AKESO(HK:09926) Zheng Quan Shi Bao Wang·2026-01-13 01:45Core Viewpoint - Kangfang Biopharma's innovative PD-1/VEGF dual antibody, Ivosidenib, has submitted a Biologics License Application (BLA) to the FDA for treating EGFR mutation non-squamous non-small cell lung cancer (NSCLC) [1] Group 1: Company Developments - Ivosidenib's BLA submission is based on the overall results of the global Phase III HARMONi trial [1] - The application was submitted by Summit Therapeutics, the overseas partner of Kangfang Biopharma [1] Group 2: Regulatory Timeline - The FDA is expected to make a review decision on the BLA by the fourth quarter of 2026 [1] - The BLA aims to support the use of Ivosidenib in combination with chemotherapy for patients with EGFR mutation NSCLC who have progressed after third-generation EGFR-TKI treatment [1]