share_log

宜明昂科-B(01541.HK):IMM01(替达派西普)获国家药监局批准进行III期临床试验方案

Yiming Angko-B (01541.HK): IMM01 (tidapecip) was approved by the State Drug Administration for phase III clinical trial program

Gelonghui Finance ·  Apr 17 06:20

Gelonghui, April 17, 丨 Yiming Angko-B (01541.HK) announced that in April 2024, the Group has obtained approval from the China National Drug Administration for recurrent or refractory (R/R) classic Hodgkin lymphoma (cL), which recurs or progresses after treatment with IMM01 (tidapecip) and tirelizumab in combination treatment with procedural cellular death protein 1 (PD-1) inhibitors.

The Group's core product IMM01 (tidapecip) is an innovative targeting differentiation cluster 47 (CD47) molecule. This product is the first clinical-stage SIRPα-FC fusion protein in China. iMM01 (tidapecip) with immunoglobulin G1 (IgG1) Fc can fully activate macrophages through a dual mechanism of action — while blocking the “don't eat me” signal by interfering with CD47/SIRPα interaction, and transmits the “eat me” signal through Fc-gamma (Fcgamma) receptors that activate macrophages. Furthermore, the CD47 binding domain of IMM01 (tidapecip) has been specially modified to avoid binding to human red blood cells (RBCs). With a differentiated molecular design, IMM01 (tidapecip) showed good safety and confirmed its ability to activate macrophages.

The Group has independent global intellectual property rights and commercialization rights for IMM01 (Tidapacip). As of the date of this announcement, the Group has a family of patents for IMM01 (tidapacip), which includes authorized patents in China, the United States, Japan and the European Union.

Disclaimer: This content is for informational and educational purposes only and does not constitute a recommendation or endorsement of any specific investment or investment strategy. Read more
    Write a comment