Shenzhen Chipscreen Biosciences' licensing partner, HUYABIO International (HUYABIO™), today announced the regulatory approval for Tucidinostat (also known as Chidamide, Epidaza ®, HBI-8000) monotherapy of relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL) by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
"Relapsed and/or refractory ATLL carries a grim prognosis with limited treatment options. Data from the registration study of Chidamide has demonstrated meaningful disease response despite the advanced stage of disease, and acceptable safety profile, to address an important unmet medical need in this patient population", said Dr. Atae Utsunomiya, honorary hospital director of Imamura General hospital in Japan.
The drug was approved based on data from a Phase 2b study that involved 23 patients with aggressive ATL in Japan. These patients, having few effective treatment options, all had advanced disease either refractory to or relapsed after receiving mogamulizumab. Chidamide 40mg orally administered twice weekly resulted in disease response in a clinically meaningful proportion of patients with an acceptable safety profile.
Dr. Lu Xianping, Chairman and President of Chipscreen said, "this is an exciting news and important milestone for our licensing partner HUYABIO International and we wish them continue success in the global development of Chidamide for several other indications".
About Chidamide (Tucidinostat as INN also known as Epidaza ®, HBI-8000)
Chidamide is a first-in-class/best-in-class innovative medicine targeting selectively histone deacetylases (HDAC) 1, 2, 3 and 10, which was discovered and developed originally by Shenzhen Chipscreen Biosciences in China. It has unique epigenetic immunomodulatory activities approved and launched in Chinese market for the treatment of malignant T cell lymphoma at 2014 and metastatic breast cancer at 2019. It is currently at several late stage clinic studies for several other indications in China. The product's ex-China rights were licensed out from Chipscreen to HUYABIO at 2006. Later on, HUYABIO partnered with Meiji Seika for Japanese market.