Japan’s regulatory body, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), has granted HUYABIO International, Shenzhen Chipscreen Biosciences’ licensing partner, regulatory approval for leukemia drug therapy, Tucidinostat. Tucidinostat, also referred to as Chidamide, Epidaza ®, HBI-8000, is a monotherapy designed to treat refractory or relapsed adult T-cell leukemia/lymphoma. PMDA’s approval was based on Phase 2b study data of 23 patients that had aggressive forms of leukemia/lymphoma. Japan’s Imamura General Hospital Honorary Hospital Director, Dr. Atae Utsunomiya, stated, “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.”

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