic regimens to overcome resistance mechanisms, but also introduces challenges in terms of safety and patient management.

What we're watching

Regulatory Approval
The success of this combination therapy hinges on securing regulatory approvals beyond its current indications, particularly given the competitive landscape in NSCLC.
Commercialization
Akeso's ability to effectively commercialize this regimen will depend on demonstrating long-term efficacy and managing the complexity of a triple combination therapy.
Competitive Dynamics
The emergence of other immunotherapy-resistant NSCLC treatments will dictate whether this combination can establish a sustainable market share and pricing power.

Akeso's Lung Cancer Drug Shows Quality of Life Gains Over Pembrolizumab

Event summary

  • Akeso presented health-related quality of life (HRQoL) data from the Phase III HARMONi-2 study at the 2026 European Lung Cancer Congress (ELCC).
  • Ivonescimab, Akeso's PD-1/VEGF bispecific antibody, demonstrated a median progression-free survival (PFS) of 11.14 months versus 5.82 months for pembrolizumab.
  • The study showed improvements in global health status, physical function, and emotional function in patients treated with ivonescimab, alongside reductions in cough, hemoptysis, and dyspnea.
  • Ivonescimab was approved in China in 2025 for first-line treatment of PD-L1-positive NSCLC.

The big picture

Akeso's data highlights the growing importance of patient-reported outcomes (PROs) in oncology drug development, as quality of life increasingly becomes a key factor in treatment decisions. The company's first-in-class bispecific antibody demonstrates a potential shift away from traditional chemotherapy regimens, offering a more targeted and potentially less toxic treatment option for NSCLC patients. This success positions Akeso as a rising competitor in the global lung cancer therapeutics market, which is projected to reach billions in revenue within the next decade.

What we're watching

Regulatory Approval
The success of ivonescimab in China, coupled with these positive HRQoL data, will likely accelerate regulatory review timelines in other major markets, but acceptance will depend on a holistic assessment of benefit-risk.
Market Adoption
The demonstrated quality of life benefits could be a key differentiator for ivonescimab, potentially driving faster adoption among patients and physicians, but will require effective communication and patient education.
Competitive Landscape
Akeso's success will put pressure on other biopharmaceutical companies developing bispecific antibodies and other novel therapies for NSCLC, potentially leading to increased competition and pricing pressures.

Akeso's IO Bispecifics Drive 51% Revenue Surge, Expanding Oncology Portfolio

Event summary

  • Akeso reported RMB3,033.1 million (approximately $420 million USD) in commercial sales revenue for 2025, a 51.48% year-over-year increase.
  • All approved Akeso products and indications are now included in China's National Reimbursement Drug List (NRDL).
  • Key clinical trial results, including head-to-head wins for Ivonescimab against pembrolizumab and superiority over tislelizumab, have bolstered commercial adoption.
  • Akeso is expanding its oncology portfolio beyond bispecifics into trispecifics and ADCs, with AK150 (trispecific) currently in clinical development.

The big picture

Akeso's rapid revenue growth and clinical successes underscore the increasing demand for novel immuno-oncology therapies in China and globally. The company's strategic pivot towards combining bispecifics with ADCs and trispecifics represents a bet on next-generation cancer treatments, aiming to overcome limitations of existing therapies. Akeso's aggressive expansion into immune-related diseases further diversifies its pipeline and reduces reliance on oncology.

What we're watching

Regulatory Approval
The approval timeline for the sNDA for Ivonescimab in China will be a key indicator of the drug's long-term commercial potential.
ADC Integration
The success of Phase II trials combining Akeso's bispecific ADCs with cadonilimab and ivonescimab will determine the viability of its 'IO 2.0 + ADC 2.0' strategy.
Global Expansion
The pace of global clinical expansion, particularly in the US, will be crucial for Akeso to realize its full market potential.

