The application for clinical trial of MY008211A tablet was officially accepted by the State Food and Drug Administration
Complement factor B (CFB) inhibitor MY008211A tablets applied byCreaterna Biotechnology Development Co., Ltd. have been formally accepted by Drug Evaluation Center of National Medical Products Administration (Acceptance number: CXHL2200084&CXHL2200084).
Complement factor B (CFB) is a trypsin-like serine protease that circulates in the human blood as a potential enzyme. CFB inhibitors inhibit C3 invertase and C5 invertase activities, prevent MAC formation and intravascular hemolysis, and inhibit positive feedback amplification mechanism, prevent extravascular hemolysis and breakthrough hemolysis. The results of studies on CFB inhibitors showed that CFB inhibitors significantly improved hemolysis in PNH patients with no significant improvement in the treatment of C5 monoclonal antibody Eulizumab, and had a good effect on both intravascular and intravascular hemolysis 。
MY008211A is A Class 1 chemical drug independently developed by the company, which is intended to be used for the development of paroxysmal sleep hemoglobinuria (PNH), immunoglobulin A nephropathy (IgA nephropathy) and other clinical indications. The results of in vitro hemolysis test of red blood cells of PNH patients carried out by the company in cooperation with Wuhan Tongji Medical College showed that MY008211A significantly improved the hemolysis of red blood cells in patients.
Currently, there are three CFB inhibitors in clinical stage in the world, which are small molecules, oligonucleotides and antibodies respectively. No domestic company has yet applied for clinical application of complement B factor inhibitors. MY008211A is expected to be the first CFB inhibitor to enter clinical trials in China. In addition, MY008211A developed by the company is a small-molecule compound, which is expected to provide better compliance and more economical treatment means for domestic patients such as PNH, and better solve the clinical needs.
In addition, the Company has a number of complement related drugs under development, which will provide more clinical treatment options for complement related diseases in the future。
 Pamra B , Par C , D J S , et al. Addition of iptacopan, an oral factor B inhibitor, to eculizumab in patients with paroxysmal nocturnal haemoglobinuria and active haemolysis: an open-label, single-arm, phase 2, proof-of-concept trial. Lancet Haematol. 2021 March 22; 8(5): 344-354
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