Core Viewpoint - The company has received approval from the National Medical Products Administration of China for clinical trials of IMM01 (Tida-pacisib) for the treatment of atherosclerosis, marking a significant milestone in its product development [1] Group 1: Product Development - IMM01 (Tida-pacisib) is an innovative targeted CD47 molecule and the first SIRPα-Fc fusion protein to enter clinical stages in China [1] - The product utilizes a dual mechanism to activate macrophages by blocking the "don't eat me" signal and delivering the "eat me" signal through Fc-gamma receptors [1] - The CD47 binding domain of IMM01 has been specially modified to avoid binding with human red blood cells, enhancing its safety profile [1] Group 2: Regulatory Approvals - IMM01 (Tida-pacisib) has been granted orphan drug designation by the U.S. Food and Drug Administration for first-line treatment of Chronic Myelomonocytic Leukemia (CMML) in November 2023 [1] Group 3: Intellectual Property - The company holds global intellectual property and commercialization rights for IMM01 (Tida-pacisib), with a patent family that includes granted patents in China, the United States, Japan, and the European Union [2]
宜明昂科-B(01541)：MM01(替达派西普)获国家药监局批准进行动脉粥样硬化治疗的临床试验