Shenzhen Chipscreen Biosciences' licensing partner, HUYABIO International (HUYABIO™), today announced the regulatory approval for Chidamide (Tucidinostat, also known as Epidaza ®, Hiyasta®, HBI-8000) monotherapy for the treatment of relapsed or refractory (R/R) PTCL by the Ministry of Health, Labour and Welfare in Japan.
"Relapsed and/or refractory PTCL carries a grim prognosis with limited treatment options. Data from the registration study of Chidamide 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. Kensei Tobinai, Visiting Scientist of the National Cancer Center Hospital in Japan and medical expert of Chidamide Phase 2 study.
The drug was approved based on data from a Phase 2b study that involved 55 patients with aggressive PTCL in Japan and Korea. These patients, having few effective treatment options, all had advanced disease either refractory to or relapsed to prior therapies. Chidamide 40mg orally administered twice weekly resulted in a 46% Objective Response Rate, median Progression-Free Survival of 5.6 months and a median Overall Survival of 22.8 months.
Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This second regulatory approval for our lead oncology drug, Tucidinostat(also known as Hiyasta®), in Japan expands our drugs' indications for patients with severe hematologic malignancies. We are looking forward to additional future indications for Tucidinostat that will benefit even more patients."
Dr. Lu Xianping, CEO & President of Chipscreen said, "Tucidinostat, an original new drug independently discovered and developed by Chipscreen, its ex-China rights were licensed out to Huya in 2006. Today, the Japanese approval on Tucidinostat for the treatment to peripheral T-cell lymphoma is another important milestone for the product's expansion in overseas markets. We sincerely thank our partner Huya International. This new approval enables us to provide Tucidinostat for Japanese patients who are suffering from PTCL. It is also a remarkable step of Chipscreen in the way of providing affordable antitumor drugs for global patients. Via conducting further clinical research of Tucidinostat monotherapy and relevant combination therapies with other antitumor drugs, we are expecting to continuously make new progress to benefit patients all over the world who are suffering from other types of cancers."
About Chidamide (also known as Epidaza®, Hiyasta®, HBI-8000)
Chidamide is a first-in-class/best-in-class innovative drug which was discovered and developed originally by Shenzhen Chipscreen Biosciences in China. It is an Epigenetic Immunomodulator approved and launched in Chinese market for the treatment of lymphoma and metastatic breast cancer. It also has demonstrated immunomodulatory impact and is being tested in a global pivotal trial in melanoma combined with the checkpoint inhibitor Nivolumab. The product's ex-China rights were licensed out from Chipscreen to HUYABIO. Later on, HUYABIO partnered with Meiji Seika for Japanese market.