Akeso Advances ADC-IO Combination Trials, Bolstering China Oncology Play

Event summary

  • Akeso received clearance from the CDE/NMPA to initiate Phase II clinical trials for AK146D1 (Trop2/Nectin4 ADC) and AK138D1 (HER3 ADC).
  • The Phase II trials will combine the ADCs with Akeso’s IO 2.0 bispecific antibodies, cadonilimab (PD-1/CTLA-4) and ivonescimab (PD-1/VEGF).
  • The trials will also evaluate AK117 (anti-CD47) and AK109 (anti-VEGF) within a broader combination strategy.
  • Akeso is positioning this as an acceleration of its 'IO 2.0 + ADC 2.0' platform into mid-stage development.

The big picture

The convergence of immuno-oncology and antibody-drug conjugates represents a significant shift in oncology treatment, aiming to overcome limitations of single-modality therapies. Akeso’s strategy to combine its proprietary IO 2.0 bispecific antibodies with next-generation ADCs positions it to capitalize on this trend, particularly within the large and growing Chinese market. Akeso’s claim of being the only company with two approved checkpoint bispecific antibodies provides a potential competitive advantage, but success hinges on demonstrating clinical efficacy and navigating regulatory hurdles.

What we're watching

Clinical Efficacy
The initial Phase II data for AK146D1 and AK138D1, particularly regarding response rates and duration of response, will be critical in validating the combination approach and guiding further development.
Regulatory Pathway
The speed and rigor of the NMPA’s review process for these combination therapies will influence Akeso’s timeline for commercialization and its competitive positioning within China’s rapidly evolving oncology market.
Competitive Landscape
How other companies, particularly those with established ADC or IO platforms, respond to Akeso’s progress in combining these modalities will shape the competitive dynamics within the Chinese oncology space.

Akeso's Cadonilimab Shows Near-Complete Remission in Advanced Cervical Cancer

Event summary

  • Akeso's cadonilimab demonstrated a 100% 24-month overall survival (OS) rate in patients with recurrent/metastatic cervical cancer (R/M CC) who achieved a complete response (CR) in a Phase II clinical trial.
  • The study, presented at ESGO 2026, included 99 efficacy-evaluable patients, with a median follow-up of 26.5 months.
  • Cadonilimab’s median progression-free survival (PFS) in CR patients was not reached, with a 12-month PFS rate of 84.6%.
  • The drug is already approved in China for first-line gastric cancer, first-line cervical cancer, and recurrent/metastatic cervical cancer.

The big picture

Akeso’s cadonilimab represents a significant advancement in immunotherapy for cervical cancer, a disease with limited treatment options and poor prognosis. The near-complete remission observed in CR patients suggests a potential paradigm shift in treatment approaches, particularly for patients who have failed prior platinum-based chemotherapy. This success underscores the growing importance of bispecific antibodies and ‘IO 2.0’ strategies that overcome limitations of existing checkpoint inhibitors.

What we're watching

Regulatory Approval
The exceptional survival data will likely accelerate cadonilimab’s regulatory review in other markets, but acceptance will hinge on replicating these results in larger, global trials.
Commercial Adoption
The drug’s success will depend on clinicians’ willingness to adopt a novel bispecific antibody, particularly given existing standard-of-care treatments.
Pipeline Expansion
Akeso’s strategy of expanding cadonilimab’s indications across various cancer types and treatment settings will determine the drug’s long-term revenue potential.

Akeso, Inovio Partner on GBM Therapy in Adaptive Trial

Event summary

  • Akeso (HKEX: 9926.HK) and Inovio (NASDAQ: INO) are collaborating on a Phase II clinical trial to evaluate Akeso’s cadonilimab in combination with Inovio’s INO-5412 for glioblastoma (GBM).
  • The trial will be conducted within the INSIGhT adaptive platform trial sponsored by the Dana-Farber Cancer Institute.
  • Dosing in the combination therapy trial is expected to begin in the second half of 2026.
  • Cadonilimab is already approved in China for several cancer indications and is part of over 11 Phase III/registration clinical studies.

