HUYABIO Announces HBI-8000 Brand Name of Hiyasta™

San Diego, CA, USA – June 24, 2021 – HUYABIO International (HUYABIO™), the leader in accelerating   global development of China’s pharmaceutical innovations, announced today that HBI-8000 will be marketed under the brand name Hiyasta™ in Japan. 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.

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 and maximize value globally. For more information, please visit www.huyabio.com.

Contact details:

Bob Goodenow, PhD President

+1.858.342.2430

bgoodenow@huyabio.com

Yiota Merianos

Corporate Communications

+1.858.353.1217

ymerianos@huyabio.com

HUYABIO International Receives Regulatory Approval for HBI-8000 Monotherapy of Adult T-cell Leukemia/Lymphoma in Japan

HUYABIO’s partner Meiji Seika to market the drug in Japan

San Diego, CA, USA – June 23, 2021 – HUYABIO International (HUYABIO™), the leader in accelerating global development of China’s pharmaceutical innovations, today announced the regulatory approval for HBI-8000 monotherapy of relapsed or refractory (R/R) adult T-cell leukemia/lymphoma (ATL) by the Japanese Pharmaceuticals and Medical Devices Agency.

“Relapsed and/or refractory ATLL carries a grim prognosis with limited treatment options. Data from the registration study of HBI-8000 has demonstrated meaningful disease response despite the advanced stage of disease, and acceptable safety profile, to address an important unmet medical need in this patient population”, said Dr. Atae Utsunomiya, honorary hospital director of Imamura General hospital in Japan.

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

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, “This first regulatory approval for our lead oncology drug, HBI-8000, is a major milestone for the Company. The durability and strong immuno- oncology properties of HBI-8000 set the stage for improved cancer treatment of both solid and liquid tumors. Synergy with PD-1/PD-L1 inhibitors hold particular promise for major solid tumor advances.”

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 ATL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATL 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.

Contact details:

Bob Goodenow, PhD President

+1.858.342.2430

bgoodenow@huyabio.com

Yiota Merianos

Corporate Communications

+1.858.353.1217

ymerianos@huyabio.com www.huyabio.com

Jay W. Mason, MD

Jay W. Mason, MD

/

University of Utah, Spaulding Clinical Research

 Dr. Mason has served as a Cardiology consultant to HUYABIO since 2017. He is Professor of Medicine (Cardiology) at the University of Utah, Chief Medical Officer at Spaulding Clinical Research, and an independent consultant in cardiac safety. He obtained his undergraduate degree at Princeton University and his MD degree at the University of Pennsylvania. Dr. Mason trained in Medicine and Cardiovascular Diseases at Stanford University where he was a member of the Faculty from 1975 to 1983 and served as Director of the Cardiac Arrhythmia Service and Co-director of the Cardiac Catheterization Laboratories. He became Chief of Cardiology at the University of Utah in 1983. In 1999 he was appointed Chairman of the Department of Medicine at the University of Kentucky. From 2003 to 2007 he served as Medical Director and Director of R&D at Covance Cardiac Safety Services. His clinical, teaching and research emphasis is in cardiac arrhythmias, electrocardiography and electrophysiology. Dr. Mason chaired the American College of Cardiology’s electrocardiography educational committees for over 20 years and currently chairs or serves on several nationally sponsored safety monitoring boards and scientific initiatives. He has been awarded more than $29M in NIH support during his research career and is author of over 485 research publications. 

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