On October 19, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported the product launch in Japan for Hiyasta tablets to treat relapsed and/or refractory (R/R) adult T-cell leukemia/lymphoma (ATLL) (Press release, HUYA Bioscience, OCT 19, 2021, View Source [SID1234591519]).
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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."
About HBI-8000
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.