Akeso Biopharma’s Ivonescimab NDA Accepted by NMPA, Strengthening NSCLC Treatment Options

Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has received a significant boost with the acceptance of its New Drug Application (NDA) by the National Medical Products Administration (NMPA) for Yidafang (ivonescimab), a pioneering bispecific antibody targeting both programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). This therapy is positioned as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that tests positive for PD-L1 expression (PD-L1 TPS≥1%). Notably, ivonescimab is the world’s first PD-1/VEGF bispecific antibody, previously approved for first-line treatment of non-squamous NSCLC with EGFR mutations in patients who have progressed after EGFR-TKI treatment. The potential approval of this application could establish ivonescimab as a new standard of care for both first- and second-line NSCLC treatments. In a strategic move, Akeso entered into a deal valued at USD 5 billion with Summit Therapeutics Inc. (NASDAQ: SMMT) in December 2022, granting the latter exclusive development and commercialization rights for ivonescimab in the US, Canada, Europe, and Japan, with an additional licensing agreement signed in June 2024 to expand into new markets including Central and South America, the Middle East, and Africa.- Flcube.com