Annuncio • Sep 08

Akeso, Inc. Announces HARMONi-A Study Conducted in China Reaches OS Clinical Endpoint

Akeso, Inc. announced that its global partner, Summit Therapeutics Inc. announced the updated overall survival (OS) results from the global Phase III HARMONi clinical trial of ivonescimab, a novel PD-1/VEGF bispecific antibody, at the Presidential Symposium in the 2025 World Conference on Lung Cancer (WCLC). Longer-term follow-up of western patients showed improving, favorable trend in OS, yielding a hazard ratio (HR) of 0.78 and a nominal p-value of 0.0332. Meanwhile, Akeso recently announced that the HARMONi-A study conducted in China has also recently reached the OS clinical endpoint, achieving clinically meaningful and statistically significant OS benefit. The OS data from this study will be presented at upcoming academic conferences. The results from the first international multi-center Phase III HARMONi study of ivonescimab, along with those from the Phase III HARMONi-A study conducted in China, demonstrated consistent and robust clinical efficacy in both progression-free survival (PFS) and OS. These findings provide strong evidence that ivonescimab not only offers significant advantages in terms of rapid onset of action and effective disease control in cancer treatments but also provide survival benefits to patients. The data further support ivonescimab's consistent efficacy and safety across diverse global populations, including both international and Chinese cohorts, reinforcing its potential for broad therapeutic benefit for cancer patients worldwide. Approximately 38% of patients were recruited from western countries. The trial results were presented by Jonathan Goldman, MD, Professor of Medicine at UCLA in the Hematology/Oncology Division, UCLA Director of Clinical Trials in Thoracic Oncology, Associate Director of Early Drug Development, and Chair of University of California Lung Cancer Consortium. Clinically Meaningful Efficacy: As previously disclosed, ivonescimab in combination with chemotherapy showed a positive trend in OS in the primary analysis without achieving a statistically significant benefit with a hazard ratio of 0.79 (95% CI: 0.62 – 1.01; p=0.057). The statistical analysis plan for the study required a p-value of 0.0448 in order to achieve statistical significance at the time of the primary analysis of overall survival. Median overall survival was 16.8 months for those patients administered ivonescimab plus chemotherapy vs. 14.0 months for those receiving placebo plus chemotherapy. It was noted at the time of the primary analysis that the median follow-up time for western patients was 9.2 months and less than the median overall survival at the time of the primary analysis, and these patients may continue to be followed for long-term outcomes. In September 2025, an additional analysis was performed, whereby the western patients were followed to increase their time on study (Asian patients were locked at the time of the primary analysis). In this analysis that included longer-term follow-up of western patients (median follow-up time of western patients of 13.7 months), a hazard ratio consistent with the primary analysis was observed with an improved nominal p-value (HR=0.78; 95% CI: 0.62 – 0.98; nominal p=0.0332). Median OS for this analysis remained the same in both arms from the primary analysis. Median OS in western patients receiving ivonescimab was 17.0 months compared to 14.0 months for those receiving placebo (HR=0.84); median OS in North American patients, specifically, had not yet been reached in the ivonescimab arm compared to 14.0 months in the placebo arm (HR=0.70). The hazard ratios for western patients in totality, as well as patients from the North American and European regions individually, improved from the primary OS analysis to the analysis with longer-term follow-up of western patients. Consistent benefit was observed across pre-defined subgroups. As previously disclosed at the prespecified primary data analysis for PFS, ivonescimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement with a hazard ratio of 0.52 (95% CI: 0.41 – 0.66; p<0.00001). PFS was measured by blinded independent central radiology review committee (BICR) compared to placebo in combination with chemotherapy. Median PFS for ivonescimab vs. placebo plus chemotherapy was 6.8 months vs. 4.4 months, respectively. The PFS analysis was event driven and was conducted with 345 patients enrolled. There was a consistent observed benefit across pre-defined subgroups. In a longer-term follow-up of PFS, which included all western patients and at least six months of follow-up time for all patients, ivonescimab plus chemotherapy demonstrated a consistent, clinically meaningful improvement in PFS with an observed HR of 0.57 (95% CI: 0.46 – 0.71). With the longer-term follow-up analysis, a consistent benefit in western vs. Asian patients was observed, as well as in patients with tumors with either PD-L1 positive or negative expression. This longer-term follow-up analysis of PFS was performed at the time of the primary OS analysis. Overall response rates were higher in the ivonescimab arm (45%) vs. the placebo arm (34%); median duration of response was longer in those patients administered ivonescimab plus chemotherapy (7.6 months) compared to those receiving placebo and chemotherapy (4.2 months) Ivonescimab demonstrated a favorable safety and tolerability profile with no new safety signals identified. The safety results from the HARMONi study were consistent with those observed in the HARMONi-A trial. Ivonescimab has shown positive results in the HARMONi-2 trial, a randomized, double-blind, head-to-head Phase III study against pembrolizumab monotherapy, which led to its approval for first-line treatment of PD-L1-positive NSCLC (its second approved indication). Besides that, 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.

