Chidamide

Chidamide(Product Name:Epidaza®)


Chidamide is a new molecule entity with global patent protection independently developed by Chipscreen Biosciences, the world's first oral subtype-selective histone deacetylase (HDAC) inhibitor, and a Class 1.1 new drug. In December 2014, Chidamide was approved by the NMPA for the treatment of relapsed and refractory peripheral T-cell lymphoma (PTCL), the first indication of the drug. In November 2019, the second indication of Chidamide was approved by the NMPA for combination treatment with aromatase inhibitor in post-menopausal patients with hormone receptor-positive, HER2-negative, recurrent or progressive locally advanced or metastatic breast cancer previously treated with endocrine therapy, indicating the expansion of Chidamide treatment from hematological tumors to solid tumors.


Chidamide is a new molecule entity with global patent protection independently developed by Chipscreen Biosciences, the world's first oral subtype-selective histone deacetylase (HDAC) inhibitor, and a Class 1.1 new drug. In December 2014, Chidamide was approved by the NMPA for the treatment of relapsed and refractory peripheral T-cell lymphoma (PTCL), the first indication of the drug. In November 2019, the second indication of Chidamide was approved by the NMPA for combination treatment with aromatase inhibitor in post-menopausal patients with hormone receptor-positive, HER2-negative, recurrent or progressive locally advanced or metastatic breast cancer previously treated with endocrine therapy, indicating the expansion of Chidamide treatment from hematological tumors to solid tumors. In April 2019, Chidamide received Level I recommendations in the2019 CSCO Diagnostic and Therapeutic Guidelines for Lymphomas. In April 2020, Chidamide received Level I recommendations in the 2020 CSCO Diagnostic and Therapeutic Guidelines for Breast Cancer.


In October 2006, Chipscreen reached an agreement with HUYA Biosciences for worldwide development and commercialization of Chidamide in developed countries such as the United States. Chidamide became the first Chinese innovative drug to be out-licensed to Europe and America, generating licensing revenue. At present, studies involving Chidamide monotherapy and combination therapy with other anti-tumor drugs for other hematological tumors, solid tumors and HIV are being carried out simultaneously in countries and regions such as the United States, Japan, China, and Taiwan.


Chidamide is a subtype selective benzamide inhibitor of HDAC, targeting against subtypes 1, 2, 3 of class I HDAC and subtype 10 in class IIb. It has a regulatory effect on epigenetic abnormalities related to tumorigenesis. Chidamide induces chromatin remodeling by inhibiting relevant HDAC subtypes to increase the acetylation level of chromatin histones, which thereby leads to changes (i.e., epigenetic changes) in gene expression of multiple signal transduction pathways targeted at tumorigenesis. Chidamide directly inhibits the cell cycle and induces apoptosis of tumor cells in the blood and lymphatic system. It can induce and activate the tumor killing effect mediated by natural killer cells (NK) and antigen-specific cytotoxic T-cells (CTL), and has overall regulatory activity on the anti-tumor cellular immunity of the body. Chidamide also induces the differentiation of tumor stem cells and reverses the epithelial mesenchymal phenotype transformation (EMT) of tumor cells through epigenetic regulation mechanisms, thereby playing a potential role in restoring the drug sensitivity of drug-resistant tumor cells, and inhibiting tumor metastasis and recurrence.


Figure. Molecular Antitumor Mechanism of Action of Chidamide (Epidaza)



 



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