HONG KONG,Nov. 28,2024 -- Akeso,Inc. (9926. HK) ("Akeso" or the "Company") is pleased to announce that two of its independently developed,globally pioneering bispecific antibody drugs—cadonilimab Injection (PD-1/CTLA-4 bispecific antibody) and ivonescimab Injection (PD-1/VEGF bispecific antibody)—have both been included in the most recent National Reimbursement Drug List (NRDL) released by China's National Healthcare Security Administration. The most recent NRDL will become effective on January 1,2025.

Cadonilimab is included for the treatment of relapsed or metastatic cervical cancer (R/M CC) patients who progressed on or after platinum-based chemotherapy.

Ivonescimab is included for the treatment of epidermal growth factor receptor (EGFR) mutated locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC).

China's medical insurance system includes basic medical insurance,work-related injury insurance,and maternity insurance,covering over 95% of the population. The NRDL defines the medications eligible for reimbursement under the medical insurance fund. According to statistical reports,in 2023,expenditures from China's basic medical insurance,and maternity insurance funds on drugs listed in the NRDL accounted for 90% of total hospital procurement orders.

Dr. Xia Yu,the Founder,Chairwoman,President,and Chief Executive Officer of Akeso,said," The inclusion of cadonilimab and ivonescimab in the National Reimbursement Drug List emphasizes the innovative and clinical significance of these groundbreaking biologics,both of which are developed by Akeso. The inclusion marks a significant milestone in improving patient access to innovative treatments. It will substantially reduce the financial burden on patients,allowing more individuals to benefit from globally leading therapies. This development aligns perfectly with Akeso's core philosophy of advancing public health through scientific and technological innovation."

Cadonilimab: Global First Approved Cancer Immunotherapy Bispecific Antibody

Cadonilimab is an innovative bispecific antibody that simultaneously targets PD-1 and CTLA-4,leveraging a synergistic antitumor effect. This unique mechanism significantly enhances therapeutic outcomes,offering superior efficacy while greatly reducing toxicity. The latest data on cadonilimab for R/M CC shows that cadonilimab benefits both PD-L1 positive and negative patient populations,especially addressing an unmet need from PD-L1 negative patients,which previously lacked effective treatment options. For R/M CC,cadonilimab demonstrated a median overall survival (mOS) of over 18 months (NR),with an objective response rate (ORR) of 31.3% and a complete response (CR) rate of 13.1% in In the PD-L1 positive subgroup,the ORR reached 43.8%,with a median progression-free survival (mPFS) of 6.34 months,and the mOS is yet to be reached.

On September 2024,cadonilimab was approved by NMPA for first-line treatment of advanced gastric cancer. The sNDA for first-line treatment of advanced cervical cancer is under review. Cadonilimab has been strongly recommended in 16 clinical treatment guidelines and consensus statements,covering a variety of cancers,including gastric cancer,gynecological cancers,liver cancer,esophageal cancer,and nasopharyngeal cancer. Furthermore,cadonilimab is currently undergoing more than 23 clinical trials across 16 indications,including gastric,lung,liver,cervical,and pancreatic cancers. Among these trials,8 are registration Phase III trials.

Ivonescimab: Global First Approved PD-1/VEGF Bispecific Antibody

Ivonescimab is the world's first bispecific antibody that integrates "cancer immunotherapy and anti-angiogenesis" into a synergistic mechanism. In the Phase III HARMONi-A trial,for 2L+ EGFRm NSCL,ivonescimab combination therapy reduced the risk of disease progression or death by a record 54%,with a significant trend towards long-term survival benefits. Additionally,the Phase III HARMONi-2 trial comparing ivonescimab monotherapy with pembrolizumab in first-line treatment of PD-L1-positive non-small cell lung cancer (NSCLC) showed ivonescimab's superiority. Ivonescimab is the only drug globally to have demonstrated significantly better efficacy than pembrolizumab in a Phase III head-to-head trial.

The sNDA for Ivonescimab in the first-line treatment of PD-L1-positive NSCLC is currently under regulatory review,with priority review status granted. Ivonescimab has already been robustly recommended within six major clinical treatment guidelines and consensus statements.

Additionally,ivonescimab has been engaged in over 25 clinical trials spanning more than 17 varieties of cancers,namely lung cancer,head and neck squamous cell carcinoma,biliary tract cancer,pancreatic cancer,breast cancer,hepatocellular carcinoma,and colorectal cancer. Nearly 10 Phase III trials of ivonescimab are progressing efficiently in China and the rest of the World,with one of them being on head and neck squamous cell carcinoma.

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,22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally,5 new drugs are commercially available,and 5 new drugs across 7 indications are currently under regulatory review for approval. 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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