Indice di copertura degli interessi	n/a
Contanti	CN¥9.18b
Patrimonio netto	CN¥8.95b
Totale passività	CN¥7.05b
Totale attività	CN¥16.00b

Dati	Ultimo aggiornamento (ora UTC)
Analisi dell'azienda	2026/08/24 11:39
Prezzo dell'azione a fine giornata	2026/08/20 00:00
Utili	2025/12/31
Utili annuali	2025/12/31

Pacchetto	Dati	Tempistica	Esempio Fonte USA ^*
Dati finanziari della società	10 anni	Conto economico Rendiconto finanziario Bilancio	Modulo SEC 10-K Modulo SEC 10-Q
Stime di consenso degli analisti	+3 anni	Previsioni finanziarie Obiettivi di prezzo degli analisti	Rapporti di ricerca degli analisti Blue Matrix
Prezzi di mercato	30 anni	Prezzi delle azioni Dividendi, scissioni e azioni	Dati di mercato ICE Modulo SEC S-1
Proprietà	10 anni	Top azionisti Insider trading	Modulo 4 SEC Modulo 13D SEC
Gestione	10 anni	Team di leadership Consiglio di amministrazione	Modulo SEC 10-K Modulo SEC DEF 14A
Sviluppi principali	10 anni	Annunci aziendali	Modulo 8-K SEC

Analista	Istituzione
Rebecca Liang	Bernstein
Ethan Cui	BofA Global Research
Zhishun Siu	CCB International Securities Limited

Akeso Salute del bilancio

Criteri Salute finanziaria verificati 4/6

Informazioni chiave

Aggiornamenti recenti sulla salute finanziaria

Recent updates

Akeso Receives Clinical Trial Clearance For AK157D1 B7-H3 Antibody-Drug Conjugate In Solid Tumors

Akeso, Inc. to Report First Half, 2026 Results on Aug 27, 2026

Akeso Announces Approval Of Ivonescimab Injection In Combination With Chemotherapy For First-Line Treatment Of Advanced Squamous Non-Small Cell Lung Cancer

Akeso Doses First Patient in Phase Ii Study of Trop2/Nectin-4 Bispecific Adc (Ak146d1) Combined with Ivonescimab in Breast Cancer

Akeso Announces First Patient Dosed In Phase Ib/II Study Of HER3 ADC AK138D1 Combined With Ivonescimab In Lung Cancer

Akeso Enters Collaboration with Memorial Sloan Kettering Cancer Center to Advance Phase Ii Clinical Study of Cadonilimab-Based Combination Regimen for Perioperative Treatment of Locally Advanced Resectable Her2-Negative Gastric or Gastroesophageal Junction Adenocarcinoma

Akeso Presents Phase Ii Results for Ligufalimab-Based Combination in Frontline Acute Myeloid Leukemia

Akeso Enrolls First Patient in Phase Ib/Ii Clinical Study of Next-Generation Her3 Antibody-Drug Conjugate Ak138d1 for Advanced Breast Cancer

Akeso Announces Approval of Gumokimab (Ak111) for Moderate-To-Severe Plaque Psoriasis by NMPA

Akeso, Inc., Annual General Meeting, Jun 29, 2026

Akeso Announces Ivonescimab Plus Chemotherapy Demonstrates Significant Overall Survival Benefit in First-Line Sq-Nsclc in Harmoni-6 Phase Iii Study

Akeso Inc Announces Phase II Data of Ligufalimab Combination Therapy in Frontline Acute Myeloid Leukemia

Akeso, Inc. Secures Multiple Authoritative Updates And Upgrades For Ivonescimab In The 2026 CSCO NSCLC Guideline

Akeso, Inc. Presents Positive Phase II Results For Cadonilimab Combination In Advanced Pancreatic Cancer

Akeso Presents Updated Data on Cadonilimab Combination Therapy in PD-(L)1 Inhibitor-Resistant Advanced NSCLC at ELCC 2026

Akeso, Inc. Announces the Results of Health-Related Quality of Life (HRQoL) Data from the HARMONi-2 Study At the 2026 European Lung Cancer Congress

