On April 6, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported the submission of a regulatory application to the Japanese Pharmaceuticals and Medical Devices Agency for HBI-8000 monotherapy for relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) (Press release, HUYA Bioscience, APR 6, 2021, View Source [SID1234577612]).

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"R/R PTCL carries a poor prognosis. The benefit of chemotherapy diminishes with each subsequent relapse. Data from the Phase 2 study of HBI-8000 has demonstrated meaningful tumor response and progression-free duration despite the advanced stage of disease, to address an important unmet medical need in this patient population ", said Dr. Kensei Tobinai, visiting scientist of the National Cancer Center Hospital in Japan and medical expert of HBI-8000 Phase 2 study.

The new drug application is based on data from a Phase 2b study of 55 patients with aggressive PTCL in Japan. These patients all had advanced disease, refractory or relapsed relative to prior therapies. 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 is an important Public Health contribution as R/R PTCL patients will have an effective treatment alternative. It is our second regulatory submission for drug approval in Japan in 6 months and we continue to work hard to benefit patients with difficult to treat diseases."

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) enzymes to induce cell cycle arrest, suppress the expression of a number of oncogenes and modulate the of acetylation of PD-L1 to enhance the activity of immune checkpoint inhibitors. The drug also has immunomodulatory impact by increasing the efficacy of checkpoint inhibitors in preclinical animal models.