Akeso (9926.HK) is delighted to announce that the supplemental biologics license application (sBLA) for its independently developed, world's first-in-class PD-1/VEGF bispecific antibody drug, 依达方^® (generic name: ivonescimab Injection), as a monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC), has been accepted by the China National Medical Products Administration (NMPA).

Ivonescimab is the world's first bispecific antibody drug approved for the "tumor immunotherapy + anti-angiogenesis" mechanism. The first-line monotherapy treatment of PD-L1 positive (PD-L1 TPS ≥1%) locally advanced or metastatic NSCLC is ivonescimab's second indication, following its approval for the treatment of EGFR-mutant non-squamous NSCLC that has progressed after EGFR-TKI therapy. Ivonescimab is also expected to become a new standard of care treatment option for both first-line and second-line lung cancer therapy.

This new indication application for ivonescimab is based on the HARMONi-2 (AK112-303) study. The Independent Data Monitoring Committee (IDMC) conducted a pre-specified interim analysis of the HARMONi-2 study, showing highly positive results. In the intent-to-treat (ITT) population, ivonescimab monotherapy significantly prolonged progression-free survival (PFS) compared to pembrolizumab monotherapy, with a hazard ratio (HR) significantly better than expected.

"As a researcher and clinician, we eagerly anticipate ivonescimab becoming the new standard treatment for first-line lung cancer, providing a superior 'chemotherapy-free' option for patients," said Professor Zhou Caicun, principal investigator of the HARMONi-2 study and director of the Oncology Department at East Hospital Affiliated To Tongji University. "The success of the HARMONi-2 study underscores the immense value of ivonescimab's synergistic dual anti-tumor mechanism of 'tumor immunotherapy + anti-angiogenesis.'"

Professor Zhou also emphasized that clinicians are looking forward to Akeso seizing the opportunity to establish ivonescimab as the new standard treatment for first-line lung cancer. He encouraged continuous exploration of combination therapies and ongoing global upgrades to standard treatment options, aiming to provide patients with better therapeutic choices.

Dr. Michelle Xia, Founder, Chairwoman, President, and CEO of Akeso, said: "We are thrilled that ivonescimab has achieved a significant milestone in first-line lung cancer therapy shortly after its approval for second-line treatment. We sincerely thank all our colleagues at Akeso for their decade-long dedication and craftsmanship, the experts for their meticulous contributions, and all the participants involved in the projects."

According to Dr. Xia, the approval of ivonescimab for second-line lung cancer therapy and its potential as a superior, chemotherapy-free new standard for first-line treatment fills a clinical unmet need in global lung cancer immunotherapy with bispecific antibodies, providing a more effective solution for patients and fulfilling Akeso's commitment.

Dr. Xia also emphasized that the HARMONi-2 study showcases ivonescimab's superior efficacy and safety, further solidifying its potential as a cornerstone product in tumor immunotherapy (IO). This includes its broad clinical development value and market prospects when used in combination with ADC drugs or other novel anti-cancer drugs. "We look forward to sharing ivonescimab's robust clinical research data with global regulatory agencies to achieve worldwide approval and provide more effective solutions for patients around the globe."