Akeso Inc Announces Phase II Initiation Of Novel ADCs Combined With Ivonescimab And Cadonilimab

Akeso, Inc. to Report Fiscal Year 2025 Results on Mar 26, 2026

Akeso, Inc. Presents Long-Term Phase II Results For Cadonilimab In Recurrent Or Metastatic Cervical Cancer

Akeso, Inc.'s IL-4Ra/ST2 Bispecific Antibody Cleared for Seven Phase II Studies in China Spanning Respiratory and Autoimmune Indications

Akeso, Inc. Receives Fifth Breakthrough Therapy Designation from NMPA for Ivonescimab in First-Line Treatment of Advanced Biliary Tract Cancer

Akeso, Inc. Announces NMPA Acceptance of Second NDA for Gumokimab (IL-17A Inhibitor) in Active Ankylosing Spondylitis

Akeso, Inc. Announces Presentation of Real-World Study At the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium

Akeso, Inc. Announces the National Medical Products Administration Approves Significant Label Update in China for its Internally Develop, PD-1/VEGF Bispecific Antibody, ivonescimab

Cadonilimab (PD-1/CTLA-4) Receives FDA Clearance for Global Phase III First-Line Gastric Cancer Trial Versus Nivolumab

Akeso, Inc. Announces Updated Efficacy Data of Ivonescimab Combined with Chemotherapy as First-Line Treatment for TNBC Presented atESMO IO 2025

Akeso, Inc. Announces Phase II Data of Cadonilimab Regimen as Neoadjuvant Therapy for Resectable Gastric Cancer Presented at ESMO Asia Congress

Akeso, Inc.'s Bispecific Antibody Targeting Aß and BBB-Expressed Receptor Approved for Alzheimer's Disease Clinical Trials in China

Akeso Announces First Patient Dosed in Phase I Trial of Personalized mRNA Vaccine AK154 as Monotherapy or in Combination with Cadonilimab or Ivonescimab for Adjuvant Treatment of Pancreatic Cancer

Akeso, Inc. Unveils Promising Preclinical Data for IL-1RAP Targeting Antibody (Ak135) At SITC 2025

Akeso's Ivonescimab Secures Fourth Breakthrough Therapy Designation in China for First-Line Treatment of Triple-Negative Breast Cancer

Summit Therapeutics Inc. Announces Results from the Phase III Harmoni-A Trial, Conducted in China and Sponsored by Akeso, Inc

Akeso Announces Results of the Registrational Phase III Clinical Study Evaluating Ivonescimab (PD-1/VEGF Bispecific Antibody)

HARMONi-6 Phase III Study of Ivonescimab Accepted by the Lancet and Selected for ESM0 2025 LBA Presentation

Akeso Inc. Announces Late-Breaking abstract (LBA) from the Registrational Phase III Clinical Study (AK-306/HARMONi-6 Study) of Ivonescimab

Akeso, Inc. Announces First Patient Dosed in Registrational Phase II Study of TIGIT/TGF-b Bifunctional Antibody Fusion Protein AK130 Combined with Ivonescimab for Advanced Pancreatic Cancer

Akeso, Inc. Announces First Patient Dose in Global Registrational Trial of Cadonilimab (PD-1/CTLA-4) for PD-1 Treatment-Resistant Hepatocellular Carcinoma

Akeso Inc. Announces Data from a Phase Ib/II Clinical Study Evaluating the Combination of Cadonilimab and Pulocimab (VEGFR-2) in Patients with Immunotherapy (IO-Resistant NSCLC)

Akeso, Inc. Announces HARMONi-A Study Conducted in China Reaches OS Clinical Endpoint

Akeso, Inc. has completed a Follow-on Equity Offering in the amount of HKD 3.521667 billion.

Akeso Announces Completion of Patient Enrollment in Phase III Clinical Trial for Ivonescimab as First-Line Treatment for Biliary Tract Cancer Compared to PD-L1 Therapy

Akeso, Inc. has filed a Follow-on Equity Offering in the amount of HKD 3.970287 billion.