The big picture

The collaboration reflects the growing trend of combining immunotherapy approaches to overcome treatment resistance in aggressive cancers like GBM. Akeso’s established bispecific antibody platform, coupled with Inovio’s DNA immunotherapy, represents a strategic bet on a synergistic therapeutic effect. The INSIGhT adaptive trial design aims to accelerate the evaluation of this combination, a crucial factor given the limited treatment options and high unmet need in GBM.

What we're watching

Clinical Efficacy
The success of the INSIGhT trial will hinge on demonstrating a meaningful survival benefit for GBM patients, a notoriously difficult-to-treat cancer, and will be a key catalyst for both Akeso and Inovio.
Regulatory Pathway
Given cadonilimab’s existing approvals in China, the regulatory pathway in other markets will be crucial; the INSIGhT trial’s data will heavily influence future submissions.
Commercialization
The partnership's ability to navigate the complexities of commercializing a novel combination therapy, particularly in a high-cost oncology setting, will determine the long-term financial viability of the collaboration.

Akeso Advances Dual-Target Antibody into Phase II Trials Across Respiratory, Autoimmune Spectrum

Event summary

  • Akeso (HKEX: 9926.HK) received approval from the National Medical Products Administration to initiate Phase II clinical trials for AK139 in China.
  • AK139, a first-in-class IL-4Rα/ST2 bispecific antibody, will be tested across seven indications: COPD, asthma, urticaria, allergic rhinitis, chronic rhinosinusitis, atopic dermatitis, and prurigo nodularis.
  • The antibody targets both the IL-4/IL-13 and IL-33/ST2 pathways, demonstrating synergistic efficacy in preclinical studies.
  • Akeso’s pipeline includes other novel autoimmune therapies like ebdarokimab, gumokimab, and manfidokimab.

The big picture

Akeso's advancement of AK139 represents a strategic shift towards dual-target therapies for chronic inflammatory diseases, addressing a significant unmet need in a market increasingly demanding more effective treatments. The company's focus on bispecific antibodies, leveraging its proprietary Tetrabody platform, positions it to capitalize on the growing trend of precision medicine and potentially disrupt existing treatment paradigms. This expansion beyond oncology into autoimmune diseases demonstrates a deliberate diversification strategy for Akeso, aiming to broaden its revenue streams and market reach.

What we're watching

Clinical Efficacy
The Phase II trials will be critical in determining whether AK139’s synergistic mechanism translates to meaningful clinical benefit across the diverse range of indications, and whether the observed preclinical efficacy holds true in human patients.
Regulatory Pathway
The speed of AK139’s progression through China’s regulatory system will be a key indicator of broader acceptance of novel bispecific therapies, and could influence the development timelines for similar candidates from other companies.
Competitive Landscape
The success of AK139 could accelerate the development of other dual-target therapies in respiratory and autoimmune diseases, intensifying competition within these markets and potentially reshaping treatment paradigms.

Akeso Secures Fifth NMPA Breakthrough Designation for Biliary Cancer Therapy

Event summary

  • Akeso received its fifth Breakthrough Therapy Designation (BTD) from the NMPA for ivonescimab, a bispecific antibody, in combination with chemotherapy for first-line treatment of advanced biliary tract cancer (BTC).
  • The Phase III clinical study (AK112-309/HARMONi-GI1) evaluating ivonescimab plus chemotherapy versus durvalumab plus chemotherapy has completed patient enrollment.
  • Phase 1b/II data showed ivonescimab plus chemotherapy achieved a 63.6% Objective Response Rate (ORR) and 100% Disease Control Rate (DCR), with mPFS of 8.5 months and mOS of 16.8 months.
  • This BTD follows four previous designations from the NMPA, three for lung cancer and one for triple-negative breast cancer (TNBC).

