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Microchip's partner submits Chidamide's listing application in Japan and is accepted

 Last Update: 2021-07-07
 Source: Internet
 Author: User

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On April 28, Microchip released an announcement stating that its partner Huya Bio-International Co.
, Ltd.
(a U.
S.
company, “Huya” for short) has recently requested the Japan Pharmaceuticals and Medical Devices Agency (PMDA) on Chidamide (overseas).
Number: HBI-8000) Single-drug treatment of relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) has submitted a new drug marketing application (NDA) and was accepted
.

This is after the submission of a listing application for the first indication of Chidamide in Japan on September 30, 2020, and another submission of a listing application for the second indication of Chidamide

Chidamide is the world's first subtype-selective histone deacetylase (HDAC) inhibitor and the world's first oral administration approved for the treatment of peripheral T-cell lymphoma and combined with endocrine drugs for the treatment of estrogen receptor-positive breast cancer patients The drug, targeting class I histone deacetylase (HDAC), induces cell cycle arrest, inhibits the expression of a variety of oncogenes, regulates the acetylation of PD-L1, and enhances the activity of immune checkpoint inhibitors.
Epigenetic regulator drugs
.

In preclinical animal models, it can also have an immunomodulatory effect by increasing the efficacy of checkpoint inhibitors

Peripheral T-cell lymphoma (PTCL) is a group of highly heterogeneous abnormal malignant proliferation of lymphocytes.
It belongs to non-Hodgkin's lymphoma, including mature T-cell and NK-cell tumors derived from the thymus
.

The incidence of peripheral T-cell lymphoma has obvious regional differences.

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