This is the second indication for Hiyasta® in Japan following adult T-cell leukemia/lymphoma (A TLL)
SAN DIEGO – HUYABIO International, the leader in accelerating the 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.”
HBI-8000 is an epigenetic immunomodulator with several approved indications including monotherapy for two subtypes of Non-Hodgkin’s Lymphoma in Japan and in combination therapy for metastatic breast cancer in China. This oral agent targets class I histone deacetylases causing cell cycle arrest and tumour cell death as the mechanism underlying its single-agent activity against lymphoma. The drug also has demonstrated immunomodulatory impact and is being tested in a global pivotal trial in melanoma combined with the checkpoint inhibitor nivolumab.
About HUYABIO International
HUYABIO™ is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. Hiyasta® is the company’s first commercial product marketed in Japan. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.
Bob Goodenow, PhD President
Yiota Merianos Corporate Communications