India, July 28 -- Biopharmaceutical company Akeso Inc. (AKESF) announced Monday that China's National Medical Products Administration or NMPA has accepted the supplementary New Drug Application or sNDA for ivonescimab (PD-1/VEGF bispecific antibody) in combination with chemotherapy as a first-line treatment for advanced squamous non-small cell lung cancer or sq-NSCLC.
The decision is based on positive outcomes from the Phase III HARMONi-6 study, which demonstrated the superiority of ivonescimab combined with chemotherapy over existing treatments.
The latest approval is the third accepted application for ivonescimab in China. Previous filings were for its combination therapy in EGFR-TKI resistant locally advanced or metastatic non-squamous...