SAN DIEGO, CA, USA – October 19, 2021 – HUYABIO International (HUYABIO™), the leader in accelerating global development of China’s pharmaceutical innovations, today announced the product launch in Japan for Hiyasta® tablets to treat relapsed and/or refractory (R/R) adult T-cell leukemia/lymphoma (ATLL).
Japanese patients with relapsed and/or refractory R/R ATLL have very poor prognosis. The effectiveness of available treatments, such as chemotherapy, diminishes with each relapse. Results from the HBI-8000 study in these patients have demonstrated clinically meaningful tumor response despite the advanced stage of disease. The treatment was safe and side effects could be managed with routine care. “In my opinion, this treatment is expected to address an important unmet medical need,” said Dr. Kensei Tobinai, Visiting Scientist of the National Cancer Center Hospital in Japan and medical expert of the HBI-8000 Phase 2 study.
HUYABIO recently announced the approval of Hiyasta® by the Japanese Minister of Health, Labor and Welfare based on the results of a clinical trial conducted in Japan in patients with R/R ATLL. Meiji Seika Pharmaceuticals, HUYABIO’s partner, will market the product in Japan. HUYABIO retains worldwide rights to the drug ex-Asia. Development of HBI-8000 is ongoing globally.
Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, “This first product launch for our lead oncology drug, HBI-8000, is a major milestone for HUYABIO as we transition into a revenue generating Company. It demonstrates our global reach and ability to develop and commercialize products licensed from China for debilitating diseases and make a major public health contribution.”
HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylases (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATLL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATLL cells more sensitive to immune cytotoxicity targeting.
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. 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.