SHANGHAI, China – July 16, 2026 – ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (“ImmuneOnco”, HKEX: 01541.HK) announced today that the pivotal Phase III registrational clinical trial of its core product, timdarpacept (IMM01), for the treatment of chronic myelomonocytic leukemia (CMML), has successfully completed the full enrollment of all 173 patients.

This Phase III trial is designed to evaluate the efficacy and safety of timdarpacept in combination with azacitidine compared to placebo plus azacitidine in treatment-naïve CMML patients. Previously, the study met its pre-specified interim analysis enrollment target of 132 patients ahead of schedule in March 2026 (with an actual enrollment of 133 patients), and completed the full enrollment of 173 patients in June 2026. Finishing enrollment two months ahead of the original timeline underscores the high execution efficiency of the clinical development program.

The Company will maintain close communication with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and advance the registration process in strict compliance with relevant regulatory requirements. Currently, timdarpacept (IMM01) has been granted invention patents in China, the United States, Japan, and the European Union, and has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of CMML.

Dr. Wenzi Tian, Chairman, Chief Executive Officer, and Chief Scientific Officer of ImmuneOnco, commented:

“The completion of full enrollment of 173 patients marks another critical milestone in the commercialization journey of timdarpacept (IMM01). Early-stage clinical data have previously demonstrated that the timdarpacept combination regimen not only yields significantly superior efficacy compared to historical controls but also exhibits a favorable safety profile. We look forward to the upcoming interim analysis data, which we expect will further validate the breakthrough efficacy of timdarpacept. As the Phase III study progresses steadily, this product has the potential to become the world’s first approved CD47-targeted therapy, addressing the unmet need for first-line targeted treatment in CMML and providing a new therapeutic option for patients worldwide.”

Dr. Zhuli Wu, Chief Medical Officer of ImmuneOnco, commented:

“The unique dual mechanism of action of timdarpacept (IMM01) enables potent tumor cell clearance while maintaining an excellent safety profile, which is critical for CMML patients requiring long-term therapy. With the successful completion of the 173-patient enrollment target, our cross-functional clinical team will collaborate closely to advance patient follow-up as planned. We are committed to ensuring high-quality data collection and analysis, with the goal of bringing a highly effective and safe treatment option to CMML patients as soon as possible.”