宜明昂科-B(01541.HK):IMM01(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

Core Viewpoint - The company Yiming Pharmaceutical-B (01541.HK) has received approval from the National Medical Products Administration for clinical trials of IMM01 (Tida-pasip), aimed at treating atherosclerosis [1] Group 1: Product Information - The core product IMM01 (Tida-pasip) is an innovative targeted CD47 molecule and is the first SIRPα-Fc fusion protein to enter clinical stages in China [1] - IMM01 (Tida-pasip) utilizes a dual mechanism to activate macrophages by blocking the "don't eat me" signal through interference with the CD47/SIRPα interaction and delivering the "eat me" signal via Fc-gamma (Fcγ) receptor activation [1] - The CD47 binding domain of IMM01 (Tida-pasip) has been specially modified to avoid binding with human red blood cells (RBCs), demonstrating good safety and macrophage activation capabilities [1] Group 2: Regulatory Approvals - The combination of IMM01 (Tida-pasip) with Azacitidine for frontline treatment of Chronic Myelomonocytic Leukemia (CMML) received orphan drug designation from the U.S. Food and Drug Administration (FDA) in November 2023 [1]

IMMUNEONCO-宜明昂科-B(01541.HK):IMM01(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 - Reportify