HUYA Bioscience International Submits HBI-8000 Monotherapy for Adult T-cell Leukemia/Lymphoma for Regulatory Approval in Japan

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San Diego, CA, USA – October 6, 2020  HUYA Bioscience International (HUYABIOTM), the leader in accelerating global development of China’s pharmaceutical innovations, today announced the submission of a regulatory application to the Japanese Pharmaceuticals and Medical Devices Agency for HBI-8000 monotherapy for relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL). 

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said,The submission of the regulatory application in Japan for R/R ATL is a significant milestone for HUYABIO. The durability and strong immuno-oncology properties of HBI-8000 sets the stage for improved cancer treatment of both solid and liquid tumors. We look forward to drug approval and a positive impact on the quality of life of these patients.”

The new drug application is based on data from a Phase 2b study that involved 23 patients with aggressive ATL in Japan. These patients all had advanced disease either refractory or relapsed after receiving mogamulizumab and had few effective treatment options. HBI-8000 40mg orally administered twice weekly resulted in disease response in a clinically meaningful proportion of patients with an acceptable safety profile. 

“Aggressive ATL is primarily a disease of the elderly with a poor three-year survival rate of 25%. There are few effective treatment options. It remains to be an important unmet medical need in Japan and a challenging public health issue. Clinical data from HBI-8000 has shown the promise to fulfill such a need. Orphan Drug Designation has been granted to HBI-8000 for R/R ATL, and peripheral T-cell lymphoma”, said Dr. Bob Goodenow, President of HUYABIO.

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 deacetylase (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 ATL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATL cells more sensitive to immune cytotoxicity targeting.

About HUYA Bioscience 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 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

Contact details:
Bob Goodenow, PhD
+1.858 354.2430

Yiota Merianos
Corporate Communications

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