Akeso Inc. Reports Phase 3 Trials Show Positive Results: Gumokimab (IL-17) for Ankylosing Spondylitis and Manfidokimab (IL-4Ra) for Atopic Dermatitis Achieve Primary Endpoints

Akeso, Inc. Announces First Patient Dosed in Pivotal Phase Iii Trial of Cadonilimab (Pd-1/Ctla-4) for Perioperative Treatment of Resectable Gastric Cancer

Akeso, Inc. to Report First Half, 2025 Results on Aug 26, 2025

Akeso, Inc. Announces First Patient Dosed in Phase III Trial of Ivonescimab as Consolidation Therapy for Limited-Stage SCLC After Definitive Radiotherapy

Akeso, Inc. Announces Approval to Initiate Global Registrational Trial of Cadonilimab (PD-1/CTLA-4) for PD-1 Treatment-Resistant Hepatocellular Carcinoma

Akeso, Inc. Announces Completion of First Dosing in Phase III Clinical Trial of Ivonescimab (PD-1/VEGF) Combination Therapy for Immunotherapy-Resistant NSCLC

National Medical Products Administration Accepts sNDA for Ivonescimab in Combination with Chemotherapy as First-Line Treatment for Advanced Squamous Non-Small Cell Lung Cancer

Akeso, Inc. Announces First Patient Enrollment in Phase III Trial of Ivonescimab for Pancreatic Cancer

Akeso, Inc. Announces First Patient Enrolled in the Phase III Trial (AK112-312/HARMONi-GI6) of Ivonescimab for First-Line Treatment of Advanced Metastatic Colorectal Cancer

Akeso's First Bispecific Adc (Trop2/Nectin4 Adc) Enters Clinical Trials, Strengthening Leadership in 'Io+Adc'2.0 Strategy

Akeso, Inc. Presents Subgroup Analysis Data from the Phase III Company-16 Trial

Akeso, Inc., Annual General Meeting, Jun 30, 2025

Akeso's PD-1/CTLA-4 Bispecific Antibody Cadonilimab Approved for First-Line Treatment of Cervical Cancer in All-Comer Populations

Akeso, Inc. Announces Its Globally First-In-Class PD-1/VEGF Bispecific Antibody, Ivonescimab, Received Approval from the National Medical Products Administration

Akeso, Inc. Announces FDA Approval for Penpulimab-kcqx in Two BLA Indications for Comprehensive Treatment of Advanced Nasopharyngeal Carcinoma

Summit Therapeutics Inc. Announces Phase Iii Clinical Trial, Harmoni-6

Akeso's Ebdarokimab Receives Marketing Approval from the National Medical Products Administration

Akeso, Inc. to Report Fiscal Year 2024 Results on Mar 30, 2025

Akeso's Penpulimab Receives NMPA Approval for First-Line Treatment of Nasopharyngeal Cancer

Akeso, Inc. Announces the Publication of Its Phase III Clinical Trial Results for Ivonescimab in Head-to-Head Comparison with Pembrolizumab in The Lancet

Akeso Announces Completion of Patient Enrollment in the Phase III Clinical Trial of Cadonilimab for Adjuvant Treatment of High-Risk Recurrent Hepatocellular Carcinoma

Akeso, Inc. Announces First ADC Drug Clinical Trial, Marking a New Era for "IO 2.0 + ADC" Strategy

Akeso, Inc. Enrolles First Patient in The Phase III Clinical Trial of Ivonescimab in Combination with Chemotherapy for First-Line Treatment of Triple-Negative Breast Cancer

Akeso, Inc. Announces IND Acceptance for AK139, a Bispecific Antibody Targeting IL-4Ra and ST2 for Respiratory and Skin Diseases

Akeso, Inc. Announces Enrollment of First Patient in Phase 3 Trial of Cadonilimab for Consolidation Therapy After Current or Sequential Chemoradiotherapy in NSCLC

Akeso, Inc. Announces the Completion of Patient Enrollment in the Phase III Clinical Trial (HARMONi-6) Comparing Ivonescimab

Akeso, Inc.'s Gumokimab Monoclonal Antibody (IL-17) New Drug Application for the Treatment of Moderate to Severe Psoriasis Accept by NMPA

Akeso, Inc. Publishes Results for Cadonilimab (PD-1/CTLA-4) Phase III Data for First Line Treatment of Advanced Gastric Cancer

Akeso Announces the Inclusion in China's National Reimbursement Drug List of Cadonilimab and Ivonescimab

Akeso, Inc.'s Penpulimab Combination Therapy for First-Line Treatment of Hepatocellular Carcinoma Accepted by NMPA

Akeso, Inc. Publishes Mechanism of Action for CLDN18.2/CD47 Bispecific Antibody AK132 for the First Time at SITC Annual Meeting

Akeso Announces First Patient Enrollment in Phase 3 Trial of Ivonescimab Combined with Ligufalimab (CD47) for First-Line Treatment of Head and Neck Squamous Cell Carcinoma (HNSCC), Compared to Pembrolizumab

Akeso, Inc. has completed a Follow-on Equity Offering in the amount of HKD 1.942576 billion.