HUYABIO International Receives Regulatory Approval for HBI-8000 Monotherapy of Adult T-cell Leukemia/Lymphoma in Japan
SAN DIEGO, June 23, 2021 /PRNewswire/ -- HUYABIO International (HUYABIO™), the leader in accelerating global development of China's pharmaceutical innovations, today announced the regulatory approval for HBI-8000 monotherapy of relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL) by the Japanese Pharmaceuticals and Medical Devices Agency.
"Relapsed and/or refractory ATLL carries a grim prognosis with limited treatment options. Data from the registration study of HBI-8000 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. HBI-8000 40mg orally administered twice weekly resulted in disease response in a clinically meaningful proportion of patients with an acceptable safety profile.
Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This first regulatory approval for our lead oncology drug, HBI-8000, is a major milestone for the Company. The durability and strong immuno- oncology properties of HBI-8000 set the stage for improved cancer treatment of both solid and liquid tumors. Synergy with PD-1/PD-L1 inhibitors hold particular promise for major solid tumor advances."
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