Product Development Progress - The company has completed the recruitment of 104 patients for the Phase III clinical trial of its core product IMM01 (Tidutamab) for first-line treatment of chronic myelomonocytic leukemia (CMML) as of December 31, 2025, with plans to complete the recruitment of 132 patients by the end of March 2026 for mid-term analysis [1] - If the mid-term analysis data meets expectations, the company plans to submit a pre-BLA (pre-Biologics License Application) to regulatory authorities by the end of 2026, which is a critical step towards commercialization [1] - On January 12, 2026, IMM01 received approval from the National Medical Products Administration of China to initiate clinical trials for the treatment of atherosclerosis, with plans to advance this area to Phase Ib/II studies by 2026 [1] Business Progress - The Phase III registration clinical trial for another core product, IMM0306 (CD47xCD20 bispecific antibody), targeting relapsed refractory follicular lymphoma, is set to begin patient recruitment by the end of January 2026 [1] - The company has terminated its licensing agreement with Instil Bio's subsidiary Axion Bio, reclaiming global rights to IMM2510 (PD-L1xVEGF bispecific antibody) and IMM27M (CTLA-4 antibody), while retaining a payment of $35 million [2] - The founder stated that the company is in discussions with multiple multinational pharmaceutical companies to seek new partners for global development in 2026 [2] Company Status - On February 10, 2026, the company provided a loan of 13.7247 million RMB to its founder, indicating a good financial condition that will not affect daily operations [3] Industry Policy Status - The company is focused on tumor immunotherapy and was established in 2015, listing on the Hong Kong Stock Exchange in 2023, with a research pipeline that includes 14 candidate drugs centered around the CD47 target [4]
宜明昂科核心产品IMM01临床进展顺利，计划年底前递交preBLA申请