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

On April 28, Microchip released an announcement stating that its partner Huya Biological International Co., Ltd. (a U.S. company, “Huya”) recently requested the Japan Pharmaceuticals and Medical Devices Agency (PMDA) to obtain treatment for chidamine (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 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 the 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. In China, the incidence of peripheral T-cell lymphoma accounts for about 25%-30% of non-Hodgkin’s lymphoma, which is significantly higher than the 10%-15% in European and American countries. %. Based on the Phase 2b study data of 55 patients with aggressive PTCL in Japan, the HBI-8000 study data shows that although the disease is at an advanced stage, is refractory, and recurring, it still has a meaningful tumor response and progression-free duration. Sidaben The listing of amines is expected to address the important unmet medical needs in this patient population.