Shanghai, China, January 12, 2026 – ImmuneOnco Biopharmaceuticals (Shanghai) Inc. ("ImmuneOnco", HKEX stock code: 01541.HK) announced that the clinical trial application for its self-developed timdarpacept (IMM01) targeting atherosclerosis has been officially approved by the National Medical Products Administration (NMPA). 

timdarpacept (IMM01) Targets Atherosclerosis: Core Pathological Basis for Cardiovascular Events with Huge Unmet Medical Need Atherosclerosis is the core pathological basis for major cardiovascular and cerebrovascular events including myocardial infarction and stroke. Despite the widespread application of statins and other existing drugs, a large number of patients still face residual risk, representing a significant unmet medical need. IMM01 is an innovative CD47-targeted drug that can effectively treat atherosclerosis by blocking the CD47/SIRPα signaling pathway to induce macrophage phagocytosis of atherosclerotic plaques. Previously, IMM01 has demonstrated favorable safety and tolerability in clinical trials for other indications. This clinical approval represents the first major attempt in China to expand CD47-targeted drugs into non-oncology fields, and is expected to provide a novel immunomodulatory strategy for atherosclerosis treatment.

In animal experiments, IMM01 has demonstrated tremendous potential in treating atherosclerosis. Particularly in the hCD47/hSIRPα apoE-/- mouse vulnerable plaque model, compared with vehicle control (model group), treatment with IMM01 (5mg/kg, 10mg/kg) or control drug (10 mg/kg) significantly reduced intra-plaque hemorrhage while increasing collagen area, stabilizing plaques and effectively reducing their bleeding risk. Notably, IMM01 showed superior efficacy compared to the control drug in these experiments, further highlighting the unique advantages and broad prospects of IMM01 as a CD47-targeted drug in atherosclerosis treatment. 

Dr. Wenzhi Tian, Founder, Chairman, CEO and CSO of ImmuneOnco, stated: "We are very pleased that IMM01 has obtained clinical approval in atherosclerosis, a major chronic disease field. This is an important strategic initiative based on the scientific mechanism of the CD47 target and our preclinical research data, reflecting our confidence in the therapeutic potential of this target beyond oncology. We will advance clinical trials promptly to explore the safety and efficacy of IMM01 in cardiovascular and metabolic diseases, bringing new treatment hope to hundreds of millions of patients worldwide."