IMMUNEONCO-B (01541) announced that the group has received approval from the China National Medical Products Administration (NMPA) to conduct a clinical trial for IMM01 (Tidapaxic) for the treatment of atherosclerosis. The group's core product, IMM01 (Tidapaxic), is an innovative molecule targeting CD47. This product is the first SIRPα-Fc fusion protein to enter the clinical stage in China. IMM01 (Tidapaxic), which possesses an immunoglobulin G1 (IgG1) Fc, can fully activate macrophages through a dual mechanism of action—simultaneously blocking the "don't eat me" signal by interfering with the CD47/SIRPα interaction and transmitting an "eat me" signal by activating the macrophage's Fc-gamma (Fcγ) receptor. Furthermore, the CD47 binding domain of IMM01 (Tidapaxic) has been specially engineered to avoid binding with human red blood cells (RBCs). Due to its differentiated molecular design, IMM01 (Tidapaxic) has demonstrated a favorable safety profile and confirmed its ability to activate macrophages. In November 2023, the combination of IMM01 (Tidapaxic) with azacitidine for first-line treatment of CMML received Orphan Drug Designation from the US Food and Drug Administration (FDA). The group holds the global intellectual property rights and commercialization rights for IMM01 (Tidapaxic). As of the date of this announcement, for IMM01 (Tidapaxic), the group possesses one patent family, including granted patents in China, the United States, Japan, and the European Union.
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