HUYABIO International Receives Regulatory Approval for Hiyasta Monotherapy for Peripheral T Cell Lymphoma in Japan

“Relapsed and / or refractory PTCL has a poor prognosis with limited treatment options. Data from the HBI-8000 registration study demonstrated clinically meaningful responses despite the advanced stage of the disease and an acceptable safety profile to address a significant unmet medical need in this patient population, ”said the Dr Kensei Tobinai, Visiting Fellow at the National Cancer Center Hospital in Japan and medical expert of the phase 2 HBI-8000 study.

The application of the additional indication for R / R PTCL is based on data from a Phase 2b study involving 55 patients with aggressive PTCL in Japan and Korea. These patients all had advanced, refractory or relapsing disease compared to previous treatments. HBI-8000 40 mg taken orally twice weekly resulted in an objective response rate of 46%, a median progression-free survival of 5.6 months, and a median overall survival of 22.8 months.

Dr Mireille Gillings, CEO and Executive Chairman of HUYABIO said: “This second regulatory approval for our leading oncology drug, Hiyasta, in Japan expands the indications of our medicines for patients with severe malignant hemopathies. We look forward to additional future indications for Hiyasta that will benefit even more patients. “

About Hiyasta
HBI-8000 is an epigenetic immunomodulator with several approved indications, including monotherapy for two subtypes of non-Hodgkin lymphoma in Japan and in combination therapy for metastatic breast cancer in China. This oral agent targets class I histone deacetylases causing cell cycle arrest and tumor cell death as a mechanism underlying its activity as a unique agent against lymphoma. The drug has also demonstrated immunomodulatory impact and is currently being tested in a global pivotal melanoma trial associated with the checkpoint inhibitor nivolumab.

About HUYABIO International
HUYABIO is the leader in accelerating the global development of new opportunities for biopharmaceuticals originating in China, enabling faster, more profitable and lower risk drug development in global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, she has built the largest portfolio of compounds of Chinese origin covering all therapeutic areas. Hiyasta is the company’s first commercial product marketed in Japan. With offices in the United States, Japan, South Korea, Canada, Ireland, and eight strategic locations across China, the company has become a partner of choice in accelerating product development and maximizing value at worldwide. For more information, please visitwww.huyabio.com.

SOURCE HUYABIO International