On June 24, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported that HBI-8000 will be marketed under the brand name Hiyasta in Japan (Press release, HUYA Bioscience, JUN 24, 2021, View Source [SID1234584367]). Hiyasta was recently approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of adult T-cell leukemia/lymphoma (ATLL) as monotherapy.
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Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "Today’s approval of Hiyasta for ATLL came in just 9 months. Our commercial partnership with Meiji will now bring Hiyasta to patients and provide much needed public health benefit for this devastating, life threatening disease."
Hiyasta was also submitted to the PMDA in March for approval as monotherapy to treat peripheral T-cell lymphoma (PTCL). In addition, the ODD designation for Hiyasta in Japan has been formally approved for both ATLL and PTCL.
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.
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