HUYABIO International Receives Regulatory Approval For Hiyasta® Monotherapy Of Peripheral T-Cell Lymphoma In Japan
SAN DIEGO, Nov. 30, 2021 /PRNewswire/ -- HUYABIO International, the leader in accelerating global development of China's pharmaceutical innovations, today announced the regulatory approval of HBI-8000, brand name Hiyasta®, monotherapy for the treatment of relapsed or refractory (R/R) PTCL by the Ministry of Health, Labour and Welfare in Japan.
"Relapsed and/or refractory PTCL carries a grim prognosis with limited treatment options. Data from the registration study of HBI-8000 has demonstrated clinically meaningful responses despite the advanced stage of disease and acceptable safety profile to address an important unmet medical need in this patient population", said Dr. Kensei Tobinai, Visiting Scientist of the National Cancer Center Hospital in Japan and medical expert of HBI-8000 Phase 2 study.
The application of the supplemental indication for R/R PTCL is based on data from a Phase 2b study of 55 patients with aggressive PTCL in Japan and Korea. These patients all had advanced disease, refractory or relapsed relative to prior therapies. HBI-8000 40mg orally administered twice weekly resulted in a 46% Objective Response Rate, median Progression-Free Survival of 5.6 months and a median Overall Survival of 22.8 months.
Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This second regulatory approval for our lead oncology drug, Hiyasta, in Japan expands our drugs' indications for patients with severe hematologic malignancies. We are looking forward to additional future indications for Hiyasta that will benefit even more patients."
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SOURCE HUYABIO International