Akeso Announces the Completion of Patient Enrollment in the Phase III Clinical Trial (HARMONi-6) Comparing Ivonescimab and Tislelizumab for First-Line Treatment of Sq-NSCLC

HONG KONG,Feb. 6,2025 --Akeso,Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce the completion of patient enrollment in the global Phase III clinical trial (HARMONi-6/AK112-306) evaluating ivonescimab,its independently developed PD-1/VEGF bispecific antibody. This clinical study,conducted in China,compares ivonescimab in combination with platinum-based chemotherapy to tislelizumab (a PD-1 inhibitor) combined with platinum-based chemotherapy as a first-line treatment for squamous non-small cell lung cancer (sq-NSCLC).

In addition,several international Phase III clinical trials of ivonescimab are underway. These clinical studies include the HARMONi-3 clinical trial,which compares ivonescimab plus chemotherapy to pembrolizumab plus chemotherapy for the first-line treatment of both sq-NSCLC and non-squamous NSCLC (nsq-NSCLC). This trial is being efficiently led by Summit Therapeutics,Akeso's global partner for ivonescimab.

The HARMONi-6/AK112-306 trial is one of six registrational/Phase III studies worldwide for ivonescimab for lung cancer. It is also one of six studies where PD-1/L1 inhibitors are used as comparators. This initiative is a critical step in advancing cancer immunotherapy,establishing superior global treatment standards,and exploring the full clinical and commercial potential of ivonescimab within Akeso's portfolio.

Ivonescimab,in combination with chemotherapy,has already been approved in China for the treatment of EGFR-TKI-resistant,non-squamous NSCLC. The New Drug Application (sNDA) for ivonescimab monotherapy as a first-line treatment for PD-L1-positive NSCLC (in comparison to pembrolizumab) is currently under review and has been granted priority status in China.

As a next-generation,highly efficacious cancer immunotherapy,ivonescimab is also in multiple Phase III studies beyond lung cancer. These studies include ongoing Phase III trials for PD-L1-positive head and neck squamous carcinoma (vs. pembrolizumab),first-line treatment of biliary tract cancer (with chemotherapy vs. durvalumab + chemotherapy),and the first-line treatment of pancreatic cancer. Clinical trials of ivonescimab for the first-line treatment of triple-negative breast cancer,colorectal cancer,hepatocellular carcinoma,ovarian cancer and gastric cancer,are also in progress.

As these studies progress,ivonescimab has the potential to redefine the standard of care in immuno-oncology around the world,with its clinical and commercial potential realized on a global scale.

Data indicates that the annual incidence of advanced,driver gene-negative sq-NSCLC exceeds 520,000 cases,with many patients ineligible for anti-angiogenesis treatments like bevacizumab. While PD-1/L1 inhibitors combined with chemotherapy have become the global standard of care,including in the U.S. and China,the prognosis for these patients remains poor,highlighting a critical unmet need. Phase III studies show that ivonescimab,targeting both PD-1 and VEGF,offers a synergistic anti-tumor effect with a favorable safety profile. This makes ivonescimab a promising alternative for sq-NSCLC patients who cannot receive bevacizumab due to bleeding risks. Ivonescimab is poised to transform first-line treatment for locally advanced or metastatic sq-NSCLC,providing a safer and more effective immunotherapy option that exceeds current treatment standards.