The big picture

Akeso's repeated BTD designations highlight the growing importance of China's regulatory pathway for innovative therapies. The company's Tetrabody platform appears to be generating promising candidates across multiple cancer types, but the Phase III trial results will be the ultimate determinant of commercial success. The competition in the BTC space is intensifying, and Akeso’s ability to demonstrate a meaningful clinical advantage will be crucial for capturing market share.

What we're watching

Regulatory Speed
The accelerated review process afforded by the BTD will be a key indicator of the NMPA's commitment to innovative therapies and could set a precedent for future approvals.
Phase III Results
The success of the ongoing Phase III trial, particularly in demonstrating superiority over durvalumab plus chemotherapy, will be critical for ivonescimab's commercial viability in China.
Market Adoption
How quickly physicians and patients adopt ivonescimab, even with accelerated approval, will depend on its perceived efficacy and safety profile relative to existing treatment options.

Akeso's Ivonescimab Gains Prominence in FirstWord Pharma's 2026 Forecast

Event summary

  • Akeso's ivonescimab, a PD-1/VEGF bispecific antibody, has been included in FirstWord Pharma's 'The Drugs That Will Shape 2026' list.
  • Ivonescimab is the only drug on the list originating from independent R&D of a Chinese pharmaceutical company.
  • The list features other prominent therapies from companies like Eli Lilly, AstraZeneca, Novartis, and Moderna/Merck.
  • Akeso has over 50 innovative assets in its pipeline, with 26 currently in clinical trials.

The big picture

Akeso's inclusion in FirstWord Pharma's list signals growing recognition of Chinese pharmaceutical innovation on the global stage. The company's focus on bispecific antibodies and its 'IO 2.0+' strategy position it to capitalize on the evolving immuno-oncology market, but success hinges on navigating complex regulatory pathways and demonstrating clinical superiority against established therapies. This inclusion validates Akeso's strategy of global expansion and collaboration, but also highlights the inherent risks associated with drug development and commercialization.

What we're watching

Regulatory Scrutiny
Increased scrutiny from regulatory bodies in both China and international markets will be critical for ivonescimab's approval timeline and commercial success.
Competitive Landscape
The competitive landscape for immuno-oncology therapies remains intense, and Akeso must demonstrate ivonescimab's differentiated efficacy and safety profile to gain market share.
IO 2.0+
Akeso's stated focus on 'IO 2.0+' and expansion into autoimmune and neurological disorders will determine the breadth of its future pipeline and revenue streams beyond oncology.

Akeso Secures NMPA Review for Gumokimab in Ankylosing Spondylitis

Event summary

  • Akeso (9926.HK) received acceptance for review of its supplemental New Drug Application (sNDA) for gumokimab (AK111) for active ankylosing spondylitis (AS) by the NMPA’s CDE.
  • China’s AS patient population is estimated at approximately 4 million.
  • This is the second NDA acceptance for gumokimab, following a prior acceptance for psoriasis treatment in January 2025.
  • The acceptance is based on positive Phase III clinical trial results (AK111-303) demonstrating efficacy and symptom alleviation.

The big picture

Akeso’s success in China’s biopharmaceutical market is increasingly important as the company seeks to diversify beyond its Hong Kong listing. The acceptance of gumokimab’s NDA underscores the growing demand for novel therapies in China, but also highlights the challenges of navigating the country’s regulatory environment and reimbursement processes. Akeso's focus on innovative therapies, including bispecific antibodies, positions it to capitalize on this demand, but execution risks remain significant.

What we're watching

Regulatory Timeline
The speed of NMPA review will be a key indicator of Akeso’s prospects in the Chinese market, particularly given the competitive landscape for biologics.
Commercialization
The success of gumokimab will depend on Akeso’s ability to secure reimbursement and distribution within China’s complex healthcare system.
Pipeline Momentum
Akeso’s continued advancement of its broader pipeline, including bispecific antibodies like AK139 and AK152, will be crucial for long-term growth and diversification.
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