Akeso's Ivonescimab to Enter Combination Clinical Trials with Multiple Pfizer ADCs for Solid Tumors

Yida Fang^®（Ivonescimab InjectionIt is a globally pioneering PD-1/VEGF bispecific immunotherapy drug for cancer, independently developed by Akeso.Yida Fang^®In May 2024, it received approval from the China National Medical Products Administration (NMPA) for marketing and is indicated for locally advanced or metastatic nsq-NSCLC with disease progression after EGFR-TKI treatment. This makes it the world's first bispecific antibody drug approved based on a "tumor immunotherapy + anti-angiogenesis" synergistic mechanism; in November of the same year,Yida Fang^®And the indicationIncluded in the 2024 National Medical Insurance Catalog.

Currently,Yida Fang^®A Phase III Study Comparing Monotherapy to Pembrolizumab Monotherapy as First-Line Treatment for PD-L1 Positive Advanced NSCLC Met the Primary Endpoint of Progression-Free Survival at the Interim Analysis, Yielding a Decisive Positive Outcome. Based on this study,Yida Fang^®Monotherapy as first-line treatment for PD-L1 positive advanced NSCLC has been submitted for sNDA and granted priority review. Meanwhile,Yida Fang^®A Phase III Clinical Study Comparing Combination Chemotherapy with Tislelizumab Plus Chemotherapy as First-Line Treatment for sq-NSCLC, Led by Partner Summit TherapeuticsYida Fang^®International Multicenter Phase III Clinical Study (HARMONi Study) of Combination Chemotherapy for EGFR-Mutated, Locally Advanced or Metastatic nsq-NSCLC Progressed After Third-Generation EGFR-TKI TreatmentYida Fang^®International Multicenter Phase III Study of Combined Chemotherapy Versus Pembrolizumab Combined with Chemotherapy as First-Line Treatment for sq-NSCLC（HARMONi-3Research)AndYida Fang^®Monotherapy vs. Pembrolizumab as First-Line Treatment for PD-L1 High-Expressing Advanced NSCLC: An International Multicenter StudyClinical Research（HARMONi-7Research）In progress.

In addition, Akeso has newly launched four Phase III clinical trials, including the first-line treatment of PD-L1 positive head and neck squamous cell carcinoma with Ivonescimab combined with AK117 (CD47) (vs. Pembrolizumab), the first-line treatment of biliary tract cancer with Ivonescimab combination therapy (vs. Durvalumab combination therapy), and the first-line treatment of pancreatic cancer with Ivonescimab combination therapy.AndAkesoCombined Regimen as First-Line Treatment for Triple-Negative Breast Cancer. Overall,Yida Fang^®Currently, 26+ clinical trials are being conducted across 17 indications, including non-small cell lung cancer, squamous cell carcinoma of the head and neck, biliary tract cancer, pancreatic cancer, breast cancer, hepatocellular carcinoma, and colorectal cancer, through monotherapy and combination therapy, with nearly 10 in Phase III clinical trials.

In February 2025, Summit Therapeutics, the international market partner of Akeso's Ivonescimab, reached a clinical trial collaboration with Pfizer to jointly advance the combination therapy of Ivonescimab and multiple Pfizer antibody-drug conjugates (ADCs) for the treatment of various solid tumors.

Akeso (9926.HK) is a leading company that integrates the research, development, production, and commercialization of globally pioneering or best-in-class innovative biologics. Since its establishment in 2012, the company has built its unique end-to-end Akeso Comprehensive New Drug R&D Platform (ACE Platform), and developed an innovative R&D system centered on Tetrabody bispecific antibody technology, Antibody-Drug Conjugate (ADC) technology, mRNA technology, and cell therapy technology. It also established a GMP production system meeting international standards and an advanced commercial operation model, positioning itself as a competitive biopharmaceutical innovator on a global scale.

The company has developed more than 50 innovative drug candidates for the treatment of major diseases such as cancer, autoimmune disorders, inflammation, and metabolic conditions. Among these, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific ADCs), six new drugs are already in commercial sales, and five new drugs...Indications forThe marketing application is currently under review and approval., Two globally first-in-class innovative drugs included in the national medical insurance catalog.

In August 2021, Akeso's independently developed differentiated PD-1 monoclonal antibody, AniKe^®Approved for marketing; In June 2022, Akeso's world-first PD-1/CTLA-4 bispecific antibody, Cadonilimab.^®Approved for marketing, becoming the world's first approved bispecific antibody for cancer immunotherapy and China's first bispecific antibody new drug.2024First Half of the Year，Akeso^®The supplemental New Drug Application (sNDA) for first-line treatment of advanced cervical cancer has been accepted.Kantanini^®The combination regimen for first-line treatment of advanced gastric cancer was approved for marketing in September of the same year.2024Year May，CompanyAnother Global First-in-Class Bispecific Antibody DrugYida Fang^®Approved for marketing by the China National Medical Products Administration,For EGFR-TKI Treatment Progressionwith locally advanced or metastatic nsq-NSCLC,Yida Fang^®Becomes the world's first approved bispecific antibody new drug with "tumor immunotherapy + anti-angiogenesis" mechanismDuring the same period, AK112 (Ivonescimab) achieved significant positive results compared to Pembrolizumab in first-line treatment of PD-L1 positive NSCLC. The sNDA for the same indication was accepted by the CDE and granted priority review. Ivonescimab has become the world's only drug to date that demonstrated significantly superior efficacy in a head-to-head Phase III clinical trial against "blockbuster drug" Pembrolizumab, and is expected to become the new standard treatment for first-line lung cancer treatment, providing patients with a brand-new and better "chemotherapy-free" option. Previously,In December 2022, the company granted an external license.Yida Fang^®Partial overseas rights, and with a collaboration plan of $5 billion plus sales royalties, set the record for the highest transaction amount for a single drug out-licensing deal in China at that time.September 2024,Independently developed by the companyYixining^®(Inclisiran, PCSK9) Approved for Two Indications in the Treatment of Hypercholesterolemia, Becoming the First Non-Oncology Product to Gain Approval.Currently,Kantanini^®、Yida Fang^®Have all been included in the 2024 National Medical Insurance Drug List.

Akeso expects to become a world-leading biopharmaceutical company by developing innovative drugs with international first-in-class and best-in-class therapies through efficient and groundbreaking R&D innovation.